Edwards Lifesciences (Irvine, California) said late last month that it had received FDA 510(k) clearance for U.S. marketing of its Vantex Central Venous Catheter, which it said is the first such catheter made with an antimicrobial polymer material. Edwards said Vantex is the only central venous catheter made with Oligon, which has demonstrated broad-spectrum effectiveness against bacteria, fungi, and strain-resistant microorganisms, a source of post-operative and hospital-acquired infections.

Oligon is not a coating, but instead is integral to the polymer of the Vantex CVC, providing antimicrobial activity throughout both the inner and outer surfaces of the catheter. It produces an electrochemical response within the patient's body, releasing silver ions from the catheter's surfaces and killing bacteria that can gather there. The Vantex is available in multiple catheter sizes and two-, three-, and four-lumen configurations.

Elsewhere in the product pipeline:

Agilent Technologies (Andover, Massachusetts) has introduced a line of lightweight, portable, stand-alone patient monitors, as part of what it calls "a new focus on lower-acuity care settings." The Agilent A1 and Agilent A3 monitors provide noninvasive patient data, particularly for settings where clinicians perform procedures using conscious sedation. The new line complements the recent upgrades of the Agilent M3 and Agilent M4 patient monitors that communicate wirelessly with the Agilent Information Center. The A1 monitor provides up to three measurements: SpO₂, noninvasive blood pressure, and ECG. The A3 provides a broad set of noninvasive parameters including SpO₂, noninvasive blood pressure, ECG, respiration, and temperature. Agilent has formed an agreement with Analogic (Peabody, Massachusetts) to manufacture and distribute the monitors.

Boston Scientific (Natick, Massachusetts) has received CE mark approval of its GDC Tri-Span Coil, used to treat complex brain aneurysms and featuring a design that permits treatment of difficult shapes and sizes of aneurysms by helping to contain other GDC (Guglielmi Detachable Coil) coils within the aneurysm sac. Placed at the aneurysm opening, the GDC Tri-Span Coil acts as a scaffold to contain subsequently placed GDC coils. More than 112,000 patients will be diagnosed with a brain aneurysm this year. GDC coils are designed to reduce the likelihood of an aneurysm rupturing and causing a stroke and offer an alternative to craniotomy for repair of their brain aneurysms, a procedure requiring removal of a portion of the skull and a long hospital stay.

Corvas International (San Diego, California) said enrollment has been completed in the Phase II dose-ranging trial of its injectable anticoagulant, rNAPc2, for the prevention of deep vein thrombosis in orthopedic surgery patients. Preliminary analysis of the data indicates that rNAPc2 meets efficacy and safety expectations when compared to a contemporary historical control with low-molecular-weight heparin. The fully analyzed data will be released later this year.

Cardiac Pathways (Sunnyvale, California), a maker of cardiac mapping and ablation technology, relaunched in Europe its Realtime Position Management (RPM) Tracking System and Chilli RPM cooled ablation catheters. The company launched the FDA-approved products in the U.S. in May at the North American Society of Pacing and Electrophysiology annual meeting in Washington. The RPM system integrates real-time, 3-D catheter navigation with ablation technology to assist physicians in manipulating catheters within the heart during procedures without the aid of fluoroscopy. The Chilli Cooled Ablation System uses closed-path fluid circulation to control the catheter tip temperature during ablation to deliver energy to ablate cardiac tissue responsible for the arrhythmia.

Chase Medical (Dallas, Texas), a private company making cardiac surgical devices, introduced the epRetract retracting stabilizer for "beating heart" surgery at the American Association of Thoracic Surgeons meeting in Toronto. The stabilizer enables bypass surgery on difficult-to-reach coronary arteries and on arteries hidden by a layer of epicardial fatty tissue or coronary perfusion during the surgical procedure.

Connetics (Palo Alto, California) presented animal data on relaxin at the Wound Healing Society meeting in Toronto. The data suggest that the product could be an effective treatment for non-healing ulcers by helping improve blood flow to oxygen-deprived tissue. Relaxin is a naturally occurring human hormone with antifibrotic, angiogenic and vasodilatory properties. The product is in a pivotal trial for scleroderma, with data slated for release this fall.

CryoCath Technologies (Kirkland, Quebec, Canada) reported the results of the first four patients treated with its Frostline Linear Cryoablation System for atrial flutter at the Montreal Heart Institute (Montreal, Quebec). The procedures, using a percutaneous cryoablation catheter, resulted in the successful acute termination of the arrhythmia in three out of four patients. The 7 Fr Frostline system allows a physician to make 25 mm-long cryolesions, reducing the need to perform multiple focal ablations. The trial is designed to enroll up to 12 patients by the end of this summer, and the results will form the basis of Canadian and European regulatory applications for commercialization.

Exactech (Gainesville, Florida), a maker of orthopedic joint implants, has received FDA marketing clearance for its AcuMatch L Series Cemented Femoral Stem Component. The company calls it "the next component in what will be a full range of hip products to meet specific patient needs," and the first part of an integrated AcuMatch Hip System to be rolled out by year-end. The L Series prostheses provide primary hip stem components for use in selected international markets, and the AcuMatch L Series shares the instrument set used by Exactech's AcuMatch Integrated Hip System.

FAS International (Calgary, Alberta, Canada) reported the launch of clinical studies designed to evaluate a number of applications for the FAS Endoluminal Brush, specifically investigating its use in conjunction with a rapid test. The rapid test program will start this month and take about 12 months to complete. One study, titled "Infectious complications of Groshung catheters and the use of endoluminal brushing," will be the first prospective study on long-term catheters and will include cancer, AIDS and long-term parenteral nutrition patients. Another study is a nurse-led project using the brush for the monitoring of hemodialysis catheters. A French multicenter study is comparing the use of the brush with the use of urokinase as a first-line treatment for catheter dysfunction. FAS International develops medical devices and diagnostic tests.

Iridex (Mountain View, California) reported that a study presented at the annual meeting of the Association for Research in Vision and Ophthalmology concluded that eyes that responded to a grid infrared (810 nm) diode laser treatment using the company's laser system showed a reduced incidence of progression from dry AMD to the more vision-threatening wet form. R. Joseph Olk, MD, reported on the four-year pilot study, which included 229 eyes of 152 patients with dry AMD, randomized to either receive a single treatment with the company's IRIS Medical OcuLight SLx infrared laser photocoagulator or a control group of eyes simply observed. The data confirmed that the accumulated deposits (drusen) associated with the early stages of dry AMD were significantly reduced following a single treatment in 78% of the eyes compared to 8% of observed eyes. It also indicated that of the 35 eyes that progressed to wet AMD, 34 were either in the observation group or non-responders to treatment. Dry AMD patients with bilateral soft drusen represent a majority of all new AMD cases, and stopping AMD at the dry stage would lessen the cases of severe vision loss, according to Iridex.

Mallinckrodt (St. Louis, Missouri) and Data Critical (Redmond, Washington) introduced the Nellcor Intouch, a remote oximeter alarm notification system, during the American Association of Critical Care Nurses' National Teaching Institute. Intouch is designed to provide low-cost alarm notification of nursing staff with a paging system and incorporates radio transmitters and software designed by Data Critical. Standard alpha numeric pagers worn by clinical staff receive oximeter alarms, with pagers activated within seconds. When activated, the pager displays the bed number, alarm message, SpO₂ value, and pulse rate. Up to six systems of 24 beds can be installed in a facility, providing remote alarm notification for up to 144 patients. The Intouch system will be available beginning this month.

Medtronic (Minneapolis, Minnesota) rolled out its Spring Quattro Model 6944 quadripolar defibrillation lead at last month's Cardiostim 2000 meeting in Nice, France. The product is the latest in Medtronic's family of Sprint leads designed for transvenous use with implantable systems that monitor the electrical conduction system of the heart and deliver precisely programmed electrical impulses intended to correct dangerously rapid rhythms. The new lead is available in Europe, the Middle East, and Africa, and it is currently under investigational study in the U.S. The lead is designed for optimum sensing and defibrillation capabilities and features bipolar sensing with dual defibrillation coils in the smallest quadripolar lead body available. Maneuvered through veins to precise locations in the heart, transvenous electrical leads must deliver energy reliably while flexing every time the heart beats. The Model 6944 lead features four electrodes along its length, two dedicated to pacing and sensing the heart's electrical signals and two for delivering energy to the heart's inner surface. The new, higher-impedance Haloe tip electrode, with average impedance values between 750 ohms to 800 ohms and steroid delivery, is designed for improved system efficiency with low pacing thresholds.

Palomar Medical Technologies (Burlington, Massachusetts) has received clearance from the FDA to sell and market the Palomar SLP1000 (super long-pulse), a diode laser system that removes unwanted hair from all skin types, including tanned skin. Until recently, treatment of dark skin was marginally safe or ineffective. The SLP1000 also was cleared for treating vascular and pigmented lesions, facial, spider, and leg veins and other dermatological conditions. The system uses a combination of super long-pulse, three-phase contact cooling, photon recycling and other patented technology, and it is smaller and lighter than most current systems. The SLP1000 was developed through a cooperative research activity between Palomar and the Wellman Laboratories of Photomedicine at Massachusetts General Hospital (Boston, Massachusetts).

Qualigen (Carlsbad, California), formerly Qualisys Diagnostics, reported launch of its FastPack System, a proprietary, point-of-care, fully automated blood testing system designed to perform quantitative immunoassay tests in physicians' offices and small laboratories. The initial test available on the FastPack is total prostate specific antigen (Total PSA), a blood test for prostate cancer. Two other prostate cancer related diagnostic tests, free prostate specific antigen (Free PSA) and testosterone, are scheduled for introduction later this year. The multi-chambered disposable plastic test pack contains all of the chemical reagents needed for a single test. Other components include a diagnostic analyzer and single-use, disposable test packs. The operator inserts the patient's blood sample into the disposable test pack, loads the pack into the analyzer, and the system completes the test, with results available in 15 minutes.

Quest Medical (Allen, Texas), a subsidiary of Atrion, has received FDA 510(k) approval for its Quest MPS Myocardial Protection System for use in beating heart coronary artery bypass surgeries. The approval extends the intended use of the Quest MPS to include a new technique developed by a research team at Emory University and Crawford Long hospitals (both Atlanta, Georgia). Named PADCAB, for Perfusion Assisted Direct Coronary Artery Bypass, the technique is used to sustain a medicated blood flow to the heart during off-pump beating heart surgery, assuring adequate nourishment and protection during the procedure. The technique also enables testing of the coronary graft conduits and anastamosis for patency and physical integrity, improving the quality of the bypass graft. Emile Battat, chairman and president of Atrion, said that "the PADCAB bypass graft delivered with the Quest MPS makes possible selective perfusion of grafted vessels, resulting in faster recovery from ischemia and

greater flexibility in graft sequencing." The Quest MPS is designed to give the perfusionist independent control of the amount of arrest agent and drugs delivered with the patient's own blood, eliminating cardioplegia- induced hemodilution and reducing the volume of water exposed to the heart.

Rehabilicare (New Brighton, Minnesota) has received a U.S. patent titled "Device Using both HVPC and NMS Electrotherapy," covering a technology used in the company's Ortho Dx portable, dual-purpose neuromuscular stimulator device. The device requires a prescription from a physician and is designed to help patients achieve their therapy goals faster and more comfortably. It uses two proven modalities to aid in reducing pain and swelling while enhancing muscle contractions in treating knee and shoulder joint injuries assisting healing following arthroscopic and anterior cruciate ligament surgeries, among other disorders. Used in the homes, the device features color-coded lead wires and electrodes for easy set-up and use and combines two clinical modalities into one portable, easy-to-wear package. The dual currents allow for faster recovery time and may be preprogrammed to aid in comfort. Rehabilicare is focused on developing electromedical pain management and rehabilitation products and services used for clinical, sports medicine, home health care and occupational medicine applications.

Somanetics (Troy, Michigan) said that a 156-patient study by the Weill Medical College (New York) of Cornell University demonstrated that cardiac surgery patients with low regional brain blood oxygen saturation before surgery, as monitored by the company's INVOS Cerebral Oximeter, are more likely to suffer post-operative frontal lobe and cognitive dysfunction after their surgery. The study also demonstrated that the presence of low regional brain blood oxygen saturation before this surgery is associated with prolonged intensive care unit and hospital stays. The study was presented by Fun-Sun Yao, MD, professor of anesthesia at Cornell, at the Society of Cardiovascular Anesthesiologists' annual meeting.

Sonus Pharmaceuticals (Bothell, Washington) said the FDA has accepted as complete for review the company's response to the agency's March action letter on EchoGen (perflenapent injectable emulsion), Sonus's first product. The March letter requested a reanalysis of certain data and follows an approvable letter received by the company in April 1999. The FDA has indicated that it will complete its review of Sonus's response by the end of October. Michael Martino, company president and CEO, said, "We had hoped that the FDA would assign a shorter review time for our response. However, we believe that we have addressed the issues raised by the FDA in the March letter, and we intend to work closely with the agency in its review of our response. We continue to believe in the opportunities for EchoGen and FDA approval remains a key objective." EchoGen is an ultrasound contrast agent designed for use in echocardiography to improve the assessment of the left ventricle, the main pumping chamber of the heart.

Venetec International (San Diego, California) reported that in research conducted at Kaiser Sunnyside Medical Center (Clackamas, Oregon), unscheduled restarts for patients with peripherally inserted central catheters (PICCs) were virtually eliminated when StatLock securement devices were added to the catheter securement protocol. Steve Bierman, MD, CEO, and medical director of Venetec, said, "Replacing tape or suture with a catheter securement device spares these patients – many of them elderly – the need for multiple needlesticks, repeat doctor and nurse visits, transportation to and from a nursing home, and other difficulties associated with catheter dislodgements and unscheduled restarts." Kaiser Sunnyside had experienced 49 unscheduled restarts on a total of 496 PICCs placed during 1998, using its previous method of securing PICCs with an occlusive dressing and Steristrips. When StatLock was added, the facility's unscheduled restarts dropped to just one during 1999, from a total of 633 PICCs. StatLock securement devices feature molded plastic, adhesive-backed disks with integrated catheter anchors that are placed on the skin to firmly hold a catheter in place. Clinical studies have shown the devices reduce overall catheter-related complications up to 69%.