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European trends in alternate-site monitoring, disease management.
January 1, 2002... DUSSELDORF, Germany - Disease management in Europe, as in other geographic segments of the medical device market, is increasingly focusing on technologies for use in a wider array of sites, including sites outside of the traditional hospital...
Implantation devices, advances in bypass grafting draw interest.
January 1, 2002... ANAHEIM, California - New heart implantation devices and techniques for primary bypass grafting are among recent surgical advances against heart disease and have the potential to help thousands of patients each year, according to research...
Bioring SA seeking notice via pediatric heart ring device.
January 1, 2002... Doing something a little different is one way for a new company to draw some notice, and a Swiss developmental firm is starting with little children.
That's the strategy for Bioring SA (Lonay, Switzerland), a relatively new cardiovascular...
Magnetic resonance gains in cardio units. (Report from Europe).
January 1, 2002... Interventional magnetic resonance (IMR) using high-field (1.5T) is becoming a routine procedure for clinical examinations in many European cardiovascular departments. A limitation in endovascular interventions, however, has been the use of...
Cardiac Science. (Acquisitions).
January 1, 2002... * Cardiac Science (Irvine, California) completed the acquisition of Artema Medical AB (Stockholm, Sweden), a manufacturer of patient monitors and external defibrillator devices, through the issuance of about 4 million shares of common stock to...
Millennium Pharmaceuticals (Cambridge, Massachusetts) and COR Therapeutics (South San Francisco,California) (Acquisitions).
January 1, 2002... * Millennium Pharmaceuticals (Cambridge, Massachusetts) and COR Therapeutics (South San Francisco, California) have signed a definitive agreement for Millennium to acquire COR in a stock-for-stock exchange valued at $2 billion. The companies...
Novametrix Medical Systems. (Acquisitions).
January 1, 2002... * Novametrix Medical Systems (Wallingford, Connecticut) reported that it is in negotiations with what it termed "a potential acquirer" regarding a merger, with the company's common stock to be converted into common stock of the potential...
Three remain alive in AbioCor trials. (Business Developments).
January 1, 2002... At this writing, three patients remained alive and supported on the AbioCor totally implanted heart, made by Abiomed (Danvers, Massachusetts), as part of the company's FDA-approved five-patient clinical trial of the device. Shortly before this...
Guidant (Indianapolis, Indiana) has begun a strategic partnership with HeartCenterOnline (Boca Raton, Florida) under which HeartCenterOnline has created a web site for Guidant to provide hearth care information to patients and families who suffer from heart and cardiovascular disease. (Agreements).
January 1, 2002... * Guidant (Indianapolis, Indiana) has begun a strategic partnership with HeartCenterOnline (Boca Raton, Florida) under which HeartCenterOnline has created a web site for Guidant to provide hearth care information to patients and families who...
Percutaneous Valve Technologies (PVT; Fort Lee, New Jersey) and VenPro (Irvine, California) have signed a development agreement for medical devices in the field of chronic venous insufficiency (CVI). (Agreements).
January 1, 2002... * Percutaneous Valve Technologies (PVT; Fort Lee, New Jersey) and VenPro (Irvine, California) have signed a development agreement for medical devices in the field of chronic venous insufficiency (CVI). The companies will jointly develop...
MADIT II may drive post-MI use of ICDs. (Market Updates).(Multi-center Automatic Defibrillator Implantation Trial, myocardial infarction, implantable cardioverter defibrillator)
January 1, 2002... When a study reveals that a product can produce a 30% reduction in mortality as a result of sudden cardiac death (SCD), the particular subject of that trial probably has a bright future. That is the primary implication of the Multi-center...
CardioGenesis. (Personnel File).
January 1, 2002... * Janet Fauls has been named vice president of regulatory affairs and quality assurance for CardioGenesis (Foothill Ranch, California). Fauls formerly was the director of worldwide regulatory affairs for Allergan. CardioGenesis develops systems...
Data Sciences International. (Personnel File).
January 1, 2002... * H. Clark Adams has been named executive vice president of sales, marketing and business development for Data Sciences International (St. Paul, Minnesota). Most recently, Adams served as president of Entrepreneurial Management and Consulting...
Radiance Medical. (Personnel File).
January 1, 2002... * Michael Henson said in mid-December that he would step down as board chairman of Radiance Medical (Irvine, California), effective Jan. 1. Henson is a founder of both Radiance and its predecessor company, Cardiovascular Dynamics, and served as...
Sulzer Medica. (Personnel File).
January 1, 2002... * Dennis Wallach, head of the Spine Group subsidiary of Sulzer Medica (Winterthur, Switzerland), has been named to head the company's Cardiovascular Prostheses Division. Wallach replaces Terry Marlatt, who will leave the company after 14 years...
St. Jude releases its identity pacemakers. (Product Pipeline).
January 1, 2002... St. Jude Medical (St. Paul, Minnesota) received FDA approval to market the Identity pacemaker, the company's newest pacemaker product line. A limited U.S. launch of these devices has begun, with full U.S. market release scheduled for 1Q02. The...
Angiogene. (Product Pipeline).
January 1, 2002... * Angiogene (Montreal, Quebec) began enrolling patients into Beta-Impact, its Phase I/II trial for the prevention of restenosis following balloon angioplasty. This open-label trial is aimed at assessing the safety, tolerability and efficacy of...
CardioDynamics International. (Product Pipeline).
January 1, 2002... * CardioDynamics International (San Diego, California), a developer of Impedance Cardiography (ICG) technology and manufacturer of BioZ digital cardiac function monitoring systems, began the ED-IMPACT (Emergency Department IMPedance...
Cardiac Science (Product Pipeline).
January 1, 2002... * Cardiac Science (Irvine, California) was granted three additional U.S. patents related to its automatic external defibrillator (AED) products, covering the company's Powerheart technology, an external hospital monitor that provides continuous...
CardioVasc. (Product Pipeline).
January 1, 2002... * CardioVasc (Menlo Park, California) received a CE mark from TUV Product Services for its first product, the NuVasc Stent Graft. The company's technology platform incorporates patented material surface strategies that bond various compounds...
Collateral Therapeutics. (Product Pipeline).
January 1, 2002... * Collateral Therapeutics (San Diego, California) highlighted results from a review article published in Circulation Research, a journal of the American Heart Association, that provides a review of safety data from clinical trials of...
Corvas International. (Product Pipeline).
January 1, 2002... * Corvas International (San Diego, California) said results from a Phase IIa study show its anticoagulant rNAPc2 appears to be safe and well tolerated when administered to patients prior to elective percutaneous transluminal coronary...
CryoLife. (Product Pipeline).
January 1, 2002... * CryoLife (Atlanta, Georgia), a developer of cryopreserved and tissue-engineered implantable heart valves, vascular and orthopedic reconstruction grafts and surgical adhesives, reported on a study by Baylor College of Medicine (Houston, Texas)...
CV therapeutics. (Product Pipeline).
January 1, 2002... * CV Therapeutics (Palo Alto, California) said that in an open-label, dose-ranging Phase II trial in patients with atrial fibrillation or flutter, CVT-510 consistently reduced heart rate from baseline (p
Edwards lifesciences. (Product Pipeline).
January 1, 2002... * Edwards Lifesciences (Irvine, California) reported the first European implants of its next-generation Lifepath AAA Endovascular Graft system, a less-invasive option for treating abdominal aortic aneurysms (AAA), a condition that involves a...
Esperion Therapeutics. (Product Pipeline).
January 1, 2002... * Esperion Therapeutics (Ann Arbor, Michigan) reported positive preliminary findings from a Phase IIa study of ETC-588, or LUV (large unilamellar vesicles), a novel biopharmaceutical currently in development for treatment of acute coronary...
Guidant. (Product Pipeline).
January 1, 2002... * Guidant (Indianapolis, Indiana) launched its Multi-Link Tristar coronary stent system in Japan. The product is available in low profiles and includes a broad range of sizes: diameters from 2.5 mm to 4 mm and lengths ranging from 8 mm to 28...
Kensey Nash. (Product Pipeline).
January 1, 2002... * Kensey Nash (Exton, Pennsylvania) began the PRIDE (PRotection during saphenous vein graft Intervention to prevent Distal Embolization) randomized trial for its TriActiv Distal Protection System. It will take place at up to 50 sites, enrolling...
Novoste. (Product Pipeline).
January 1, 2002... * Novoste (Norcross, Georgia) received Canada Therapeutic Products Program approval to commercially market the Beta-Cath System with 30 mm, 40 mm and 60 mm radiation source train lengths and the B-Rail Delivery Catheter in Canada. Beta-Cath is...
Quinton. (Product Pipeline).
January 1, 2002... * Quinton (Bothell, Washington) released an electrocardiograph (ECG) unit, the QCG 740, a unit that acquires 10-second sections of ECG data and analyzes results for irregularities. The QCG 740 is the first product in a new family of Quinton...
Radiance Medical Systems. (Product Pipeline).
January 1, 2002... * Radiance Medical Systems (Irvine, California) enrolled the first U.S. patients in its peripheral vascular clinical study, RAPID (Radiation After PTA Is Done). The three de novo lesion cases were completed at Rush Presbyterian Hospital...
Somanetics (Product Pipeline).
January 1, 2002... * Somanetics (Troy, Michigan) received FDA clearance to market its CorRestore patch, an implant designed for use in cardiac repair and reconstruction, including surgical anterior ventricular endocardial restoration (SAVER), a treatment for...
Spectranetics (Product Pipeline).
January 1, 2002... * Spectranetics (Colorado Springs, Colorado) completed enrollment of the PELA (Peripheral Excimer Laser Angioplasty) study, which tests the use of excimer laser angioplasty to treat blocked arteries in the upper leg. The randomized trial...
Thoratec. (Product Pipeline).
January 1, 2002... * Thoratec (Pleasanton, California) received FDA approval of a supplement to its approved investigational device exemption (IDE) that enables the company to begin Phase II trials for its Aria CABG (Coronary Artery Bypass Graft). The trial is...