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Device developments are part of changing heart disease strategies.
November 1, 2001... Treatment of coronary artery disease has typically involved a choice among the three primary therapeutic modalities: Medical therapy, percutaneous intervention or coronary artery bypass surgery. Medical therapy, involving lifestyle changes as...
New technology comes to U.S. impedance cardiography market.
November 1, 2001... With the exploding interest in impedance cardiography (ICG) for the noninvasive tracking of patients' hemodynamic parameters, including cardiac output, stroke volume and systemic vascular resistance, market leader CardioDynamics International...
Study of stent coating drug release is funded. (Report from Europe).
November 1, 2001... The European Commission (Brussels, Belgium) has awarded a $1.5 million contract to investigate controlled drug delivery from implants including vascular stents. The European Union (EU) multinational contract has been won by a group of companies...
Protein C concentrate cleared.
November 1, 2001... Baxter International (Deerfield, Illinois) said that the European Medicines Evaluation Agency (London) has issued market authorization for Ceprotin protein C concentrate for use as a replacement therapy for treatment of life-threatening blood...
AF cryoablation launch eyed.
November 1, 2001... CryoCath Technologies (Kirkland, Quebec), which already markets its Freezor cryoablator for tachyarrhythmia treatment in Europe, has signed a five-year marketing agreement with Endocare (Irvine, California) for a line of cryosurgical probe...
Tissuemed gets CE mark for sealant patches.(Tissuepatch V)
November 1, 2001... Tissuepatch V is a contact-adhesive pliable film developed by Tissuemed (Leeds, England) for use in vascular or cardiac surgery. The product, made from porcine albumin, polymers and elastomers, is absorbed in about 30 days after application and...
Actelion starts dosage studies for Veletri.
November 1, 2001... Actelion (Allschwil, Switzerland) has begun new clinical trials to establish optimal dosage levels for its Veletri (tezosentan) drug for treatment of patients with acute cardiac insufficiency. Tezosentan is an intravenous dual Endothelin...
Contrast agent doesn't infringe patent.(Imavist developed by Alliance Pharmaceutical and Schering doesn't infringe on perfluorohexane microbubble usage patent)
November 1, 2001... The Imavist cardiac ultrasound imaging contrast agent, jointly developed by Alliance Pharmaceutical (San Diego, California) and Schering (Berlin, Germany), uses perfluorohexane (PHF) microbubbles to improve the quality of cardiac imaging.
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MedCath. (Acquisitions).(acquires majority interest in the Heart Hospital of New Mexico)
November 1, 2001... * MedCath (Charlotte, North Carolina) said it acquired a majority ownership interest in the Heart Hospital of New Mexico (Albuquerque, Mexico). The 55-bed hospital opened in October 1999 with a shared ownership structure that included MedCath,...
NMT Medical. (Acquisitions).(to sell vena cava filter business assets to C.R. Bard)
November 1, 2001... * NMT Medical (Boston, Massachusetts) said it has signed an agreement to sell assets comprising the company's vena cava filter business to C.R. Bard (Murray Hill, New Jersey). In exchange for these assets, NMT will receive $27 million in...
Thermo Electron. (Acquisitions).(Viasys Healthcare approved as spin-off)
November 1, 2001... * Thermo Electron (Waltham, Massachusetts) said its board of directors approved the spin-off of the company's wholly owned Viasys Healthcare (Philadelphia, Pennsylvania) subsidiary as a dividend to Thermo Electron shareholders. Thermo Electron...
AbioCor implants are 3rd and 4th in trial. (Business Developments).(Abiomed artificial heart implant trials)
November 1, 2001... Continuing its policy of little fuss and less fanfare, Abiomed (Danvers, Massachusetts) reported two more implants of its AbioCor artificial heart, in late September and mid-October, without releasing many details about the procedures or the...
Medtronic laying off 450. (Business Developments).(at Medtronic/AVE plant)
November 1, 2001... Medtronic (Minneapolis, Minnesota) said in late October that it will lay off 450 workers at its Medtronic/AVE plant in Santa Rosa, California, those cutbacks forced by a court ruling that resulted in halting sales of its rapid-exchange balloon...
Kensey Nash.(receives research award from National Institute of Standards and Technology ATP program)
November 1, 2001... * Kensey Nash (Exton, Pennsylvania) reported receiving a $1.9 million award through the National Institute of Standards and Technology ATP program for a three-year effort to develop a synthetic small diameter vascular graft. In collaboration...
Progenics Pharmaceuticals.(receives grant from the National Institutes of Health)
November 1, 2001... * Progenics Pharmaceuticals (Tarrytown, New York) received about $300,000 from the National Institutes of Health (Bethesda, Maryland) as a Phase I Small Business Innovation Research grant. The grant is for the development of dehydroascorbic...
Somanetics. (Agreements).(enters agreement with Perfusion Resources Network for the distribution of the Invos Cerebral Oximeter patient monitoring system)
November 1, 2001... * Somanetics (Troy, Michigan) has entered into a distribution agreement for its Invos Cerebral Oximeter patient monitoring system with Perfusion Resources Network (PRN), a Texas-based cardiopulmonary product management company. Through its...
Sports driving next big surge in AEDs. (Market Updates).(Philips Medical Systems Inc. reports that sports facilities are beginning to install automatic external defibrillators)
November 1, 2001... Airlines and gambling casinos were among the first industries to realize the value of automatic external defibrillators (AEDs), and sports -- whether the spectator variety or actively pursued -- may be offering the next large wave of...
Study sees decline in heart disease. (Market Updates).
November 1, 2001... American adults are leading healthier lives and thus are significantly reducing their risk of heart disease mortality, according to a new University of California, San Francisco (UCSF; San Francisco, California) study published in the Oct. 1...
Arrhythmia Research Technology.(appoints James Rouse president and chief operating officer)
November 1, 2001... * James Rouse has been appointed president and chief operating officer of Arrhythmia Research Technology (Fitchburg, Massachusetts). Rouse was named president of Micron Products, a wholly owned subsidiary of Arrhythmia, earlier this year...
Boston Medical Technologies.(appoints Bradford Gay president and chief executive officer)
November 1, 2001... * Bradford Gay has been named president and chief executive officer of Boston Medical Technologies (Wakefield, Massachusetts), replacing John Schafer, who will continue to serve the company in a consulting role. Boston Medical is the developer...
CardioTech International.(appoints Bruce MacKinnon manager of new business development; Ricci Smelser appointed engineering manager)
November 1, 2001... * Bruce MacKinnon has been appointed manager of new business development at CardioTech International (CDT; Woburn, Massachusetts). In a related move, Ricci Smelser has been promoted to the new position of engineering manager. MacKinnon has held...
Edwards Lifesciences.(Keith Reisinger, Todd Abraham, appointed vice presidents)
November 1, 2001... * Keith Reisinger has been named corporate vice technology, at Edwards Lifesciences (Irvine, California). Additionally, Todd Abraham has been named vice president, manufacturing. Reisinger most recently served as vice president and chief...
Ischemia Technologies.(Donna Edmonds appointed senior vice president of sales and marketing)
November 1, 2001... * Donna Edmonds has been named senior vice president of sales and marketing at Ischemia Technologies (Denver, Colorado). Most recently, Edmonds was with Spectral Diagnostics, where she was responsible for launching that company's Cardiac STATus...
Medtronic.(appoints Stephen Oesterle senior president of medicine and technology)
November 1, 2001... * Stephen Oesterle, MD, has been named senior president of medicine and technology for Medtronic (Minneapolis, Minnesota). Oesterle will join the company in January 2002 and succeed Glen Nelson, MD, who is retiring next March. Oesterle is...
Scios.(promotes Matthew Hooper to vice president, counsel)
November 1, 2001... * Matthew Hooper was promoted to vice president, counsel, of Scios (Sunnyvale, California). He replaces John Newman, who has retired after serving as general counsel since 1983. Hooper has been the senior patent counsel handling all...
Zoll Medical.(appoints Patrick Nestor general manager)
November 1, 2001... * Patrick Nestor has been appointed general manager for first responder and public access defibrillation at Zoll Medical (Burlington, Massachusetts). Most recently, Nestor was director of sales for CAS medical Systems. Zoll makes noninvasive...
Thoratec IVAD in 1st implant in Europe. (Product Pipeline).(Implantable Ventricular Assist Device)
November 1, 2001... Thoratec (Pleasanton, California) reported a 63-year-old German man suffering from heart failure has become the first patient implanted with the company's Implantable Ventricular Assist Device (IVAD). It said this marks the first time a patient...
Alteon. (Product Pipeline).(releases preclinical study results for ALT-711)
November 1, 2001... * Alteon (Ramsey, New Jersey) said an academic team has released results of a preclinical study that demonstrated the ability of ALT-711 to decrease the thickening of the heart that may occur as a result of hypertension, and to improve the...
AngioDynamics. (Product Pipeline).(introduces 4 Fr Uni*Fuse thrombolytic infusion catheter)
November 1, 2001... * AngioDynamics (Queensbury, New York), an E-Z-EM subsidiary, introduced its 4 Fr Uni*Fuse thrombolytic infusion catheter. Infusion ports of the catheter are pressure-responsive slits instead of side holes, with infusion lengths of 5 cm, 10 cm...
Cardima. (Product Pipeline).(reports progress on Revelation Helix radiofrequency ablation microcatheter testing)
November 1, 2001... * Cardima (Fremont, California) reported progress of its multicenter study for treating atrial fibrillation (AF) originating in the pulmonary veins of the heart. Four trial patients in the second study were treated with the company's Revelation...
Cardio-optics. (Product Pipeline).(completes Trans Blood Vision System experiments)
November 1, 2001... * Cardio-optics (Boulder, Colorado) completed a six-week series of experiments of its patented Trans Blood Vision System, verifying that the technology can see through flowing blood. This represents a major breakthrough for surgical procedures...
CryoCor. (Product Pipeline).(patient enrollment completed for CryoCor Cardiac Cryoablation System clinical trial)
November 1, 2001... * CryoCor (San Diego, California), a development-stage medical technology company, said that patient enrollment has been completed in the first clinical trial of the CryoCor Cardiac Cryoablation System for the treatment of atrial fibrillation...
CV Therapeutics. (Product Pipeline).(offers heart disease information web site focusing on chronic angina)(LifeHeart.com)
November 1, 2001... * CV Therapeutics (Palo Alto, California) launched LifeHeart.com, a heart disease information web site with special focus on chronic angina. LifeHeart.com provides user-friendly content and information to help patients cope with the daily...
Endocardial Solutions. (Product Pipeline).(releases upgraded version of Precision software for use in the EnSite 3000 System)
November 1, 2001... * Endocardial Solutions (St. Paul, Minnesota) was granted FDA clearance to release Precision, an upgraded version of the company's software product for use in the EnSite 3000 System for diagnostic mapping of complex arrhythmias. The FDA cleared...
Endologix. (Product Pipeline).(submits stent graft trial results to Japan's Ministry of Health, Labor, and Welfare)
November 1, 2001... * Endologix (Irvine, California) has submitted to the Japanese Ministry of Health, Labor and Welfare the results from a multicenter trial investigating the efficacy of its stent graft for the treatment of aortic aneurysms. Endologix said it is...
Florence Medical. (Product Pipeline).(receives marketing clearance for its SmartFlow Multiple Lesion device)
November 1, 2001... * Florence Medical (Wellesley, Massachusetts) received FDA clearance for SmartFlow Multiple Lesion, a device that provides real-time blood flow data to use in assessing the severity of multiple stenotic lesions during cardiac catheterization...
Guidant. (Product Pipeline).(introduces Acculink Carotid Stent System in Europe)
November 1, 2001... * Guidant (Indianapolis, Indiana) launched in Europe the Acculink Carotid Stent System for the treatment of carotid artery disease. Patients may be at risk for stroke if particles of atherosclerotic plaque are dislodged from the carotid artery...
LuMend. (Product Pipeline).(receives European CE marketing approval for Frontrunner CTO Catheter)
November 1, 2001... * LuMend (Redwood City, California) reported receiving CE mark approval for its Frontrunner CTO Catheter in Europe. CTOs, or chronic total occlusions, are complete blockages in the coronary arteries. The Frontrunner is designed to provide an...
Medtronic. (Product Pipeline).(reports implantation of first Marquis DR Model 7274 cardioverter-defibrillator)
November 1, 2001... * Medtronic (Minneapolis, Minnesota) reported the implantation of the first of its Marquis DR Model 7274 cardioverter-defibrillators, the initial product in the company's next generation of ICDs, in a 76-year-old man last month at the State...
Micro Therapeutics. (Product Pipeline).(reports Onxy liquid embolic material is successful for the treatment of pre-stroke conditions)
November 1, 2001... * Micro Therapeutics (MTI; Irvine, California) said its flagship product, Onyx, a treatment for conditions that can lead to stroke, and related products were presented and demonstrated in two successful live cases to interventional...
Sutura. (Product Pipeline).(to market 6F SuperStitch vascular suturing device)
November 1, 2001... * Sutura (Fountain Valley, California) reported receiving 510(k) clearance to market its 6F SuperStitch vascular suturing device and will launch the 6F device worldwide immediately.
World Heart. (Product Pipeline).(receives approval for additional subjects for Intrepid destination-therapy study)
November 1, 2001... * World Heart (Oakland, California) reported receiving FDA approval for an additional 15 subjects for the feasibility phase of its Intrepid destination-therapy study. The multicenter trial compares survival rates and quality of life between...