Tm Bioscience (Toronto) and the FDA reported last month that its Tag-It Cystic Fibrosis Kit is the first DNA-based blood test to assist in detecting cystic fibrosis (CF). It was approved as the first multiplexed human disease genotyping test and as an in vitro device for diagnostic use. Greg Hines, president and CEO of Tm Bioscience, said that approval of the test has unusually broad significance. It not only is the first FDA-approved genetic test for CF, he told The BBI Newsletter, but the first such test approved for a specific disease. This compares to other approved genetic tests that look at biomarkers for bacteria, viruses and enzymes indicators of, but not assays for, specific diseases. Thus, he noted that the FDA calls the Tag-It Cystic Fibrosis Kit, specifically, a "predicate device."

The FDA said the Tag-It Cystic Fibrosis Kit directly analyzes human DNA to find genetic variations indicative of the disease. The test will be used to help diagnose cystic fibrosis in children and to identify adults who are carriers of the gene variations. Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health, said that the test "represents a significant advance in the application of genetic technology and paves the way for similar genetic diagnostic tests to be developed in the future."

Tm Bioscience said the test is used to simultaneously detect and identify mutations and variants in the cystic fibrosis transmembrane conductance (CFTR) gene in human blood specimens in order to determine CF carrier status in adults, as an aid in newborn screening and in confirmatory diagnostic testing in newborns and children. The test which Hines said "has been run probably about 50,000 times" has proven that it operates with 100% accuracy and greater than 99.9% reproducibility and precision.

Elsewhere in the product pipeline:

Abiomed (Danvers, Massachusetts) reported that the FDA will convene an expert panel of cardiovascular surgeons and cardiologists on June 23 to consider the company's humanitarian device exemption (HDE) submission for its AbioCor artificial heart. The company has billed the AbioCor as "the first-ever completely self-contained artificial heart to come before the FDA for review." Abiomed originally filed its HDE application with the FDA last September.

Accumetrics (San Diego) has received a CLIA waiver for what President and CEO Rob Hillman calls a "new, improved version" of its VerifyNow Aspirin Test. The diagnostic test was initially approved by the FDA in 2003. The test allows a doctor to determine if a patient is going to be aspirin-resistant before relying on that over-the-counter drug to prevent further cardiovascular problems.

Angiotech Pharmaceuticals (Vancouver) reported positive preliminary safety results for its Vascular Wrap paclitaxel-eluting mesh trial. This first-in-man study is designed to evaluate the safety and performance of the Vascular Wrap in preventing stenosis after peripheral bypass surgery. The wrap is applied around the anastomosis site of a synthetic bypass graft and delivers drug to the blood vessel wall to prevent or reduce the renarrowing of an artery that typically follows this surgery, Angiotech said. The study randomized patients with peripheral vascular disease in a 2:1 fashion, the treatment arm enrolling patients with a synthetic bypass graft plus the Vascular Wrap mesh, the control arm enrolling patients with a synthetic bypass graft alone. Preliminary assessment at six months indicated that the Vascular Wrap was safe in this patient population, and there was no difference in safety between the two groups, Angiotech said. The study involved 109 patients at nine clinical centers in Europe as well as the Netherlands Antilles.

Biophan Technologies (West Henrietta, New York) reported results from testing of the company's technology that will enable MRI within vascular stents, allowing physicians for the first time to assess the health of stented arteries by means of non-invasive MRI technology. Currently, evaluation of restenosis within a stent requires an additional interventional procedure, and both of these procedures require the insertion of a catheter and guidewire into the patient. Biophan's technology to enable MR imaging within a stent would allow a non-invasive diagnostic procedure to provide similar data, eliminating the need for catheterization of the patient, exposure of the patient to ionizing radiation to obtain the X-ray image, and exposure of the patient to contrast agents. The technology employs the company's "active" MRI solutions, which it said use proprietary resonant frequency circuitry to enable superior visualization within an MRI.

Boston Scientific (Natick, Massachusetts) reported one-year data from its carotid artery stenting (CAS) clinical trial, BEACH. The study evaluates the effectiveness of stenting with embolic protection for patients who are at high-risk for carotid endarterectomy. The BEACH trial was designed to evaluate Boston Sci's Carotid Wallstent Monorail Endoprosthesis and the FilterWire EX and EZ Embolic Protection Systems. It is a prospective, non-randomized, single-arm clinical trial that enrolled 747 patients at 47 U.S. sites, with 480 patients in the pivotal phase of the trial. The trial also enrolled 189 patients in a "roll-in" group and 78 patients in a bilateral registry. The trial has a composite primary endpoint of cumulative mortality and morbidity through one year, consisting of stroke, death and myocardial infarction (MI). Christopher White, MD, co-principal investigator of the trial and director of the Ochsner Heart and Vascular Institute and chairman of Ochsner's department of cardiology, presented data showing a composite one-year endpoint of 9.1%.

Cardima (Fremont, California) said data from the Phase III trial of its Revelation Tx linear ablation microcatheter was published in the April 29 issue of the Journal of Interventional Cardiac Electrophysiology. Trial data indicated substantial and statistically significant improvements were realized almost uniformly for all measured arrhythmia symptoms as well as for quality-of-life measures. The study demonstrated that the addition of right atrial catheter ablation to a regimen of previously ineffective antiarrhythmic drugs yields a significant reduction in the frequency, duration and severity of atrial fibrillation (AF) episodes and symptoms. Of the 93 subjects included in the trial, 84 subjects (90%) provided six-month AF episode frequency data.

Cleveland Clinic (Cleveland) researchers have received a U.S. patent for technology they developed to measure damage to a person's blood-brain barrier, which is responsible for blocking foreign substances from reaching the brain. The patent was issued to Damir Janigro, PhD, and Gene Barnett, MD. Janigro is a professor of molecular medicine and director of cerebrovascular research for the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University (also Cleveland). Barnett is director of the Cleveland Clinic Brain Tumor Institute. The patent covers their work to develop a blood test capable of indicating when the blood-brain barrier has been compromised, if neuronal damage exists, and when the person might be more responsive to medications that need to reach the brain to treat tumors or other neurological disorders. Janigro said, "Manipulating, predicting and preventing the opening or closing of the barrier helps physicians treat patients with many different medical problems. This blood test is a quick and easy way to determine the most appropriate treatment for many different patients." The blood test would provide a minimally invasive alternative to the painful spinal taps for cerebrospinal fluid currently taken to assess the condition of a patient's blood-brain barrier.

Cook Biotech (West Lafayette, Indiana) reported FDA approval of its Surgisis AFP fistula plug, which the company said is "the first and only surgical device for repair of fistulas." A fistula is an abnormal channel that develops between body organs. The most common fistulas occur from the intestine to an opening in the skin. The Surgisis AFP device is for anal rectal fistulas, the indication for which the FDA clearance was received. Cook Biotech, a business of Cook (Bloomington, Indiana), was established in 1995 to develop products based on extracellular matrix (ECM) biomaterials. The Surgisis AFP device is based on this ECM technology. Over time, the Surgisis biomaterial takes on the cellular characteristics of surrounding tissue while it serves as a scaffold on which human tissue grows. As the biomaterial is replaced with cells, the scaffold no longer is needed and is absorbed by the body. The Surgisis AFP is a cone-shaped medical dev-ice that has been specifically designed to allow a surgeon to easily place it into a fistula channel. Once in place, Surgisis AFP serves as a bio-scaffold to facilitate well-organized tissue regeneration to close the fistula.

Dade Behring (Deerfield, Illinois) reported that it has received FDA 510(k) clearance for the Emit II Plus Ecstasy Assay, the company's rapid screening method for use in detecting the presence of ecstasy in human urine. The assay screens urine for methylenedioxymethamphetamine (MDMA, or Ecstasy), methylenedioxyethylamphetamine and methylenediox-y-amphetamine. It complies with proposed SAMSHA (Substance Abuse and Mental Health Services Administration) and European regulations. Dade Behring said the newest addition to its Syva drugs-of-abuse testing menu meets laboratory demand for an Ecstasy-specific test that includes a 500 ng/mL cutoff level. The new assay is intended to be used as a stand-alone test or in conjunction with the Emit II Plus Amphetamines Assay, which detects MDMA at higher levels than does this new Ecstasy-specific test.

DePuy Spine (Raynham, Massachusetts), a Johnson & Johnson business, reported launch of its Uniplate Anterior Cervical Plate System at the annual meeting of the American Association of Neurological Surgeons. The Uniplate is a new mid-line screw per vertebral body system on the market for one- or two-level cervical fusion procedures. It consists of a semi-rigid plate 10.5 mm wide that provides stability comparable to traditional cervical plates, but requires fewer screws resulting in fewer steps. The system is used to treat symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease, spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications. Through a small incision in the front of the neck, the damaged disc is removed and is replaced with a bone graft that will fuse the vertebrae together. The Uniplate has a thickness of 2.3 mm and includes a locking mechanism (Trilobe CAM-LOC) to secure the screws. It also includes the Universal Guide, an all-in-one tool acting as a plate holder through which an awl, drill, tap and screws can be inserted.

diaDexus (South San Francisco, California) is going for a second use for its PLAC test, which is now used to predict the risk of coronary heart disease in chronic patients. The company submitted a 510(k) premarket notification to the FDA seeking marketing clearance for the PLAC test as a diagnostic test to help predict the risk of stroke. The PLAC test is a blood test that measures an enzyme in the blood called lipoprotein-associated phopholipase A2 (Lp-PLA2). The company said that "large population studies" demonstrated that elevated Lp-PLA2 is associated with an increased risk of ischemic stroke. Study results presented at last November's American Heart Association scientific sessions suggested that just as in coronary heart disease high levels of Lp-PLA2 are believed to trigger a cascade of inflammatory events in atherosclerosis and can independently predict incre-ased risk of stroke, even after accounting for both traditional risk factors, such as blood pressure measurement, and novel cardiovascular risk factors. diaDexus secured approval of its PLAC test in coronary heart disease in July 2003.

Draxis Health (Mississauga, Ontario) said preliminary results from its Canadian trial indicate that Fibrimage imaged deep vein thrombosis (DVT) but that the review of patient data and charts is required to complete analysis of the trial. The target for filing a new drug submission (NDS) in Canada has been moved to the second half of 2005, pending the outcome of the analysis. The preliminary results from the Canadian trial indicate that Fibrimage successfully imaged DVT in patients with clinical symptoms that raised concern as to the presence or absence of DVT. Additionally, a Phase III clinical trial of Fibrimage in Canada closed in late 2004, and the first readings of scans were completed during the first quarter of 2005. Fibrimage was administered as a single intravenous injection and images of suspected sites of DVT in each patient's legs were taken using a gamma camera. The scans for each patient in the trial were benchmarked against the clinical assessment algorithm and the results of ultrasound evaluation.

Edwards Lifesciences (Irvine, California) has launched the FloTrac, a single-use sensor that connects to a catheter that is usually already in place in many critically ill patients' arteries and which works in conjunction with the company's new Vigileo monitor to combine data from the arterial pressure line with other patient parameters to automatically calculate cardiac output on a continuous basis. Until now, the company noted, patients whose conditions required monitoring beyond simple blood pressure measurements, but who were not candidates for more invasive monitoring technologies, were left with few options.

Endocare (Irvine, California), focused on the development of minimally invasive technologies for tissue and tumor ablation along with vacuum technologies for erectile dysfunction, said that data from a study performed at Columbia Presbyterian Medical Center (New York), and published in the journal Cancer, showed additional promising results for men who choose cryoablation as the primary means of treating prostate cancer, even when those patients were considered to be in a high-risk profile. The 65-patient study, in which the Endocare Cryocare system was used principally, examined the results of men who elected to have prostate cryosurgery as their primary therapy between January 1998-April 2002. All of the men in the study exhibited symptoms deemed high risk, including prostate-specific antigen (PSA) levels greater than or equal to 10 ng/mL and/or a Gleason sum score greater than or equal to 8. Following the procedure, patients were monitored via physical examinations and PSA screening every three months and with radiologic imaging in some cases. After a median follow-up period of 35 months, the PSA biochemical disease-free survival rate was 83% of patients, according to the American Society for Therapeutic Radiology and Oncology criteria. The overall survival rate at the time of publication was 100%.

Fujirebio Diagnostics (FDI; Malvern, Pennsylvania) has submitted a 510(k) application to the FDA for clearance of Mesomark, the first blood test for mesothelioma, a cancer caused by asbestos exposure that occurs in the lining of the body's organs, or mesothelium, usually in the chest cavity. Mesomark, a manual enzyme-linked immunosorbent assay (ELISA) is designed to work by identifying serum tumor markers called soluble mesothelin-related peptides (SMRP), the company said. Those peptides are released into the bloodstream by malignant mesothelioma cells. FDI's mesothelioma assay is a two-step immunoassay that quantitates SMRP in human blood using a standard ELISA microplate sandwich assay format. Fujirebio said that "up until now, there have been no reliable serum tumor markers" for mesothelioma.

Hospira (Lake Forest, Illinois) has introduced a new wireless version of the Hospira MedNet system, a customizable system that defines medication dose limits and tracks intravenous (IV) drug delivery to prevent dosing errors. The wireless component introduced at the American Association of Critical-Care Nurses (AACN; Aliso Viejo, California) 2005 National Teaching Institute and Critical Care Exposition combines Hospira MedNet medication management safety software with networking to provide scalable, upgradeable options for various facility sizes. The wireless version of MedNet establishes real-time send-and-receive capability and links to the hospital information network, providing easier access to drug dosing. Hospira MedNet is enhanced to store up to 2,700 IV drug and fluid names in a hospital-defined drug library, while providing specific limits for 18 clinical-care areas.

iCAD (Nashua, New Hampshire), a provider of computer-aided detection (CAD) for the early identification of cancer, reported submitting a 510(k) application with the FDA for its first product for use in the detection of lung cancer. As an image processing application intended to support computed tomography (CT) review workstation software, iCAD's lung cancer detection product is designed to make the medical review of lungs in CT scans more productive. The solution identifies roughly spherical objects in the lung that meet radiologist-specified size, shape and brightness criteria, enabling healthcare professionals to improve workflow by spending more time reviewing potential areas of lung cancer concern. Distribution agreements for iCAD's lung cancer detection products already are in place with TeraRecon (San Mateo, California) and Viatronix (Stony Brook, New York), both to begin product marketing following FDA clearance and product development and release plans are completed.

Kensey Nash (Exton, Pennsylvania) reported the final results of the FIRST (First European Investigation Regarding the Systematic use of the TriActiv Device) study, which was designed to examine cost-effectiveness of its TriActiv System in saphenous vein graft patients to support reimbursement for the device in Germany and European countries. The data was presented at the German Society of Cardiology meeting. TriActiv is an embolic protection system used during saphenous vein graft interventions to minimize major complications and is commercialized in both the U.S. and Europe. The FIRST study results showed that the TriActiv system substantially reduced 30-day MACE (major adverse cardiac events) compared to a historical control of patients treated without embolic protection. The reductions in complication rates will be used to generate a cost-effectiveness analysis of the TriActiv system. The FIRST study enrolled 196 patients at 17 sites in Germany.

Medtronic (Minneapolis) said that enrollment has begun in its ENDEAVOR IV clinical trial, the final phase of its ENDEAVOR clinical program to be used in support of premarket approval in the U.S. The first patient implant in the trial was performed by Charles O'Shaughnessy, MD, at EMH Regional Medical Center (Elyria, Ohio). ENDEAVOR IV is a randomized, single-blind trial evaluating the safety and efficacy of the Endeavor drug-eluting coronary stent as compared to the Taxus paclitaxel-eluting coronary stent system from Boston Scientific (Natick, Massachusetts). The ENDEAVOR IV study will include about 1,548 patients randomized one-to-one against the Taxus stent and will be performed at about 80 centers in the U.S. and Canada. The primary endpoint of the trial is target vessel failure at nine months, with a secondary endpoint of major adverse cardiac events at 30 days. The trial includes angiographic and Intravascular Ultrasound follow-up at eight months for a subset of 328 patients. Separately, Medtronic reported receiving approval from the FDA to add sequential biventricular pacing, known as V-V (ventricle-to-ventricle) timing, to its InSync Sentry and InSync Maximo cardiac resynchronization therapy defibrillators. V-V timing allows physicians to separately adjust the timing of electrical therapy delivered to the heart failure patient's two ventricles, which can optimize the beating of the heart and enhance the flow of blood throughout the body. In addition, the FDA approved a labeling modification for InSync Sentry and InSync Maximo systems to include use for heart failure patients who have prolonged QRS duration.

Medtronic Sofamor Danek (Memphis, Tennessee) reported the first enrollments in its PRESTIGE LP Cervical Disc clinical trial, saying it is its third artificial cervical disc trial designed to explore new technologies for the treatment of degenerative back disease. Having completed enrollment early last fall on both the Bryan Artificial Cervical Disc System and Prestige ST Cervical Disc investigational trials, Medtronic said it intends to advance cervical artificial disc technologies with the investigational device exemption (IDE) trial of the Prestige LP Cervical Disc. About 25 investigational sites will enroll some 275 patients. The Prestige LP Cervical Disc is made from a titanium ceramic composite material shown to have enhanced wear characteristics and improved imaging properties in laboratory testing. It incorporates two articulating components (ball on top and trough on the bottom) attached to the vertebral bodies. The ball and trough is designed to provide for replication of normal physiological motion. Dual stabilization rails and a plasma spray coating on each component are intended to help encourage biological fixation and long-term stability. The device is available in a variety of sizes to match patient anatomy. The Prestige is designed to maintain motion and flexibility while replacing a diseased disc removed from a patient's cervical area. The trial is being conducted to assess the safety and effectiveness of the Prestige in the treatment of symptomatic nerve root and/or spinal cord compression associated with degenerative disc disease.

Nanogen (San Diego) said that it has been issued European patent No. 0943158B1, "Affinity-based self-assembly systems and devices for photonic and electronic applications," by the European Patent Office. The new nanotechnology patent relates to a nanofabrication technology that combines an electric field-assisted manufacturing platform and programmable self-assembling nanostructures for the fabrication of a range of higher-order nano and microscale devices, structures and materials. The European patent is jointly owned by Nanotronics, a wholly owned subsidiary of Nanogen, and the Regents of the University of California (Oakland, California). Nanogen has exclusively licensed the interests of the University of California where there is joint inventorship.

Norwood EyeCare (Atlanta), a subsidiary of Norwood Abbey, reported results of three clinical studies on its Epikeratome for Epi-LASIK at the American Society of Cataract and Refractive Surgery meeting. The study results including the evaluation of visual acuity results, pain, haze and corneal sensitivity suggest that Epi-LASIK with the Norwood EyeCare Epikeratome is a safe and effective modality for the treatment of low and moderate myopia, based on a one-year follow up. One study compared patients who underwent Epi-LASIK and LASIK on cor-neal sensitivity. The study found that corneal sensitivity in Epi-LASIK patients was only slightly decreased during the first month and was fully recovered by the third postoperative month, while after LASIK it still was decreased as late as the sixth postoperative month.

Orqis Medical (Lake Forest, California), developer of the catheter-based Cancion cardiac recovery system (CRS) to treat congestive heart failure (CHF), reported that the FDA has granted an unconditional approval for researchers to treat up to 200 CHF patients at 40 centers participating in the company's MOMENTUM (Multicenter trial of the Orqis Medical CRS for the ENhanced Treatment of CHF, Unresponsive to Medical Therapy) pivotal clinical trial. The company previously reported conditional FDA approval in January to expand the MOMENTUM clinical investigation from eight to 40 centers nationwide after initially receiving a conditional approval for the trial last August. President and CEO Ken Charhut said that the big news was the panel's granting of an unconditional approval "Unconditional FDA approval to advance the MOMENTUM clinical investigation will allow us to discover its therapeutic potential." Since this is a new device, Charhut said there was a learning curve for the FDA to get comfortable with the system. "Once the FDA became familiar with the device," he said, "they became more comfortable at lessening the restrictions on the Cancion trial." First, the agency agreed to increase the number of centers from eight to 40 and now it has granted the study unconditional status.

Possis Medical (Minneapolis) said the FDA has cleared its 6 Fr DVX peripheral catheter to be labeled for breaking apart and removing thrombus from leg arteries greater than or equal to 3 mm in diameter. The DVX catheter features a redesigned tip that creates an enhanced and enlarged circulation pattern, resulting in significantly higher thrombus removal rates. The DVX catheter is intended to complement the existing 6 Fr Xpeedior peripheral catheter, which can be used for stand-alone thrombectomy as well as with the Power Pulse spray technique. The company said it would begin evaluations of the new DVX catheter at selected accounts to obtain customer feedback before a full commercial launch in the fourth fiscal quarter that ends July 31.

Roche Diagnostics (Indianapolis), a division of F. Hoffman-La Roche, said it has received FDA 510(k) clearance for the Accu-Chek Aviva meter, its newest blood glucose meter for the management of diabetes. The meter will be available for consumers in the U.S. later this year. The Accu-Chek Aviva meter is part of a broad portfolio of diabetes management tools developed by Roche Diagnostics to meet the diverse needs of people with diabetes.

Siemens Medical Solutions (Malvern, Pennsylvania), in collaboration with Massachusetts General Hospital (MGH; Boston), said it has developed a prototype area-detector based, volume computed tomography (CT) system. The system was developed on a Siemens Somatom Sensation CT gantry and uses 2-D digital flat-panel detector technology. Principles and potential applications of volumetric CT scanning are being evaluated at MGH with this prototype system. The new area-detector prototype CT system features volume coverage of 18 cm with up to 768 CT slices per rotation. When fully developed, this innovation has the promise of offering a unique window on human anatomy and physiology, the company said. Increased volume coverage is possible with the introduction of area detectors large enough to cover entire organs in a single rotation. The volume CT prototype system is designed to be suitable for in vitro imaging of specimens, as well as in vivo imaging of large animals and eventually human research.

St. Jude Medical (St. Paul, Minnesota) reported FDA approval of its QuickSite 1056T bipolar lead. The lead is used in CRT (cardiac resynchronization therapy) applications for heart failure patients. QuickSite leads offer a polyurethane-insulated body that transitions to a distal silicone-insulated tip section designed for optimal pushability, torque transfer and tip flexibility; a steerable, S-shaped distal tip designed to improve maneuverability and anchoring of the lead at distal as well as more proximal locations within the coronary sinus; and a choice of either a ball-tipped guiding stylet or a guidewire during the same implant for maximum flexibility in lead placement. The lead also features a radiopaque suture sleeve that enhances visibility on fluoroscopy without blocking visibility of the underlying coils; and a grooved, circumferential tip electrode designed to enhance stability and thresholds. The QuickSite 1056T bipolar lead is designed for use with the St. Jude Medical Epic HF CRT-D the Atlas+ HF CRT-D.

Synthetic Blood International (Costa Mesa, California) said it has enrolled its first two patients in its 60-patient Phase II Oxycyte trial to prevent tissue hypoxia in hip revision surgery. The company also reported that two hospitals in Durham, North Carolina, have received investigational review board approval. Oxycyte is the company's perfluorocarbon blood substitute and therapeutic oxygen carrier. In this trial, Oxycyte is being administered to hip revision surgery patients who experience mild to moderate blood loss during surgery. The safety and efficacy of Oxycyte used to prevent tissue hypoxia in these orthopedic surgical patients will be evaluated in this trial at up to six U.S. clinical sites. The company said it expects to complete this study and report its findings later this year. Based on the results from this trial, the company said it would initiate a larger Phase II trial in the same patient population.

Thoratec (Pleasanton, California) reported that a Chicago man was the first in the nation to receive the HeartMate II Left Ventricular Assist (LVAS) device in a destination therapy clinical trial. The procedure was performed March 21 by Mark Slaughter, MD, director of the mechanical assist device program at Advocate Christ Medical Center (Oak Lawn, Illinois). The HeartMate II is an implantable, continuous-flow device designed to provide long-term cardiac support for patients who are in late-stage heart failure. The national pivotal trial will determine the safety and efficacy of the device as DT in late-stage heart failure patients and will involve 200 total patients at up to 40 sites, randomizing the HeartMate II to the HeartMate XVE LVAS. Thoratec's HeartMate XVE is the only commercially available LVAS FDA-approved for DT. In a separate arm of the study, the HeartMate II will be evaluated as a bridge-to-transplant (BTT) for late-stage heart failure patients who are eligible for cardiac transplantation but in need of temporary support until a donor heart becomes available. Up to 25 sites will enroll a total of 133 patients in the BTT arm.

Toshiba America Medical Systems (Tustin, California) said it demonstrated its 64-slice cardiac computed tomography (CT) performance of the Aquilion 64 CFX at the Cardiovascular Institute of the South (CIS; Houma, Louisiana). CIS is one of the largest heart centers for nonsurgical and surgical treatment of both heart and vascular disease in the U.S.

Varian (Palo Alto, California) said its Salt Tolerant Cold Probe yields more than 20% higher sensitivity in salty samples that mimic physiological conditions. At higher salt concentrations, the sensitivity gain can be even greater, as much as 40%. The Salt Tolerant Cold Probe initially is geared for 500 MHz and 600 MHz nuclear magnetic resonance (NMR) spectrometers. The Salt Tolerant Cold Probe retains all the features and benefits of a standard cold probe, including three to four times more sensitivity than a room temperature probe. The Salt Tolerant Cold Probe and cryogenic systems are compatible with the company's new Varian NMR System and are currently available for order.

Vascular Solutions (Minneapolis) said that it has received 510(k) clearance from the FDA for its ThrombiGel hemostatic foam, a new version of its original D-Stat Dry product. The ThrombiGel version contains a gelatin foam pad (replacing the gauze pad in the original D-Stat Dry) to provide a pre-mixed, sterile, gelatin/thrombin hemostat. Two sizes of the ThrombiGel pad were included ThrombiGel and ThrombiGel XL. Both sizes can be used in a variety of medical procedures for the control of bleeding.

W. L. Gore & Associates (Flagstaff, Arizona) said it has received FDA 510(k) clearance to market the Gore Bioabsorbable Hernia Plug. The device, the first of its kind, was developed as an alternative to permanent hernia plugs. The bioabsorbable properties of the device allow it to be completely absorbed naturally by the body as the hernia defect heals. The plug's design optimizes repair time, while allowing the surgeon to quickly and easily tailor the device to fit the defect. The flexible, hollow tubes unique to the Bioabsorbable Hernia Plug fold and collapse, permitting the device to adapt to the cavity. Excess material can be trimmed away. In addition, the tubular construction serves as scaffolding for guided tissue regeneration. The plug is available with or without a permanent overlay mesh.

XDx (South San Francisco, California) has launched a test for the management of heart transplant patients in the hope that it will eliminate the need for potentially dangerous or problem-ridden biopsies, which is the current method of determining if a heart transplant patient is rejecting the donor organ. The company said the AlloMap molecular expression test is "one of the first practical applications of the Human Genome Project." The current clinical practice for monitoring heart transplant rejection is endomyocardial biopsy. That procedure requires a small sample of tissue that is clipped from the heart and then analyzed by a pathologist. With AlloMap testing, which received CLIA approval in November 2004, a clinician draws a tube of blood and sends it to the XDx reference lab. The lab provides a report to the clinician, taking about 48 hours for the whole process.