BB&T National Editor and Staff Reports

A blocked urinary tract can be a big problem, one that means frequent insertions and removals of catheter devices – usually the basic Foley catheter – and offering highly opportunistic possibilities for infections, those infections being a major source of nosocomial infections.

In both cases, the insertion/removal process and frequent infections, the consequences add up to huge healthcare costs and, for the patient, embarrassment and inconvenience to those who suffer from this problem.

Addressing both issues is early-stage firm Urovalve, located in the Enterprise Development Center at New Jersey Institute of Technology (Newark, New Jersey). The company is a developer of remote-controlled fluid valves used for managing the problems of urinary retention and incontinence.

Urovalve in early December reported launch of a pilot study of its Surinate Bladder Management System, for controlling the urinary flow in men who suffer from either acute or chronic urinary retention due to obstruction of the urethra.

President/CEO Harvey Homan, PhD, told Biomedical Business & Technology that the company hopes to complete the pilot study, of 15 men, by the end of January and then launch a pivotal study, of at least 50 men, which it hopes to complete in six months.

The company has received advice from a consultant at Quintiles (Research Triangle Park, North Carolina) for filing of a 510(k) which would allow, in the best case, FDA approval and commercialization by 2010.

As an alternative to the frequent insertions and removals of urinary catheter devices – sometimes multiple times a day – the Surinate system provides for a single insertion in a 28-day cycle, leaving no tubes or other materials outside the body, such as a urine-collection bag, and enabling the individual to void urine from his bladder by using a magnetized valve control.

Besides greatly reducing the chance of urinary infection, the valve system provides for its unobtrusive operation, providing lifestyle normalcy.

The ability to avoid infection, especially of the hospital-related type, is a huge money-saver, putting Urovalve on an important savings wave.

"We think we're in front of the wave," Homan said. "The issue of the health problems associated with catheters is more serious than has been acknowledged."

The system targets both acute and chronic urinary retention, the acute condition often related to prostate problems and treatments, the chronic condition frequently related to spinal cord injury and other conditions causing paralysis.

Homan said that the exact number of patients that might use the system is difficult to calculate exactly. But with millions of men with prostate problems and many thousands with spinal cord injuries, the population that could use the Surinate is potentially in the "hundreds of thousands, if not in the millions ... We're going to have to understand over time exactly what that number is ... ."

When the Surinate is inserted, one end is placed in the bladder and expands into a cage, with urine then flowing down through sphincters above and below the prostate toward the control valve.

The valve is operated by a switching magnet. The patient simply moves a thumb-sized magnet close to the scrotum in order to open the valve to permit urine to flow through the urethra and then moves the magnet away to close the valve and stop the flow.

The system is inserted in the urologist's office. Because of a natural buildup of dead cells and other deposits, it must be removed after 28 days and, in the case of chronic obstruction, a new system is then inserted.

The system for inserting the Surinate is withdrawn, leaving nothing outside the body, a key feature of the system helping to avoid infection, Homan noted.

The pilot study is being conducted at four sites: VA Boston Healthcare System; VA New Jersey Healthcare System (East Orange); Vanderbilt University Medical Center, Department of Urologic Surgery (Nashville, Tennessee); and the Virginia Urology Center (Richmond).

Elsewhere in the product pipeline:

• Advanced Sterilization Products (Irvine, California) reported the availability of the Cleanascope, a new infection-prevention solution designed to reduce the risk of cross-contamination of endoscopes and cross-infection of patients in healthcare facilities that provide GI procedures. The Cleanascope is a storage and transportation system that offers visual identification of clean versus contaminated endoscopes. It is available in four sizes – 2-tray, 5-tray, 6-tray and 10-tray version – and its sterile liners can be reordered as needed. The system can be used in combination with manual and automated reprocessing systems.

• Aragon Surgical (Palo Alto, California) said it has received FDA clearance for the IntelliSeal OS12, the first instrument in its platform of radio frequency products that will cross a broad array of specialties. The OS12 was designed with gynecologists for use in abdominal, or open, hysterectomy. The IntelliSeal product line uses TissueSense technology in all of their electrosurgical instruments and systems. This unique energy delivery platform serves as the foundation for several open and laparoscopic surgical instruments. IntelliSeal electrosurgical systems are designed to reduce operative time and improve patient safety.

• ATS Medical (Minneapolis) reported the first three commercial implants of the ATS 3f aortic bioprosthesis. The ATS 3f aortic bioprosthesis is the company's first entry into the tissue valve market. The tubular design of the ATS 3f maintains the continuity of the annulus and the sino-tubular junction. No other valve mimics the native valve in this manner. By maintaining this continuity, the company said the ATS 3f preserves the aortic sinuses and restores native valve stress distribution and physiologic blood flow. This design provides surgeons and patients with a potentially more durable solution to aortic valve replacement, according to ATS.

• BD Diagnostics (Burlington, North Carolina) has received FDA pre-market approval for the BD FocalPoint GS Imaging System. This system is designed to enhance cervical cancer screening for cytology laboratories using the BD SurePath Pap test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions. The system's guided screening technology helps rapidly relocate the fields of view that the system has identified as the most likely to contain cells of interest.

• Biospace med (Atlanta) reported that data from a clinical study of its FDA-cleared EOS 3-D X-ray orthopedic imaging system conducted by a Montreal hospital, "EOS: A New Breed of X-Ray Imager Using Low-Dose Slot-Scanning to Achieve High-Quality Images," showed that the EOS ultra-low-dose orthopedic imaging system makes possible "better image quality than CR (computed radiography) imaging while using nearly 10 times less radiation." EOS is designed to capture head-to-toe images of patients in a standing, weight-bearing position while reducing up to 90% of the radiation dose compared to a conventional X-ray and up to 1,000 times less radiation than a conventional CT scan.

• Bovie Medical (Melville, New York) said it received FDA clearance to market its SEER tissue resection device intended for initial use in liver oncology surgery. The SEER device uses conductive sintered steel as an electrode for radio frequency (RF) for cutting and coagulation. The process involves delivery of RF current and sterile saline for resection and coagulation in surgical procedures.

• Cardium Therapeutics' (San Diego) InnerCool Therapies operating unit said it has developed a pelvic cooling catheter system called UroCool, which is designed to induce localized cooling during surgery for prostate cancer (radical prostatectomy). The UroCool catheter is being incorporated into ongoing clinical studies at the University of California, Irvine, which are designed to provide additional information regarding the safety and usefulness of cooling during robotic-assisted prostate surgery.

• Cerus (Concord, California) said that it has initiated a Phase I clinical trial of its Intercept Blood System for red blood cells. Developed to improve the safety of red blood cell transfusions, the system is designed to inactivate pathogens that may be present in donated red blood cells, while preserving the blood products' therapeutic properties. The randomized, single-blind, controlled, multi-center Phase I clinical trial of the Intercept system is expected to enroll about 28 healthy subjects. Each subject will receive two transfusions of his own donated red blood cells in a randomized sequence, one with Intercept-treated red blood cells and the other with untreated red blood cells. The clinical trial will compare the post-transfusion recovery and lifespan of Intercept-treated red blood cells with conventional, untreated red blood cells.

• DePuy Mitek (Raynham, Massachusetts) reported the launch of the Healix BR dual-threaded anchor system, the first suture anchor for arthroscopic rotator cuff repair made with the company's Biocryl Rapide biocomposite material, shown in pre-clinical trials to resorb and promote bone formation within the implant profile. Healix BR is an extension of the Healix PEEK family of anchors. Both anchors are designed to independently engage cortical and cancellous bone, maximizing pull-out strength and potentially minimizing re-tears. Healix anchors are available in three sizes (4.5 mm, 5.5 mm and 6.5 mm), and may be pre-loaded with Orthocord, the company's high-strength suture.

• Evalve (Menlo Park, California) said long-term data published in EuroIntervention showed that the expected decrease in Mitral Vale Area (MVA) after repair with the MitraClip system to correct mitral regurgitation (MR) is not associated with clinically significant mitral stenosis. Additionally, with two years of follow-up, none of the patients treated with the MitraClip system required surgery for mitral stenosis. At 12 months no important differences were reported between the use of one or two MitraClip devices or based on the etiology of MR. The analysis was conducted to assess diastolic mitral valve function after percutaneous repair. Echocardiographic measurements of MVA and mean trans-Mitral Valve Gradient were made in 96 patients implanted with the MitraClip device.

• FlowMedica (Fremont, California) said it received FDA clearance for a new labeling indication for the Benephit Infusion Systems. The system can now facilitate targeted renal therapy (TRT) in patients who have demonstrated symptoms of or are at risk of developing Acute Kidney Injury. The Benephit Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient.

• Innocoll (Ashburn, Virginia) said FDA has designated the company's Gentamicin Surgical Implant as a fast-track development program. Gentamicin is being evaluated in two Phase III clinical trials as an adjunct to systemic antibiotic administration for the prevention of surgical site infections in patients who are at higher risk of developing surgical site infections. The Gentamicin implant is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin.

• InterCure (New York) reported the U.S. release of its next-generation hypertension treatment device, RESPeRATE Ultra. It features a large, enhanced display, fewer buttons and a simple menu; the unit was crafted to not only provide the same blood pressure reduction results as its predecessor, but also provide an enhanced, pleasurable device-guided breathing experience. The RESPeRATE Ultra also includes an interactive tutorial that guides the user to quickly learn to use the device to most effectively lower his or her blood pressure.

• IP2Biz (Atlanta) said a prototype wound measurement camera is being tested by wound specialty nurses at the Shepherd Center (also Atlanta). The hand-held device determines and captures wound boundaries and wound area using software and low-cost hardware. The company says the device provides fast, accurate and repeatable digital documentation of wound progression, a necessary component to validate payment from insurance and government agencies.

• Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) said it has introduced the MGMT gene methylation assay using methylation-specific PCR technology licensed from OncoMethylome Sciences. Methylation of the MGMT gene promoter has been shown to be a common event in brain cancers and predictive of response to some therapies.

• Lab Express (Phoenix) said it has introduced a new at-home colon cancer screening kit. The new Immunoassay Colorectal Cancer Screening (iFOBT) promises results in seven to 10 days. Lab Express says iFOBT eliminates false positives and false negatives to offer a more accurate result. Importantly, iFOBT will help more people that shy away from colonoscopies by providing a viable alternative.

• Light Sciences Oncology (LSO; Bellevue, Washington) reported the completion of enrollment in a global Phase III clinical trial of light infusion therapy (Litx) as a treatment for unresectable hepatocellular carcinoma (HCC), also known as hepatoma or primary liver cancer. The primary endpoint of the clinical trial is to assess the survival of patients receiving Litx therapy versus those receiving standard-of-care therapies. Litx is designed as an entirely new mode of therapy compared with the older, laser-based generation of light-activated drug therapies. The single-use, disposable Litx device uses light-emitting diodes to activate LS11 (talaporfin sodium), a light-activated, water-soluble drug.

• Luminex (Austin, Texas) reported the sale of the first Flexmap 3-D system manufactured in Austin. Full market release of the instrument is expected in 1Q09. The company says that the Flexmap 3-D system uses its flexible xMAP technology, which rovides both protein and nucleic acid applications on one platform.

• Medicsight (London), a subsidiary of MGT Capital Investments, reported the submission of a 510(k) pre-market approval notification to FDA for clearance to market its ColonCAD image analysis software throughout the U.S. Colon CAD technology represents a breakthrough in radiology, providing a tool which can assist radiologists in the detection of colonic lesions. If detected early, colon cancer is often treatable, making Medicsight's Colon CAD technology attractive to both patients and healthcare systems alike.

• Medtronic (Minneapolis) reported the U.S. launch of the Talent abdominal stent graft on the Xcelerant Hydro delivery system. EVAR is a treatment for aortic aneurysm, a dangerous bulge or weakening in the body's main artery that can rupture with fatal consequences if left untreated. EVAR involves the navigation of a stent graft, via the body's arteries, to the aorta. The stent graft is then deployed to create a reinforced tube within the aorta, reducing pressure on the aneurysm and the risk of rupture. Separately, Medtronic reported the U.S. market launch of the Endeavor Sprint drug-eluting stent (DES) on a rapid exchange delivery system, making its flagship DES even easier for physicians to deliver to the site of coronary blockages.

• Merge Healthcare (Milwaukee) reported the release of MergeCOM-3 Version 3.9, which adds the latest DICOM standard supplements to its industry-leading DICOM toolkit. Medical imaging software developers depend on MergeCOM-3 to jump-start product innovation by providing much of the code needed to incorporate the DICOM standard, the basic "language" by which all medical imaging devices and systems communicate.

• A simple and inexpensive developmental diagnostic assay produced by MicroPhage (Longmont, Colorado) was shown to be highly accurate for rapid detection of serious staph bacteria infections and for simultaneous assessment of antibiotic susceptibility. MicroPhage scientists reported that their novel platform to simultaneously identify Staphylococcus aureus bloodstream infections and determine antibiotic resistance or susceptibility can provide highly accurate results in just five hours. The current standard of care is 48 to 72 hours for the same determinations.

• Naviscan (San Diego) received FDA clearance for its biopsy-guidance feature designed exclusively for use with its high-resolution organ-specific PET scanner. The scanner's breast application is positron emission mammography (PEM). Stereo Navigator, the PEM-guided biopsy accessory, is indicated for the localization of lesions in female breasts, as identified on a PET image. This guidance system will now enable physicians to guide compatible interventional devices toward abnormalities visible on PET. The accessory uses a stereotactic frame fixed between the scanner's paddles to guide the insertion of a compatible interventional device into the breast.

• Nomir Medical Technologies (Waltham, Massachusetts) reported the presentation of in vivo human data for its Noveon direct optical energy device for treating methicillin-resistant Staphylococcus aureus (MRSA) colonization in the nose. The study demonstrated that light-based treatment with the Noveon resulted in reversal of microbial resistance to generic topical 2% erythromycin paste. The study confirmed two years of in vitro experimentation that indicate the device's method of action is due to a unique photo-inactivation effect. This method resulted in the eradication of erythromycin-resistant MRSA and erythromycin-resistant, methicillin-sensitive S. aureus in the human nose.

• OmniVision Technologies (Santa Clara, California) has introduced the OV6930, the latest addition to its portfolio of medical image sensors. The new low-power OV6930 is a 400 pixel by 400 pixel graphics array, or SquareGA, CMOS image sensor with an optical format of 1/10 inch and a packaged footprint of 1.8 mm x 1.8 mm, making it ideal for camera applications that require less than 2.8 mm outside diameter, such as medical endoscopes for minimally invasive medical procedures. The OV6930 uses a 3-micron OmniPixel3-HS pixel, which helps it to achieve low light performance of 3300 mV/Lux-second.

• Ortho Clinical Diagnostics (Raritan, New Jersey) received FDA clearance for its Vitros 5600 integrated system, designed to integrate clinical chemistry and immunoassay testing to increase laboratory productivity and will be able to perform more than 100 different chemistry, immunoassay and infectious disease assays on a single system.

• Osteotech (Eatontown, New Jersey) said its next-generation grafting material will be marketed under the brand name MagniFuse Bone Graft. MagniFuse is a combination of allograft bone within a polymer mesh that will provide targeted and contained delivery. The polymer mesh is made from a biodegradable suture material and is designed for effective cellular in-growth and complete resorption within three to six months, while not interfering with bone regeneration.

• PLC Systems (Franklin, Massachusetts) said it has received FDA approval for its U.S. pivotal trial to study the effectiveness of the company's RenalGuard System and associated therapy in the prevention of contrast-induced nephropathy. RenalGuard is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects.

• Pressure Products (Los Angeles) received FDA clearance to distribute the SafeSept transseptal guidewire, used in conjunction with a standard Brockenbrough transseptal needle when performing a transseptal crossing in the setting of atrial fibrillation and other invasive and electrophysiological atrial bi-chamber cardiology procedures. The SafeSept Transseptal Guidewire is designed to easily perforate the interatrial septum, immediately become atraumatic in the left atrium, enable fluoroscopic confirmation in the pulmonary veins, and allow safer over-the-wire advancement of the transseptal needle, dilator and introducer sheath into the left atrium.

• Response Biomedical (Vancouver, British Columbia) reported the initiation of a clinical trial of the company's RAMP test to detect respiratory syncytial virus (RSV). The study is designed to demonstrate the performance characteristics of the RSV test vs. standard laboratory culture and direct fluorescence staining assay (DFSA) for RSV using multiple sample types. Such a test would allow physicians to quickly diagnose the presence or absence of RSV virus and optimize the clinical management of the RSV-positive patient.

• Riverain Medical (Dayton, Ohio) saidtwo of the company's products, the OnGuard chest X-ray CAD system and the SoftView enhanced chest Imaging technology, have been awarded CE marks and Canadian device licenses. OnGuard works in conjunction with the reading of standard digital chest X-rays to quickly and comprehensively identify solitary pulmonary nodules that may be early-stage lung cancer. The SoftView technology creates an enhanced soft tissue image of the chest by suppressing bone on a standard chest X-ray.

• Siemens Healthcare (Deerfield, Illinois) said data from a new study published in the American Cancer Society journal Cancer, supports using the Siemens Serum HER-2/neu test to monitor patients with an aggressive type of metastatic breast cancer. This non-invasive blood test can be used to help monitor the widely-used Herceptin therapy. The Siemens Serum HER-2/neu blood test is intended to quantitatively measure the HER-2/neu protein in serum of women with metastatic breast cancer.

• Smith & Nephew's (Andover, Massachusetts) Endoscopy Division reported the launch of the Crosstrac hip guide system, which helps surgeons to accurately establish pathways to diagnose and repair the hip joint using arthroscopy, or minimally invasive, repair procedures. The Crosstrac is guided by an X-ray, and the surgeon establishes the first portal and inserts an arthroscope. With that portal in place, the Crosstrac is attached to the arthroscope and enables the surgeon to establish secondary portals in the appropriate place.

• Sonic Innovations (Salt Lake City) reported the launch of the Velocity 6 hearing device, described as a mid-level offering in the company's Velocity series.

• SonoSite (Bothell, Washington) reported the introduction of the S-FAST vascular access option, a streamlined, affordable solution for hospitals wanting to incorporate ultrasound into their emergency departments to facilitate the accuracy and safety of commonly performed interventional emergent procedures. The S-FAST vascular access option includes the L25x/13-6 MHz linear array transducer for high-resolution vascular imaging and access.

• Stryker Orthopedics (Mahwah, New Jersey) reported the release of its Tritanium Primary Acetabular System, which the company says is the only 3-D advanced fixation technology at a primary price point benefiting both patients and hospitals. The Tritanium technology is biologically inspired and designed to resemble trabecular bone, a type of spongy bone tissue that provides skeletal support. The 3-D Tritanium technology allows for bone to grow into the component, providing enhanced fixation.

• SurgiQuest (Orange, Connecticut) reported that the world's first 12 mm AirSeal single-incision laparoscopic supracervical hysterectomy with bilateral salpingo-oophorectomy was performed at Mt. Auburn Hospital (Cambridge, Massachusetts). The AirSeal creates an invisible pressure barrier that is self-contained within the cannula and does not rely on traditional gaskets or valves. It eliminates mechanical gaskets and valves from access ports and provides unobstructed access to the abdominal cavity without losing intra-abdominal gas pressure

• SyntheMed (Iselin, New Jersey) said it has received FDA clearance to market SinusShield, a bioresorbable membrane intended to prevent post-operative adhesions in nasal and sinus surgical procedures. SinusShield is indicated for use in patients undergoing nasal and sinus surgical procedures as a space-occupying stent to separate and prevent adhesions between mucosal surfaces.

• Synvista Therapeutics (Montvale, New Jersey) said it submitted an application for 510(k) clearance for its Haptochek diagnostic test kit. The submission begins a 90-day review process, during which the FDA will determine whether the kit can be distributed to labs throughout the country as an in vitro diagnostic.

• TomTec and Medis (both Munich, Germany) reported the launch of a joint cardiac imaging and analysis product for X-ray angiography and ultrasound. The combined solution is a software package that consists of TomTec's Image-Arena and Medis' QAngio XA quantification software. It will be available as one platform that can be integrated into the products of partnering medical device manufacturers and that connects to existing PACS, HIS, CPACS and CVIS in hospitals. Image-Arena reads vendor-independent data formats, and provides connectivity to existing PACS, HIS, CPACS and CVIS. QAngio XA is the industry-leading software solution for the analysis of peripheral and coronary vessels in angiograms.

• U-Systems (San Jose, California) reported plans to conduct a multi-center breast cancer screening study named somooInSIGHT, with more than 20,000 women, using its Automated Breast Ultrasound System (ABUS). The study will evaluate the sensitivity and specificity of X-Ray Mammography (XRM) and ABUS together, as compared to XRM alone, as a breast cancer screening method in women with greater than 50% parenchymal density.

• VIDA Diagnostics (Iowa City, Iowa) said its primary product, Pulmonary Workstation 2.0 (PW2) has received FDA clearance. PW2 takes the complex information from a CT scan of the lung and converts it into 3-D images and measurements that are viewed by the practicing pulmonologist at the point of patient service, or by the radiologist in the radiology department.

• Wound Care Innovations (Fort Worth, Texas) reported FDA clearance of a new wound management product utilizing its hydrolyzed collagen technology. The product line combines hydrolyzed collagen with the healing properties of polysulfated glycosaminoglycan (PSGAG) and will initially be available in gel form. PSGAG enhances the absorptive capacity of the hydrolyzed collagen gel, making it appropriate for the management of exudative wounds.