An article in the Aug. 19, 2000, issue of The Lancet concludes that the T-wave alternans technology from Cambridge Heart (Bedford, Massachusetts) is the most effective of seven non-invasive tests used to identify congestive heart failure (CHF) patients at risk for developing life-threatening abnormal heart rhythms. The study results suggest that the Microvolt T-Wave Alternans Test enables clinicians to identify the risk of sudden cardiac death among those CHF patients with no history or symptoms of abnormal heart rhythms. The test measures beat-to-beat fluctuations in heartbeat, called microvolt T-wave alternans, measured at one millionth of a volt. They are detected using proprietary Alternans Sensors while the heart rate is elevated by exercise, use of pharmacological agents or pacing.
Sudden cardiac death occurs at six to nine times the rate of the general population in patients diagnosed with CHF. In this study, researchers followed 107 CHF patients with no prior history of sustained ventricular arrhythmias for 18 months. Microvolt level T-wave alternans was measured non-invasively in these patients using Cambridge Heart's CH 2000 system during a standard stress test. Six other clinical measures that have traditionally been used to assess the risk of sudden death were also obtained for the patients involved in this study. Of all seven measures, microvolt T-wave alternans was the only statistically significant predictor of sudden death. Among those patients with a positive T-wave alternans test, the rate of sudden death or resuscitated life-threatening arrhythmia was 21 percent at 18 months following the test. Richard Cohen, MD, PhD, Whitaker professor in the Harvard-MIT Division of Health Sciences and Technology (Cambridge, Massachusetts) and chairman of the Cambridge Heart scientific advisory board, said that the study "demonstrates that microvolt T-wave alternans can play an important role in identifying which CHF patients will benefit from preventive therapy and which are not in need of expensive and potentially invasive therapies."
Elsewhere in the product pipeline:
- Endologix (Irvine, California) has received FDA approval to begin a Phase II human clinical trial of its PowerLink System in treating abdominal aortic aneurysms. In addition, the company has been issued two U.S. patents for its technology, covering more than 60 claims and establishing the technology as a method of manufacturing and deploying an endoluminal graft. The company has received the CE mark for the product, which is marketed in Europe by C.R. Bard (Murray Hill, New Jersey). The Endologix ELG is a fully supported one-piece abdominal aortic device developed by endovascular surgeons at the Arizona Heart Institute (Phoenix, Arizona). C.R. Bard has obtained an exclusive option to acquire all of the capital stock of the company before the end of the year at a pre-set price.
- Genzyme Surgical Products (Cambridge, Massachusetts) has launched the Genzyme Immobilizer System, the company's third-generation platform for beating-heart surgery and the next generation of Genzyme's Saph-Lite system, for minimally invasive harvesting of the saphenous vein during cardiac bypass surgery. Genzyme Surgical, a division of Genzyme General, makes devices, biomaterials and biotherapeutics for the cardiothoracic and general surgery markets and products for minimally invasive cardiovascular surgery.
- Gliatech (Cleveland, Ohio) scientists presented data at the 18th International Complement Workshop in Snowbird, Utah, indicating that an anti-complement monoclonal antibody (MoAb) reduces tissue damage in pre-clinical models of heart attack. The presence of complement components has been suggested to lead to damage to heart tissue following a heart attack. The company previously has shown that its anti-properdin MoAbs effectively block complement activation in models of cardiopulmonary bypass surgery and immune complex disease such as arthritis. In the recent study, an anti-properdin MoAb was shown to reduce the extent of myocardial tissue damage size in a pre-clinical heart attack model. This data further suggests that an anti-properdin MoAb may also have clinical utility in the treatment of other similar conditions, such as stroke. Properdin is a protein of the complement alternative pathway, which along with the complement classical pathway serves as a host immune defense system. Gliatech has developed proprietary MoAbs to properdin that are potent inhibitors of the complement alternative pathway. Thomas Oesterling, PhD, chairman and CEO of Gliatech, said that the company believes "a fully human anti-properdin monoclonal antibody will provide a therapeutic benefit in several clinical settings, such as heart attacks, stroke or arthritis."
- Guidant (Indianapolis, Indiana) reported receiving FDA clearance to market a new high-output dual-chamber defibrillation system for patients with high defibrillation thresholds. The Ventak Prizm HE provides the same small, physiologic shape and full feature set as the Ventak Prizm system, but with 41 J of stored energy. The Ventak Prizm HE device is implanted under the skin near the collarbone to continuously monitor the patient's heart rhythm and deliver therapy when needed for patients at risk of life-threatening ventricular heart rhythms. Fred McCoy, president of Guidant's Cardiac Rhythm Management group (St. Paul, Minnesota), said, "the entire Ventak family – Ventak Prizm 2, Ventak Prizm HE and Ventak Prizm – is smaller than the 40-cc benchmark, therefore, physicians are now in a position to chose the appropriate system for each patient without compromise."
- Hemosol (Toronto, Ontario, Canada) said results of its Phase III randomized, double-blind study of Hemolink, a human hemoglobin-based blood substitute, did achieve statistically significant results. The company said the product "actually worked better than we expected. It showed that Hemolink effectively reduced the number of patients who had to have donor RBCs. Of those Hemolink patients who did require donor RBC, they had to get less and get it later." In mid-June, Hemosol had said that preliminary results showed the blood substitute didn't prove Hemolink's benefits. The trial had two main purposes. The first was to determine if Hemolink could be given safely in a large number of patients undergoing routine coronary artery bypass grafting (CABG) surgery. The second was to determine whether the transfusion of donor red blood cells (RBCs) could be effectively avoided or reduced in patients given Hemolink relative to patients in a control group. Those in the control group received penaspan, a standard volume expander, instead of Hemolink. The Phase III trial involved 288 patients in Canada and the UK. The company planned to file for marketing approval in Canada in July. Approval, if granted, should take about a year. Hemosol plans to start filing for approval in select European countries in either September or October. Patients are being enrolled for a larger U.S. trial, with treatment expected to start this month. About 40 sites will participate. The trial should last about a year, with a new drug application expected to be filed with the FDA in the second half of 2001.
- Integra LifeSciences (Plainsboro, New Jersey) has launched its Brisman-Nova, Hallin and Loftus carotid endarterectomy shunts, which join the Sundt shunt to form a line of carotid shunts. A carotid endarterectomy is a surgical procedure to prevent stroke in which a surgeon removes fatty deposits from one of the two main arteries in the neck supplying blood to the brain. Integra LifeSciences, a subsidiary of Integra LifeSciences Holdings, makes medical technologies for tissue regeneration.
- Inverness Medical Technology (Waltham, Massachusetts) has received FDA clearance for a new blood glucose monitoring system featuring a 5-second test time, advanced electrochemical biosensor test strips which require a 1 microliter blood sample and the user option of finger or arm testing. It will be marketed worldwide by LifeScan, a Johnson & Johnson company. Inverness makes glucose monitoring products and systems.
- Medisys Technologies (Baton Rouge, Louisiana) has submitted a U.S. patent application for its VacuSaf blood collection safety device. VacSaf is designed to cover and protect the sharp of a blood collection needle while it is still in the vein. It uses the technology behind CoverTip, the company's safety syringe that will be introduced to the health care market this fall. The company also is filing patent applications for new safety designs in blood collection, capillary blood testing and tissue excision cutting needles.
- PLC Systems (Franklin, Massachusetts) said that the American Heart Association (AHA; Dallas, Texas) has accepted an abstract titled "Sustained Angina Relief Five Years after Transmyocardial Revascularization with a CO2 Laser." Keith Horvath, MD, assistant professor of surgery at Northwestern University Medical School (Chicago, Illinois), will present the study at the 73rd Scientific Sessions of the AHA, to be held in New Orleans in November. Mark Tauscher, president and CEO of PLC, said that the study "represents a clinical milestone, which validates the long term therapeutic benefits of CO2 TMR .... I expect these positive outcomes will assist in potential hospitals acquiring PLC's unique CO2 TMR technology."
- Texas Biotechnology (Houston, Texas) and SmithKline Beecham (London) won FDA clearance for argatroban (formerly known as Novastan), an anticoagulant for the prevention or treatment of thrombosis associated with heparin-induced thrombocytopenia (HIT), an allergic reaction caused by heparin, a common anticoagulant used to prevent blood clots. If untreated or misdiagnosed, HIT patients may develop serious complications such as pulmonary embolism (blood clot in the lungs), heart attack, limb damage requiring amputation, or death. Mortality from HIT is estimated to be as high as 30% in patients developing serious complications. The approval prompted a $7 million milestone to Texas Biotechnology from SmithKline Beecham. Argatroban is a synthetic small-molecule inhibitor of thrombin, an enzyme involved in blood clotting. It does not produce the antibodies that heparin does. Phase III trials have been completed for the use of the drug in HIT patients undergoing angioplasty, and the company said it is developing the drug as an alternative to heparin in hemodialysis, stroke and acute coronary syndrome.
- Thoratec Laboratories (Pleasanton, California) performed the first implant under its U.S. clinical trial for its Aria CABG (coronary artery bypass graft). The procedure was performed by cardiac surgeon Mark Slaughter at Christ the King Hospital and Medical Center (Chicago, Illinois). The company's AEGIS/ U.S. (AlternativE Graft Investigational Study) is designed to test the effectiveness of the Aria CABG in coronary artery bypass patients who have too few or no suitable vessels of their own. Thoratec Laboratories makes medical devices for circulatory support and vascular graft applications, all of which incorporate its proprietary biomaterial, Thoralon.
- Vasomedical (Westbury, New York) said that an analysis of data from the International Enhanced External Counterpulsation System (EECP) patient registry at the University of Pittsburgh Graduate School of Public Health (Pittsburgh, Pennsylvania) points to a sustained improvement in angina classification, as defined by the Canadian Cardiovascular Society, at six and 12 months following EECP therapy. Before treatment, 79% of the patients were categorized as having the most severe class III or class IV anginas. Among the patients evaluated at six and 12 months post-treatment, only 16% had class III or class IV anginas. The company said the results of this analysis support the findings of a five-year follow-up study published by Lawson, et al., in the April 2000 issue of Clinical Cardiology. Vasomedical makes EECP systems based on the its proprietary technology.
- VenPro (Irvine, California), a private medical device company, has launched its Contegra Pulmonary Valved Conduit valve for clinicians in all European countries that recognize CE mark approval. Contegra, which is used primarily in pediatric heart surgery to correct or reconstruct congenital malformations of the pulmonary valve and right ventricular outflow tract, received the CE mark in late 1999, and Medtronic (Minneapolis, Minnesota) distributes the device for VenPro through an international distribution agreement. "Contegra addresses a market need for a more readily available bioprosthesis for pediatric congenital heart valve surgery," said King Nelson, VenPro president and chief executive officer. "Homografts, currently considered the device of choice for this type of reconstruction, are limited by the availability of donated human organs, particularly in the small sizes used in children." Made from a bovine jugular vein containing an integral venous valve, the conduit combines features of a homograft with the convenience of an off-the-shelf product in a range of small sizes suitable for pediatric use. VenPro has launched a U.S. investigational device exemption study for the Contegra Pulmonary Valved Conduit. Other products in development include bioprostheses for the treatment of chronic venous insufficiency of the legs.
- Vital Images (Minneapolis, Minnesota) has received FDA 510(k) clearance for a new option to VScore, its coronary artery calcium scoring software. Called VScore with EKG Gate, this software uses an alternative measurement process that exposes Vital Images' calcium scoring technology to a much larger potential market, according to the company. Calcium is a primary component of arterial plaque, which can indicate the risk of serious coronary problems. VScore uses image data from electron beam computed tomography (CT) scanners, as well as image data from newer multi-slice helical CT scanners with coronary scanning capabilities. Vital Images makes 3-D imaging software for use in clinical diagnosis, surgical planning and screening applications.