Long-awaited, the next generation of drug-eluting stents (DES) made entry to the U.S. market in early February with FDA approval of the Endeavor DES from Medtronic (Minneapolis).
Similar to the roll-outs of the first DES devices in 2004 and 2005 – the Cypher from Cordis (Miami Lakes, Florida) and the Taxus from Boston Scientific (Natick, Masssachusetts) – market uptake of the Endeavor will be closely watched, from two points of view: the Endeavor’s ability to elbow aside the first-generation products and the ongoing trial and physician evaluation of the device.
The first two FDA-approved DES devices rushed to 80% of stent use, early on, and combined worldwide sales of about $5 million. But the last two years have seen stagnating to declining use, based on a series of studies indicating safety problems and a general questioning of angioplasty/stenting for heart patients.
This opens the dorr wide for the Endeavor and the Xience V, made by Abbott Laboratories (Abbott Park, Illinois), expected to win the next DES approval, and the approval of these send-generation devices may be one reason why the DES market has fallen on hard times.
The Endeavor stent utilizes zotarolimus as the drug coating and the device/drug combination demonstrated good efficacy and safety in data presented to the FDA, and the cardiovascular device panel that recommended its approval last October.
An analysis of pooled safety data from the ENDEAVOR trial reported a thrombosis rate for Endeavor patients of less than 1% within the first year, and a 0.08% rate from one year to three years, post-implant. The same analysis revealed low cumulative rates of all safety measures out to three years of follow-up: stent thrombosis (0.7%); myocardial infarction (2.7%); and cardiac death (1%).
The company said that Endeavor “has shown numerically fewer adverse events across all key safety measures vs. a bare-metal stent. Of particular note from this analysis, just 3.5% of Endeavor patients experienced cardiac death or myocardial infarction through three years of follow-up, compared to 6.6% of patients who were BMS-implanted.”
ENDEAVOR IV, a randomized controlled trial comparing the Endeavor stent with the Taxus stent, met its primary endpoint, with a target vessel failure (TVF) rate in Endeavor patients of 6.6% at nine months. The TVF rate for Taxus patients at nine months was 7.2%.
Endeavor had similar efficacy compared to Taxus for all lesion subsets analyzed, and there were no statistically significant differences in target lesion revascularization (TLR), a clinical measure for repeat procedures.
Compared to a BMS in ENDEAVOR II, Endeavor had fewer repeat procedures by more than 61% at nine months. This treatment effect is sustained, with only 7.3% of Endeavor patients in this randomized controlled trial requiring a repeat procedure out to three years of follow-up.
With Endeavor approval, Medtronic is not wasting any time making the stent available to physicians. Scott Ward, president of Medtronic’s CardioVascular business, told Biomedical Business & Technology that the company is initiating commercialization immediately. “We will be shipping about 100,000 units to U.S. hospitals in the next 30 days to assure full availability,” Ward said.
He added that the company is anticipating “blockbuster demand” for the Endeavor stent, he added.
Ward saidthat Medtronic will conduct a 2,000-patient post-approval study in the U.S., combined with another trial outside the U.S. with 3,300 patients. In addition, he said, the company plans to collaborate with FDA to conduct a trial intended to identify the optimal duration of dual antiplatelet therapy following angioplasty and Endeavor DES placement.
Medtronic said in a statement that “Ultimately, the ENDEAVOR clinical program will enroll more than 22,500 patients followed to five years.” It said that more than two-thirds of enrollees will be implanted with the Endeavor.
Elsewhere in the product pipeline:
• Abbott (Abbott Park, Illinois) said that it received FDA approval for its fully automated HTLV-I/HTLV-II blood screening test for use on the Abbott Prism instrument. The test is intended for use by laboratories to screen individual donations of blood and plasma for antibodies to human T — lymphotropic virus Type I and/or human T — lymphotropic virus Type II (anti-HTLV-I/HTLV-II). HTLV-I and HTLV-II are closely related but distinct retroviruses associated with several diseases including human T-cell leukemia and neurological disorders, according to the Centers for Disease Control. The Prism instrument consolidates testing into a single system automating many of the manual testing procedures and steps currently used to screen blood. Safety features built into the system help track and monitor each sample throughout the testing process providing documentation and quality control for testing facilities. The Prism system can run 160 samples per hour, making it possible to test more than 1,200 samples per eight-hour shift. Abbott Diagnostics makes in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics.
• Abiomed (Danvers, Massachusetts) said that it has developed a new portable circulatory support driver for both in-hospital and out-of-hospital patients. The portable driver is designed to support Abiomed’s AB5000 ventricular assist device. The combination of the new driver and the company’s FDA-approved AB5000 VAD provides support of acute heart failure patients. The AB5000 can assume the pumping function of a patient’s failing heart, allowing the heart to rest, heal and potentially recover. AB5000 is designed to provide either uni-ventricular or bi-ventricular support. Abiomed’s portable driver is a bi-ventricular system that delivers the pressures and vacuums equivalent to Abiomed’s AB5000 console and its iPulse console. Testing showed that the portable driver is capable of providing full support for a year’s intended use. The unit is expected to require low maintenance, approximately every 5,000 hours of operation. Abiomed’s AB5000 has FDA approvals for all acute heart failure indications.
• ACR Image Metrix (Philadelphia) will conduct a multi-reader clinical study to determine whether the addition of the iCAD CT Colon Computer-Aided Detection (CAD) system enables radiologists interpreting CT colonography images to detect more cancers than they would without using the iCAD system in the image interpretation process. ACR Image Metrix will work with iCAD to develop and execute a clinical study to support FDA approval of CT Colon CAD. CT colonography uses virtual reality technology to produce three-dimensional, “fly through” images that permit a thorough and minimally invasive evaluation of the entire colorectal structure for cancer and precancerous polyps. CAD computer software would then search the CT images obtained for abnormal areas of density or mass that may indicate the presence of cancer and precancerous polyps. The CAD system highlights these areas on the images, alerting the radiologist to the possible need for further analysis. ACR Image Metrix offers a complete menu of imaging CRO services, from study design to design of electronic data forms and image archiving, to image interpretation and quantitation. iCAD is a provider of Computer-Aided Detection (CAD) solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing cancer earlier.
• Aethlon Medical (San Diego) reported that researchers have demonstrated the effectiveness of the Aethlon Hemopurifier in capturing the highly-fatal H5N1 strain of the Avian Flu Virus (Bird Flu). In pre-clinical studies, high concentrations of H5N1 flu virus (~ 3 million flu virus/ml) were observed to be rapidly depleted from cell culture fluids when circulated through the Hemopurifier. The study data indicated that during a six-hour testing period, the Hemopurifier removed up to 99.4% of infectious H5N1 flu virus. Verification of viral capture was documented by both real-time PCR and conventional plaque assay (TCID 50) measurements. The recent discovery that H5N1 avian influenza virus can spread via the bloodstream to organs and other regions of the body typically not attacked by influenza viruses explains in part, the high virulence of H5N1 infection and why it remains a serious pandemic threat. Aethlon Medical makes therapeutic devices for infectious disease.
• Alphatec Holdings (Carlsbad, California) reported introduction of the Dynamo semi-rigid spinal system. Alphatec’s complete solution combines the Dynamo semi-rigid rod with the rigid stabilization of Alphatec’s Zodiac spinal fixation system to offer a new segmental solution for treating different stages of spinal degeneration at contiguous levels. The Dynamo provides surgeons with the flexibility to address varying degenerative indications and patient needs by matching the magnitude of stabilization needed for each of the multiple levels of spinal degeneration. Alphatec Holdings makes products for the surgical treatment of spinal disorders.
• Amylin Pharmaceuticals (San Diego) reported the availability of the SymlinPen 120 and the SymlinPen 60 pen-injector devices for administering Symlin (pramlintide acetate) injection. These new pre-filled pen-injector devices feature simple, fixed dosing to improve mealtime glucose control. SymlinPen 120 features fixed dosing to deliver 60 or 120 micrograms of Symlin per dose. SymlinPen 60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms of Symlin per dose. Symlin is an injectable medicine used to control blood sugar after meals in adults with Type Type 1 or Type 2 diabetes who take mealtime insulin. Symlin is a synthetic analog of human amylin, a naturally occurring hormone that is made in the beta cells of the pancreas, the same cells that make insulin. In patients with Type 2 diabetes who use insulin, and in patients with Type 1 diabetes, those cells in the pancreas are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals.
• AngioDynamics (Queensbury, New York) said that it launched Centros, a self-centering, tunneled hemodialysis access catheter. The distal end of the catheter has a curved configuration; placed in the superior vena cava (SVC), its curved tips keep the ports of the catheter centered in the SVC, away from the vein walls. The tips of the catheter are not placed in the atrium, but in the lower third of the SVC. AngioDynamics makes medical devices used by interventional radiologists, nephrologists and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease.
• Aperio Technologies (Vista, California) received FDA clearance to market the manual read of digital HER2 slides from a computer monitor using its patented ScanScope digital slide scanning system. The FDA-cleared system is intended for use as an accessory to the Dako HercepTest to aid pathologists in the detection and semi-quantitative measurement of HER2 protein expression to assess breast cancer patients for whom Herceptin treatment is being considered. The FDA clearance encompasses the company’s complete digital pathology system, including ScanScope scanners for creating digital slide images from microscope slides, and the Spectrum digital pathology information management system for managing, viewing, and analyzing digital slides. Aperio makes digital pathology for the healthcare and life sciences industry.
• Baxa (Englewood, Colorado) reported the launch of the MedBoard web-based medication tracking system, designed to record pharmacy preparation and delivery activities. MedBoard helps health systems improve productivity through order prioritization and delivery assurance, reducing time spent fielding nursing calls and tracking order status. With the tracking system, pharmacies can manage workflows using barcode technology, and can provide tracking for doses that are not part of pharmacy ADCs. The system requires only a web browser and handheld scanners to get started. MedBoard uses technical, administrative and policy safeguards to ensure data security, and is HIPAA compliant. Baxa makes technologies for fluid handling and delivery.
• Cardica (Redwood City, California) reported the launch of its new C-Port xA X-Change Distal Anastomosis System, now commercially available in the U.S. The C-Port is a cartridge-based, reloadable C-Port system, which allows surgeons to attach multiple blood vessel grafts using the same handle during a coronary artery bypass graft (CABG) procedure. The C-Port accommodates cartridges pre-loaded with staples, allowing a surgeon to complete multiple anastomoses using the same CO2-powered handle. Each device in the C-Port system product line is designed to enable automated, reliable and reproducible connections of blood vessels during cardiac bypass surgery. Unlike most hand-sewn anastomoses, Cardica’s C-Port systems create compliant anastomoses that can expand and contract with blood flow. In addition, the C-Port anastomosis systems, whether used during on- or off-pump surgery, offer surgeons unique access to a wide range of coronary arteries, particularly small coronary arteries, which, in the past, have been difficult or impossible to connect effectively. Cardica makes automated anastomosis systems for CABG surgery.
• CeloNova BioSciences (Newnan, Georgia) reported results from the Atlanta study of the Catania Coronary Stent System with NanoThin Polyzene-F at the 20th Annual International Symposium on Endovascular Therapy (ISET). Features of the Catania includes: early and complete vessel healing, as early as 30 days; patients can discontinue dual anti-platelet therapy after only one month; protection from stent thrombosis; and the Polyzene-F surface treatment is bacterial-resistant. CeloNova BioSciences specializes in products using their material, Polyzene-F.
• A simple test can accurately identify which newborn babies are at risk for developing dangerous levels of jaundice, according to researchers at The Children’s Hospital of Philadelphia (Philadelphia). While neonatal jaundice, a yellowing of the skin caused by a buildup of a blood product called bilirubin, is common in newborns and usually disappears on its own, it can progress to brain damage in a small fraction of cases.
• Coloplast (Minneapolis) has expanded its new SenSura line, featuring the Circle of Security for those with an ostomy. The newest product, SenSura Click, is a two-piece pouching system that comes six months after the launch of the SenSura brand and its one-piece system. SenSura products feature Coloplast’s Circle of Security – a new barrier technology that is the first to optimize five core needs: initial tack and adhesion, flexibility, absorption, erosion resistance and ease of removal. The SenSura Click two-piece pouching system uses the same barrier technology as the one-piece system with the addition of an easy-to-apply, click-lock security ring. Coloplast specializes in ostomy care.
• CoolTouch (Roseville, California) reported that the CoolLipo 1320 nm laser system received an additional 510(K) clearance from the FDA for laser lipolysis, or melting fat. The CoolLipo 1320 laser is designed to ablate fat in areas such as the neck, chin and arms and improves the outcome of conventional liposuction in larger areas such as the abdomen and thighs. In addition, the 1320 nm wavelength tightens the skin from the inside out by directly targeting collagen and connective tissue. CoolTouch makes medical lasers.
• Covidien (North Haven, Connecticut) reported the U.S. introduction of the AbsorbaTack 5 mm absorbable mesh fixation device for hernia repair. The AbsorbaTack 5mm absorbable tacks provide strong mesh attachment to the surrounding tissues, while reducing the amount of foreign material remaining in the patient long-term. Coupling the absorbable fixation of the AbsorbaTack with Covidien’s Parietex mesh, a hydrophilic polyester mesh that establishes intimate tissue integration, offers an appropriate clinical solution. Covidien specializes in pharmaceutical products, imaging solutions, medical supplies, and retail products.
• CryoCor (San Diego), focused on the treatment of cardiac arrhythmias, reported today the publication of a European study of atrial fibrillation (AF) patients treated with its Cardiac Cryoablation System to evaluate the role of atrial flutter in the recurrence of AF and the effectiveness of an ablation strategy focused on isolating the pulmonary veins to treat the AF. The study was published in the Dec. 11, 2007, issue of Circulation. The study prospectively evaluated the best catheter ablation strategy in patients with paroxysmal AF with and without concomitant right atrial flitter (AFl). During follow-up averaging 26 months, the authors found that electrical isolation of the pulmonary veins by catheter ablation was successful in patients without concomitant (AFl) at an 82% success rate. In patients with concomitant AFl, the combination of ablation for AFL and pulmonary vein isolation alone to treat AF was frequently insufficient in preventing recurrences of AF (recurrence rate of 67%). The authors concluded that those patients with AFl and AF may require additional sites of ablation to effectively treat their atrial fibrillation. Luz-Maria Rodriguez, MD, senior author of the study, said, “This is the first time that an ablation strategy for paroxysmal atrial fibrillation and atrial flutter has been systematically studied. This has implications for the tools that a clinician may use to treat these atrial arrhythmias. Based on this study, we do not believe that it will be sufficient to simply isolate the pulmonary veins in a significant proportion of patients.”
• The FDA has approved a test that helps in assessing the risk of tumor recurrence and long-term survival for patients with relatively high-risk breast cancer, made by Dako Denmark (Glostrup, Denmark). Dako says that the TOP2A FISH pharmDx is the first approved device to test for the TOP2A (topoisomerase 2 alpha) gene in cancer patients. The product is The TOP2A gene plays a role in DNA replication. The TOP2A FISH pharmDx test uses fluorescently labeled DNA probes to detect or confirm gene or chromosome abnormalities, a technology known as fluorescent in situ hybridization (FISH). Changes in the TOP2A gene in breast cancer cells mean there is an increased likelihood that the tumor will recur or that long-term survival will be decreased. The test is suitable for breast cancer patients who are premenopausal or for whom tumor characteristics, such as tumor size or lymph node involvement, suggest a higher likelihood of tumor recurrence or decreased survival. The product was studied in Danish patients who were treated with chemotherapy after removal of a breast tumor. The test is conducted on a small piece of the removed tumor, with the tissue then stained with the FISH chemicals and studied under a microscope.
• Echo Therapeutics (Franklin, Massachusetts) reported launch of the second clinical study of its Symphony continuous transdermal glucose monitoring system (CTGM System) at the Tufts-New England Medical Center. The company said it expects to report the results of the study this quarter. Echo’s current generation Symphony CTGM system consists of the FDA-cleared SonoPrep skin permeation device that incorporates permeation control technology, together with wireless conductivity and proprietary transdermal sensor technologies. In addition to providing glucose monitoring benefits to diabetes patients, Symphony is designed to help patients and healthcare teams in hospital critical care settings to better control glucose levels with accurate, needle-free, continuous glucose readings. The skin permeation feature of Echo’s current generation of Symphony CTGM System involves SonoPrep, Echo’s FDA-cleared device using ultrasound-mediated skin poration technology. Echo Therapeutics is a platform-enabled specialty therapeutics and diagnostics company developing a broad pipeline of both advanced topical reformulations of FDA-approved products using its AzoneTS dermal penetration technology, and Symphony, a wireless, needle-free, CTGM system for the diabetes and hospital critical care markets.
• EnteroMedics (St. Paul, Minnesota) reported commencement of its EMPOWER clinical study. The FDA recently granted approval for the study of the company’s investigational VBLOC therapy using the Maestro system, its initial product for the treatment of obesity. EMPOWER will evaluate the safety and effectiveness of the VBLOC vagal blocking therapy for the treatment of obesity at 15 clinical sites in the U.S. and Australia. VBLOC is delivered via the Maestro system through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low energy electrical impulses. VBLOC is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness. EnteroMedics makes medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders.
• Escalon Medical (Wayne, Pennsylvania) reported that its Sonomed subsidiary has received FDA clearance for the Master-VU ophthalmic B-scan ultrasound system. The system consists of a B-scan probe that can be interfaced to a standard personal computer (via a USB cable connection) using Sonomed’s software, thereby converting the personal computer into an ophthalmic ultrasound system. The Master-VU features include: measurement calipers for multiple intraocular measurements; the ability to save both 30-second “clips” as well as individual frames on a scrolling frame manager; and on-screen annotation capability, including text and graphics. Sonomed is a diagnostic ultrasound company specializing in the design, manufacture and distribution of instruments for ophthalmology. Escalon makes ophthalmic diagnostic, surgical and pharmaceutical products as well as vascular access devices.
• Ethicon (Somerville, New Jersey) said the FDA has granted an expanded indication for Evicel Fibrin Sealant (Human). The company said the product is the first fibrin sealant to be indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical. Evicel is the only all-human plasma-derived fibrin sealant commercially available in the U.S. It does not contain aprotinin, which has been associated with adverse effects. Evicel is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen liquid and requires less than one minute preparation time after thawing. Evicel is contraindicated in individuals known to have anaphylactic or severe systemic reaction to human blood products. Ethicon, a Johnson & Johnson company, makes surgical products for use in general surgery, wound management and women’s health & urology.
• Haemonetics Software Solutions (Braintree, Massachusetts) reported FDA clearance for another software module in the Symphony blood bank management software suite. The Symphony 2.0 software will include a blood component manufacturing and distribution application, in addition to the blood donor management tools included in the previous software release. Symphony 2.0software is a blood component manufacturing and distribution system which allows blood centers to automate many of the IT processes in their blood supply chain, from the point of blood donation to the point of distribution to the hospital. Specifically, the Symphony software suite includes an automated donor self-interview application and can manage all steps in the collection of blood through manufacturing, labeling and release, inventory management, order entry, and, finally, distribution to the hospital. Haemonetics Software makes blood management solutions.
• Home Diagnostics (Fort Lauderdale, Florida) reported its new blood glucose test strip platform called TRUEtest. TRUEtest strips will use no-coding technology that automatically calibrates with the company’s upcoming TRUEresult and TRUE2go blood glucose meters. The TRUEresult meter will offer advanced performance features while TRUE2go will be the world’s smallest monitor for on-the-go testing. The new no-coding technology of TRUEtest strips will eliminate the need for users to code their TRUEresult and TRUE2go meters with each new box of test strips. This enhancement reduces the risk of inaccurate glucose results caused by miscoding or failure to change the code when a new box of test strips is used, the company said. Home Diagnostics makes diabetes-testing supplies.
• HP (Palo Alto, California) has introduced an archiving platform to help healthcare providers, hospitals and imaging clinics meet rapidly expanding retention requirements for medical images. With the HP medical archive solution (MAS) 3.0, healthcare providers can strengthen their focus on improving patient care while also adhering to strict compliance regulations by ensuring that medical image data is securely indexed, preserved and accessible, HP said. HP MAS 3.0 delivers HP ProLiant servers, HP StorageWorks SAN and MSA disk storage with indexing, policy management and search software to provide long-term retention of medical fixed content. The tiered storage of the MAS grid is designed to help healthcare providers align the business value of images with retention policies.
• Innocoll (Ashburn, Virginia) said that the first of two Phase III clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies, to investigate CollaRx Gentamicin Surgical Implant for the prevention of surgical site infections, has commenced dosing. The implant is a biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localized action, while maintaining low systemic levels well below the toxicity threshold. The product was developed using Innocoll’s proprietary collagen-based drug delivery technology, CollaRx, and (outside of the US) is indicated as an adjunct to systemic antibiotic therapy for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues. The cardiac surgery trial will enroll diabetic and/or obese (BMI>30) patients known to be at a higher risk of sternal wound infections, a serious and potentially life-threatening complication of cardiac surgery.
• InnoMed Technologies (Coconut Creek, Florida) said it is developing products designed specifically to assist Asian sufferers of apnea. InnoMed’s Nasal-Aire II Petite is a sleep interface that can accommodate the smaller nasal passages characteristic of traditional Asian features. “Since no facial features are the same,” the company says, the interface delivers air directly to the nose via a nasal cannula that comes in various sizes. The Nasal-Aire also comes with ergonomically designed Micro Headgear, featuring an elbow feature that reduces facial pressure points for added comfort.
• Isolagen (Exton, Pennsylvania) said that injections have been completed in the Phase III multi-center, double-blind, randomized, placebo-controlled clinical trials evaluating the Isolagen Therapy for the treatment of nasolabial folds, or wrinkles. Subjects have advanced to the follow-up period of the study. Isolagen also reported the completion of injections in the Phase II open label study designed to gather further safety and potential application information on the use of the Isolagen Therapy for the full face. The subjects in this study also have advanced to the follow-up period, it said. Isolagen is an aesthetic and therapeutic company.
• Labcyte (Sunnyvale, California) introduced a new member of its acoustic dispensing family, the Echo 520 liquid handler, developed for the medium-throughput laboratory. The 520 system provides precision transfers of solutions for the laboratory that needs to transfer as many as 100,000 solutions per day. The Echo 520 avoids loss of sample by adsorption onto tips and intermediate plates and uses the same acoustic droplet ejection (ADE) technology that has enabled pharmaceutical companies to reduce the volume of their assays while obtaining more reliable data, Labcyte said. The acoustic droplet ejection technologyapplications include compound management, assays, arraying, particle manufacturing, imaging mass spectrometry and live-cell transfer.
• Malcom (Tiverton, Rhode Island) introduced what it said is a new method for non-contact removal of microscopic flash from molded, cut, and skived medical parts such as catheters and personal care applicators. Malcom’s Leister LE-Mini Heater produces up to 1380 F and 0.35 to 1.06 CFM to remove microscopic hair-like flash from injection molded, cut, and skived parts instantly without open flames. This compact heater can be supplied with a variety of nozzles to match the application and only requires 120/230 V single-phase and 30 psi air. Malcom’s Leister LE-Mini Heater can be controlled via PLC and standard temperature controllers. Measuring only 1” in diameter x 10” in length, it offers integrated tool and heating element protection for long life and is available with optional built-in thermocouples. Malcom is a licensed Leister technologies distributor.
• Medtronic (Minneapolis) reported the U.S. launch of the AneuRx AAAdvantage stent graft on the new Xcelerant hydro delivery system, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall. In addition, Medtronic received FDA approval to introduce its latest generation of packaging materials for the launch of this product. The Xcelerant system will be used with the AneuRx AAAdvantage stent graft. The Xcelerant features an integrated sheath that is tapered on both ends. This dual-taper sheath is designed to facilitate insertion and retraction of the delivery catheter by minimizing the time that the surface area of the sheath is in contact with the artery wall. The integrated sheath also contributes to the system’s low profile characteristics, intended to enable excellent tracking and access through small vessels.
• Millennium Dental Technologies (Cerritos, California) reported the results of a peer-reviewed manuscript, published in The International Journal of Periodontics & Restorative Dentistry, demonstrating uniform histologic success in the treatment of moderate to severe gum disease using the Laser Assisted New Attachment Procedure (LANAP). Millennium Dental estimates that LANAP-licensed practitioners are treating over 14,000 patients nationwide annually. New connective tissue attachment and regeneration of root surface (cementum) was achieved in 100% of the cases in the human histology study using the PerioLase MVP-7 variable pulsed Neodymium: Yttrium-Aluminum-Garnet dental laser, designed especially for LANAP. Study results show the FDA-approved LANAP is now a legitimate treatment alternative to conventional scalpel/suture flaps surgery, Millennium said.
• Millipore (Billerica, Massachusetts) and Gen-Probe (San Diego) reported the launch of the first product from their collaboration to create faster, more robust tests for detecting contaminants in pharma and biotech manufacturing processes. The method combines Millipore’s sample prep methodologies with Gen-Probe’s nucleic acid technologies to deliver both speed and sensitivity in one microbial screening tool. The MilliProbe system uses real-time transcription-mediated amplification technology to detect targeted microbial contamination within hours compared to the days or weeks usually required to generate results using traditional culture-based technology. Faster detection allows biopharmaceutical manufacturers to take corrective action earlier in the production process, which reduces downstream processing risks, optimizes product yields, and improves final product quality. Millipore provides bioscience research and biopharmaceutical manufacturing. Gen-Probe makes nucleic acid tests.
• A new creatinine monitoring system from Nova Biomedical (Waltham, Massachusetts) enables simple, rapid, and accurate assessment of renal function by finger prick capillary blood sampling at the point of care, according to the company. Incorporating new patented, Multi-Well test strip technology adapted from Nova’s hospital glucose monitoring system, Nova StatSensor Creatinine allows creatinine to be measured with a simple 30 second test in the emergency department, radiology, oncology, or other point-of-care areas where renal function must be assessed. StatSensor Creatinine measures creatinine and calculates estimated glomerular filtration rate (eGFR) by MDRD or Cockroft-Gault equations. Creatinine with eGFR is a more accurate and sensitive measurement of kidney function than creatinine alone. StatSensor Creatinine interfaces with hospital and laboratory information systems. Nova makes blood gas/electrolyte analyzers in hospitals and chemistry analyzers for cell culture and fermentation in biotechnology.
• Ocean Optics (Dunedin, Florida) introduced the RedEye Oxygen Patch which uses a combination of sensing material and optical sensing technologies. The RedEye self-adhesive, non-invasive patch enables quick readings of the presence or absence of oxygen and provides quantitative measurements. The patch can be integrated into the surface of sample containers such as blood bags, pill blister packs, or point of care analysis devices like disposable ventilator oxygen attachments, to permit non-invasive, through-the-package oxygen concentration measurements. RedEye coatings are capable of monitoring low levels of oxygen in gas and dissolved oxygen in liquids, as well as the higher oxygen levels present in cell culture and respiratory monitoring. Ocean Optics makes miniature photonics.
• Olympus America (Center Valley, Pennsylvania) said that the FDA has cleared the Olympus PK7300 automated microplate system for use in the U.S. The FDA has also licensed blood grouping and phenotyping reagents specifically formulated and manufactured exclusively for use on the PK7300 instrument. Designed for blood donor centers, the system will offer the performance that has made Olympus the leader in the field. Olympus systems test more than 90% of the North American blood supply. The newest member of the PK7000 series utilizes the same proven technology, agglutination in the Olympus microtiter plates, as its predecessors – the Olympus PK7100 and PK7200 systems. The PK7300 system will also offer users enhanced process control features, increased throughput, upgraded computer hardware and software, and reduced maintenance. Olympus makes high-throughput automated blood bank instruments.
• The FDA approved expansion of the indications for a liquid fibrin sealant to help control bleeding during general surgery. The sealant, called Evicel, made by Omrix Biopharmaceuticals (Kiryat, Israel), is sprayed or dripped on small, oozing blood vessels to form a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications. Evicel contains fibrinogen and thrombin, two proteins involved in the production of fibrin. Fibrinogen and thrombin are found in human plasma, the liquid portion of blood. The plasma used to manufacture the product is collected from donors who have been screened and tested for blood-transmitted infections. Omrix is an international bioscience company specializing in innovative, life-saving products.
• Orthovita (Malvern, Pennsylvania) said it has made a 510(k) filing to the FDA for the use of its Cortoss bone augmentation material in vertebral augmentation, based on data from three U.S. clinical investigations conducted under FDA investigational device exemptions and several European studies and intended to demonstrate that the performance of Cortoss is substantially equivalent to polymethylmethacrylate (PMMA) bone cement. The clinical study of CORTOSS demonstrates that the same degree of clinical improvement in pain and function is achieved with approximately 40% less material than PMMA when augmenting the vertebral body, Orthovita said. The Cortoss filing includes data on 469 vertebral compression fracture patients treated with Cortoss and 94 patients treated with PMMA with follow up ranging from 11 months to over 3 years.
• Respironics (Murrysville, Pennsylvania) reported the release of the OmniLab™ multi-mode titration system. The device is intended to help sleep technicians titrate more types of patients than ever before. The device incorporates six modes of therapy, with multiple technologies which can be accessed directly from a PC. The company said that sleep technicians can choose the most effective therapy for each patient from one system. Patients can be titrated without interruption as they won’t need to move to another room in order to be titrated on a different system. Many therapy modes, some incorporating Respironics patented comfort technologies are available to permit titration of almost any patient type, including pediatric patients (age 7 and older, and greater than 40 pounds, in CPAP, BiPAP S, BiPAP S/T, T and PC modes). The PC Direct software package makes changing patient mode settings and pressures quick and easy. A technician can simply adjust patient parameters directly from the computer monitor. The last patient pressure settings can be printed directly to a prescription sheet. Kevin Dorcak, product marketing manager of Respironics, said, “The OmniLab contains two of our most advanced technologies, BiPAP autoSV for patients with various forms of Central Apneas (such as Complex and Mixed Apneas and Cheynes-Stokes Respiration) and BiPAP AVAPS for patients with underlying, progressive respiratory conditions that require frequent changes over time, such as restrictive thoracic, neuromuscular and obesity hypoventilation disorders.” Respironics is a manufacturer and distributor of products and programs that serve the global sleep and respiratory markets.
• RSB Spine (Cleveland) reported the first implantation of its InterPlate L in the lumbar spine. RSB Spine also has completed the national rollout of its InterPlate C device for use in the cervical spine. The company also expects to introduce two new InterPlate products manufactured from a radiolucent polymer (PEEK, polyetheretherketone) later this year. Fusion is one of the most common spinal procedures performed by neurosurgeons and orthopedic spine surgeons. The InterPlate C and InterPlate L are designed to facilitate rapid fusion and are used in conjunction with graft material to fuse spinal vertebrae. RSB Spine is a privately held medical device company focused on making innovative spinal implants.
• Sangart (San Diego) said that it has started testing its lead product, Hemospan, in a Phase II clinical study involving chronic critical limb ischemia (CCLI) patients. The study is designed to evaluate the safety and efficacy of Hemospan in patients suffering from CCLI, a debilitating condition that results from severely limited blood circulation to the legs. The primary endpoint is tissue oxygenation measured noninvasively. Hemospan is a hemoglobin-based oxygen transport agent designed to serve as an oxygen therapeutic and as an alternative to blood transfusions. A key property of Hemospan is its high oxygen affinity which results in targeted oxygen delivery to tissues at risk of oxygen deprivation. Sangart makes oxygen transport agents.
• Smiths Medical (St. Paul, Minnesota), part of the global technology business Smiths Group, said it has received FDA clearance for its P.A.S. Port T2 Power P.A.C. and Port-a-Cath II Power P.A.C. dual-lumen implantable access systems. The new products expand the existing port line from seven to 10 systems available for power injections of contrast media. Implantable access systems provide a route of delivery for patients requiring long-term medications such as chemotherapy. The portal is implanted under the skin, usually in the chest, and connected to a catheter which threads into a vein. Power-injecting is performed when a patient requires a contrast enhanced computed tomography scan for diagnostic reasons. The power injection procedure requires a higher pressure and flow rate than standard medication infusions so an additional IV line traditionally had to be placed in the patient.
• SpineVision (San Francisco) said that preliminary data from an ongoing postmarketing study show that its FDA-cleared PediGuard device allows a two-fold reduction of the risk of inadvertent pedicle screw misplacement during lumbar degenerative spine surgery. In addition, the preliminary results show that the use of PediGuard leads to a six-fold reduction of medial breaches, and suggest an approximately 10% decrease in average screw-placement time, as well as a reduction of surgeons exposure to radiation by about 30%. According to the company, PediGuard is the first wireless, hand-held instrument capable of accurately detecting changes in tissue type, thus alerting surgeons to potential pedicular or vertebral breaches during pedicle screw site preparation. SpineVision makes motion preservation and fusion devices for spine specialists.
• The first fully automated ablation system supporting an open-loop irrigated catheter using remote navigation with the Niobe magnetic navigation system, designed by Stereotaxis (St. Louis) and the Carto RMT system by Biosense Webster (Diamond Bar, California), has received FDA approval. The system uses the Navistar RMT Thermocool Irrigated Tip Catheter and the Coolflow Pump from Biosense Webster, with the Stockert RF Generator. The catheter incorporates small irrigation holes at the tip to provide cooling during RF ablation. The addition of the Niobe magnetic system and the Carto RMT system provides electrophysiologists with accurate 3-D mapping, targeting and remote navigation the companies said. Biosense Webster, a Johnson & Johnson company, makes diagnostic navigation and mapping tools. Stereotaxis makes cardiology instrument control system for use in a hospital’s interventional surgical suite.
• St. Jude Medical (St. Paul, Minnesota) reported FDA clearance for its EnSite Fusion Registration Module, new software to help physicians create detailed heart models to facilitate the diagnosis and delivery of therapy for complex abnormal atrial heart rhythms, including atrial fibrillation. EnSite Fusion software registers, or integrates, an EnSite System-created chamber model with a three-dimensional computed tomography (CT) model so that the physician has an improved view of the heart’s anatomy to better guide the delivery of therapy. EnSite Fusion has the capability for “dynamic registration,” which allows for adjustments fusing the EnSite System-created and CT-derived models, giving physicians a more detailed image of the heart. Dynamic registration allows physicians to adjust the EnSite System-created model at key anatomic locations to more precisely adapt to the 3-D, CT model.
• Third Wave Technologies (Madison, Wisconsin) said that the company has achieved the subject enrollment goals for its HPV-products clinical trial. The total enrollment target was comprised of 2,000 normal subjects and 1,400 women with atypical, or ASCUS, Pap test results. The next steps in the clinical trial include obtaining the final colposcopy and biopsy data, validating and locking down the database, opening the database, and completing and submitting the FDA PMA applications. Third Wave makes molecular diagnostic reagents for a variety of DNA and RNA analysis applications to meet the needs of our customers.
• Three Palm Software (Los Gatos, California) reported receiving FDA clearance for its WorkstationOne Breast Imaging Workstation. WorkstationOne is intended for softcopy reading and interpretation of digital mammography images, and was developed with the goal of assisting radiologists to read digital mammograms efficiently. WorkstationOne incorporates viewing methodology, including Tabar’s systematic viewing technique for searching for subtle abnormalities on the mammograms. The workstation, supporting IHE integration profiles and the display of CAD markers, is a software system that can be installed on an off-the-shelf general purpose computer with one or two gray scale high resolution monitors and one color monitor. Three Palm Software specializes in development of medical imaging software.
• ThromboVision (Houston) said that it has initiated clinical trials of its ThromboGuide (T-Guide) platelet function monitor. The T-Guide consists of a disposable test kit and a point-of-care base unit. The system will help physicians improve their cardiac patients’ lives by individualizing antiplatelet therapy that they use to prevent heart attacks, strokes and stent occlusions. ThromboVision has licensed the patented technology developed by scientists affiliated with the Utah Artificial Heart Institute, Brigham Young University and the University of Utah. ThromboVision develops biomedical diagnostics.
• Varian Medical Systems (Palo Alto, California) reported launch of a family of Pursuit columns for high performance liquid chromatography with Pursuit XRs Ultra 2.8 and Pursuit UPS 2.4. These new columns allow chromatographers to analyze samples faster while achieving higher resolution and reducing the cost per analysis, the company said. Both columns are intended for use by analytical chemists in pharmaceutical and environmental laboratories for the separation, identification and quantification of sample components.
Varian also reported FDA clearances for its Rapid-Arc radiotherapy technology, making it possible to deliver image-guided, intensity-modulated radiation therapy (IMRT) two to eight times faster and more precisely than possible with conventional IMRT or helical tomotherapy. RapidArc delivers a complete IMRT treatment in a single rotation of the treatment machine around the patient. The two FDA clearances for RapidArc cover the treatment hardware and the RapidArc treatment planning software module in Varian’s Eclipse treatment planning system. RapidArc technology uses an algorithm that creates a finely-shaped IMRT dose distribution that matches the size and shape of the tumor and varyies three parameters simultaneously: speed of rotation, dimensions of beam-shaping aperture, and dose rate. Varian makes systems for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy and brachytherapy.
• VGX Pharmaceuticals (Blue Bell, Pennsylvania) reported completing its first study to assess the tolerability of VGX’s Cellectra electroporation device in humans. Ten healthy adult volunteers were treated with Cellectra device and were asked to report the level of discomfort they experienced immediately after electroporation and at various times thereafter. The procedure was generally well tolerated. On average, the patients reported a moderate level of discomfort during the procedure. However, the discomfort was short-lived, with comfort levels approaching baseline levels within 30 minutes following the procedure. Other complaints were mild and did not require any treatment. VGX manufactures DNA plasmid-based vaccines and therapies.