CardioTech International (Woburn, Massachusetts) reported that the first two patients enrolled in the MyoLink peripheral graft clinical study had passed the three-month follow-up point with functioning grafts and relief of pre-operative symptoms. Three months' implantation with no graft problems is a clinical milestone in this type of procedure.
The patients were suffering from disabling leg pain and limited mobility. MyoLink grafts were implanted from the femoral artery to the popliteal artery. After the leg implants both patients have returned to normal conditions. MyoLink allows the transmission of pulsatile blood flow through the bypass and into the distal vessels, a feature that permits its use in smaller diameters for critical limb ischemia and claudication, according to the company.
In the U.S., critical limb ischemia is responsible for 55,000 amputations annually, mostly in diabetics. CardioTech estimates that development of a successful below-the-knee peripheral vascular graft could tap a world market estimated at over $350 million annually.
Elsewhere in the product pipeline:
ADAC Laboratories (Milpitas, California) has received FDA 510(k) clearance for Pinnacle3 Version 5.0, the latest release of its Pinnacle3 3-D radiation therapy planning software. Pinnacle3 systems assist clinicians in developing 3-D conformal radiation therapy plans that maximize the radiation dose to tumors while minimizing the dose to surrounding healthy tissues. Version 5.0 software is designed to facilitate the cancer care industry's move to electronic data transfer and management and to eliminate manual steps typically used to export data to other devices, such as record and verify systems, automated block cutting devices, and compensator milling machines. ADAC will offer an IMRT package as an add-on to the Pinnacle3 3D radiation treatment planning software. The company also said it will release its implementation of forward planning intensity modulated radiation therapy in June.
Ampersand Medical (Chicago, Illinois), a developer of point-of-care diagnostics, has begun a clinical trial of a device used to collect cells for cervical cancer screening and part of the InPath System designed to address shortcomings of the current Pap test. The trial will evaluate the collector's effectiveness compared to traditional brush/spatula collection methods. The collector is a balloon which, when inflated, conforms to the shape of the cervix and collects cells, through use of an adhesion material on its surface to provide simultaneous sampling of the entire cervix and its transition zones. The InPath System features protein-based bio-molecular markers in conjunction with laser-induced fluorescence technology to identify abnormal cervical cells.
APS (Ocala, Florida) has launched its Action Potential Simulation Therapy (APST) pain management device in the U.S. The company calls the APST system "the only electrotherapy device in the world that simulates the body's natural nerve impulses, which are also called action potentials." The system delivers an electrical current to the skin through electrodes to simulate natural nerve impulses, encouraging natural pain fighting and healing abilities. APST is thought to work by decreasing beta-endorphin levels, allowing neurohormones to work, according to APS. Treatment time is eight to 16 minutes per day. APS acquired U.S. distribution rights from the manufacturer last year.
Biomatrix (Ridgefield, New Jersey) has received FDA 510(k) approval to market HylaSine, a viscoelastic gel device that is injected into anatomical compartments of the sinus during and following sinus surgery. The system is designed to coat surgically altered tissue and inhibit intra-operative and post-operative bleeding, thus shortening rehabilitation time. Biomatrix, focuses on developing elastoviscous products made from biological polymers, called hylans, developed from hyaluronan, a ubiquitous polysaccharide of the body's intercellular matrix.
Centocor (Malvern, Pennsylvania) has introduced the first shielding needle for a fibrinolytic drug Retavase (reteplase), a heart attack treatment marketed exclusively in the U.S. Centocor will provide the shielding needles in all Retavase kits, effective May 2000. The needles feature a plastic sheath that covers the needle upon withdrawal from an intravenous line. Retavase is a clot-busting drug administered to heart attack patients via double-bolus injections
Computer Motion (Santa Barbara, California) has reported completion of the world's first series of pediatric cardiac procedures in France using the company's ZEUS system. Francois Laborde, MD, PhD, chief of cardiac surgery at L'Institut Mutualiste Montsouris Chiosy (Paris), performed seven fully endoscopic closures of the patent ductus arteriosis (PDA) with the system, the company said. The procedures were performed entirely through three incisions, each only 0.2 inches long, eliminating the need for a 4-inch to 5-inch incision that would normally be used in this procedure. Laborde reported that the patients, ranging from seven months to 24 months, were recovering quickly. Yulun Wang, PhD, founder and chief technical officer of Computer Motion, said that the procedure "marks a new application for our technology, which will provide significant benefits to patients, in this case young children."
Conceptus (San Carlos, California) has received FDA approval for a pivotal study of its STOP (Selective Tubal Occlusion Procedure) non-surgical permanent contraception device. About 400 women will be followed at 10 to 20 investigational sites in the U.S., Europe, and Australia, with 12 months of follow-up. Clinical endpoints include pregnancy prevention, safety, and comfort during and after the STOP procedure. The company expects to complete enrollment in the pivotal study by 2Q01. Assuming device approval, Conceptus plans marketing launch of the STOP device in select international markets beginning in 2001.
CryoLife (Kennesaw, Georgia) has received FDA approval to expand the Investigational Device Exemption (IDE) application for its BioGlue surgical adhesive human clinical study to include the use of BioGlue in vascular and selected cardiac repairs. BioGlue had been approved for use in an IDE clinical study as a surgical adjunct in the repair of type A aortic dissections, and the expanded study will assess the safety and effectiveness of BioGlue's ability to stop bleeding in cardiac and vascular procedures. The study will involve about 160 patients and is expected to be completed by year's end. BioGlue is distributed in 35 countries outside the U.S. for application in vascular and pulmonary repair.
Endius (Plainville, Massachusetts) has received FDA 510(k) clearance to market the Endius TriFix thoraco-lumbar pedicle screw system. The system uses a Dome screw design, and variable offset standard and Diamond connectors create a polyaxial system that enables conformance to natural anatomical structures of the spine while achieving a stabilized motion segment, according to the company. Pending FDA approval, TriFix will be combined with Endius' proprietary spinal endoscopic technology to reduce the invasiveness of fusion surgery. Endius will market TriFix through a 90-person spinal surgery sales force at 25 distributorships. Endius specializes in minimally invasive spine systems and surgical techniques.
EOS (Camarillo, California), a developer of ultra-miniature, high-efficiency power supplies, has introduced what it calls "the world's smallest and most efficient medically certified 80-watt AC/DC switching power supply." The MVLT80 Series of open-frame switching power supplies is certified for use in non-patient-connected medical applications; it can power a wide range of medical electronic equipment, including hospital data and health care information systems, touch screen displays, dental equipment, outpatient equipment, laboratory and analysis systems, and research equipment. Producing 5.3 watts per cubic inch in a 3-inch x 5-inch x 1-inch footprint, the MVLT80 delivers 80-watts of output power with up to 85% or better efficiency, compared to the industry norm of 68% to 72% power conversion efficiency.
Epitope (Beaverton, Oregon) has filed an Investigational Device Exemption (IDE) with the FDA for HIV testing using the OraQuick device, designed to use either an oral fluid or a blood sample to test for HIV within 20 minutes. The IDE application calls for testing of about 7,000 samples at approximately 10 sites in the U.S. The company expects IDE approval and the initiation of clinical trials during 2Q00. Epitope also said that the Centers for Disease Control and Prevention (CDC; Atlanta, Georgia) has been evaluating OraQuick for HIV testing by using CDC performance panels and, to date, the sensitivity and specificity has been 100%. Further CDC testing of OraQuick is being conducted in both Botswana and Los Angeles, and the company said it will begin studies over the next five months in Thailand, Uganda, and the Ivory Coast.
Equidyne (San Diego, California) reported the filing of a U.S. patent application for a single-use, disposable, needle-free injector incorporating the company's needle-free ampule technology contained in a disposable device about the size of a ballpoint pen. The INJEX device will compete in a $2 billion needle syringe market and is set for commercial introduction before the end of the year. J. Randall Nelson, company president and CEO, cited "a variety of compelling applications for the new INJEX disposable system, including heparin injections for post-surgical patients and outpatient treatment in oncology, both of which will reduce overall costs by minimizing hospital stays and/or clinic visits."
Genzyme Surgical Products (Cambridge, Massachusetts) has received FDA clearance to market Sepramesh Biosurgical Composite for use in hernia repair procedures. Sepramesh is a prosthetic surgical mesh designed to be sutured in place along the abdominal wall to support and strengthen hernia repairs.
Gliatech (Cleveland, Ohio) reported that the FDA has agreed to review ADCON-P under the premarket approval application (PMA) "modular review" process, permitting staged submissions and review of the PMA. Gliatech's ADCON-P is a resorbable, carbohydrate polymer liquid designed to inhibit post-surgical scarring and adhesions following gynecological pelvic surgery. The company is conducting a pivotal trial of the product at approximately 20 sites, following more than 200 patients undergoing minimally invasive gynecological surgery.
Results of a preclinical ventriculocoronary artery bypass (VCAB) revascularization procedure, developed by HeartStent (Minneapolis, Minnesota), have been published in the March 2000 edition of The Heart Surgery Forum. HeartStent's approach is to supply blood to a coronary artery directly from the left ventricle of the heart by placing a proprietary device through the ventricular wall and then into the coronary artery, thus eliminating the surgical procedure to harvest arteries or veins. John Schorgl, company president and CEO, said, "Acceptance of the HeartStent procedure by the rigorous standards of a peer review board substantiates our scientific approach and physician interest in our early pre-clinical results." The company reports having 10 issued or allowed U.S. and foreign patents covering the procedure and numerous patents pending.
Integrated Surgical Systems (Davis. California), a developer of image-directed, robotic products for surgery, reported successful performance of the first robotic total knee replacement surgery with its Robodoc Surgical Assistant System. The robotic total knee arthroplasty (TKA) was performed at Berufsgenossenschaftliche Unfallklinik (Frankfurt, Germany) by Prof. Borner, chief medical director. Borner said, "From planning, to cutting, to alignment – all went so smoothly that the total time to perform the TKA was approximately similar to the conventional method."
Mallinckrodt (St. Louis, Missouri) has received FDA 510(k) clearance to market its GoodKnight 418A and GoodKnight 418P continuous positive airway pressure (CPAP) systems for the treatment of sleep apnea. The GoodKnight 418G system has been sold in the U.S. since August 1999. The complete line of GoodKnight 418 therapeutic systems has been sold successfully in Europe since the spring of 1999. The new-generation GoodKnight 418A/418P are automatically adjusting positive airway pressure systems (autoPAP) that treat obstructive sleep apnea patients The GoodKnight 418A is designed to increase compliance and enhance patient follow-up. The GoodKnight 418P features an autoPAP function which analyzes and treats sleep-disturbed breathing.
STAAR Surgical (Monrovia, California) said it has received FDA approval of its Collamer intraocular lens (IOL) used in cataract surgery. Last year the Collamer IOL received both Health Canada approval and the European CE Mark. Collamer is a material proven to be extremely biocompatible with ocular tissue. IOLs are used to replace the natural crystalline lens of the eye when it becomes clouded or opacificated from cataracts. The foldable Collamer IOL allows for corrections between -4 and +33 diopters, and the company says it is the only IOL that varies in length to accommodate the natural shape of the human eye. A total of 686 lenses were implanted as part of the study concluded in 1998 under an investigational device exemption.
Sulzer Medica (Winterthur, Switzerland) reported launch of its Collagen Meniscus Implant (CMI), its first biological implant to be marketed in Europe. CMI, is the first product to regenerate defects of the meniscus, the crescent-shaped cartilaginous structure located in the knee joint. CMI was developed in collaboration with ReGen Biologics (Redwood, California), receiving CE market clearance this past February. Sulzer has a minority holding in ReGen and has the worldwide marketing and distribution rights outside the U.S. for CMI. The implant consists of a sponge-like structure of highly purified collagen, implanted arthroscopically to replace the damaged meniscus tissue, with the porous structure of the CMI serving as a scaffold to support in-growth of cells and the formation of new meniscus tissue.
Vasomedical (Westbury, New York) reported that long-term results of enhanced external counterpulsation (EECP) therapy are similar to results reported in contemporary surgical bypass and angioplasty trials. These results come from a study, "Long-term prognosis of patients with angina treated with enhanced external counterpulsation: Five-year follow-up study," published in the April issue of Clinical Cardiology. The study tracked the occurrence of major adverse cardiovascular events in the first 33 patients with coronary artery disease treated with EECP therapy at the State University of New York Health Sciences Center (Stony Brook, New York). Responders to EECP therapy, as indicated by improvement in stress perfusion imaging, comprised 79% of the group, with 21% not responding. Subsequent major adverse cardiovascular events, including myocardial infarction, bypass surgery, angioplasty, and death, were significantly less frequent in the EECP therapy responder group than in the non-responder group. The five-year survival rate of the 33 noninvasively treated EECP patients in the study was 88%, similar to rates reported in contemporary surgical bypass and angioplasty trials, despite the fact that many of the EECP therapy patients had already failed revascularization attempts.
Xillix (Richmond, British Columbia, Canada) said that it is developing a new platform for its fluorescence endoscopy technology, Onco-LIFE, expected to result in a new fluorescence endoscopy video system for the detection and localization of early cancer in the lung and gastrointestinal tract. The system will have a compact, modular, and lower-cost design and incorporate advanced imaging technology to provide both white light and fluorescence imaging capabilities. Onco-LIFE will feature a smaller, more maneuverable LIFE camera, allowing a physician to switch rapidly between white light and fluorescence imaging modes, with greater discrimination between normal tissue and tissue suspicious for cancer when viewing LIFE images. It will be compatible with a broad range of endoscopes, according to Xillix.
Zeiss Humphrey Systems (Dublin, California) has received FDA approval for its Zeiss Visulas 690s Laser for the activation of Visudyne (verteporfin for injection) therapy to treat wet age-related macular degeneration (AMD), the leading cause of blindness among people older than 50 years of age. The Zeiss Visulas 690s Laser activates Visudyne for the treatment of wet AMD, and was the only commercially produced laser used in the Visudyne Phase III clinical trials. The FDA has approved Visudyne therapy specifically for the treatment of AMD in patients with predominantly classic subfoveal choroidal neovascularization. Zeiss Humphrey Systems and its parent company, Carl Zeiss, makes a wide variety of instruments for use in retinal imaging, laser surgery, and glaucoma.