Cardiovascular Device Update articles from October 2003

Cardiovascular Device Update archives from October 2003

Slow adoption of new device technologies seen in Europe.(CDU at the European Society of Cardiology Congress)
October 1, 2003... VIENNA, Austria -- The market for products used in the diagnosis and treatment of cardiovascular disease in Europe is the second-largest regional market worldwide after the U.S., and has historically been the first to adopt new device...

Lukewarm COOL-MI results don't deter Radiant on cooling.(CDU at the Transcatheter Cardiovascular Therapeutics Symposium)(Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients in Acute Myocardial Infarction )
October 1, 2003... WASHINGTON -- Although drug-eluting stents clearly captured the limelight at this year's Transcatheter Cardiovascular Therapeutics (TCT) symposium held here last month, the wide breadth of other topics in the world of interventional medicine...

Two firms take aim at cryotherapy approach to treatment of AF.(CryoCath Technologies; CryoCor; atrial fibrillation)
October 1, 2003... Two companies reported progress in mid-September toward their goal of FDA approval for a cryotherapeutic treatment for atrial fibrillation (AF), the most prevalent form of cardiac arrhythmia in the world. CryoCath Technologies (Montreal,...

Phillips marries its monitoring, AED expertise in the MRx.(Philips Electronics launches HeartStart MRx monitor/defibrillator)
October 1, 2003... Philips Electronics (Andover, Massachusetts) last month reported the launch of its HeartStart MRx, a monitor/defibrillator offering a broad range of features and capabilities designed to meet the needs of those providing basic defibrillation,...

Icelandic researchers link gene to stroke.(Report from Europe)
October 1, 2003... A CDU Staff Report Icelandic researchers report identifying a gene that is associated with susceptibility to stroke. Their findings appear in the October issue of Nature Genetics. Co-senior author is medical geneticist and neurologist Kari...

Scotland focuses on younger stroke victims.(Report from Europe)
October 1, 2003... A new study into the experiences of younger stroke survivors in Scotland, commissioned and published by the medical charity Chest, Heart & Stroke Scotland (Edinburgh, Scotland) and launched last month at a gathering in Glasgow by Minister of...

Device coating antibiotic eyed.(Report from Europe)(biodegradable polymer may aid in reducing infection associated with the use of medical implants)(Brief Article)
October 1, 2003... Researchers from the school of pharmacy at Queen's University Belfast (Belfast, Northern Ireland) reported at last month's British Pharmaceutical Conference on development of a new biodegradable polymer they say has potential application in...

Cerchiari joins Snia.(Report from Europe)(Dr. Drago Alberto Cerchiari appointed general manager)(Brief Article)
October 1, 2003... Dr. Drago Alberto Cerchiari has joined Snia (Milan, Italy) as general manager. He will work with Umberto Rosa, chairman and chief executive officer, in the planning process to restructure and demerge the company's chemicals, fibers and...

Beckman Coulter (Fullerton, California) has acquired the technologies of Peoples Genetics (PGI; Woburn, Massachusetts), used for the comprehensive genetic analysis of large pooled populations of individual patient DNAs.(Acquisitions)(Brief Article)
October 1, 2003... Beckman Coulter (Fullerton, California) has acquired the technologies of Peoples Genetics (PGI; Woburn, Massachusetts), used for the comprehensive genetic analysis of large pooled populations of individual patient DNAs. Details of the cash...

Thoratec (Pleasanton, California), a manufacturer of products to treat cardiovascular disease, said its International Technidyne (ITC; Edison, New Jersey) subsidiary has completed its previously reported asset purchase agreement Response Mobile Analysis (IRMA) point-of-care (POC) blood analysis system product line.(Acquisitions)(Brief Article)
October 1, 2003... Thoratec (Pleasanton, California), a manufacturer of products to treat cardiovascular disease, said its International Technidyne (ITC; Edison, New Jersey) subsidiary has completed its previously reported asset purchase agreement to acquire the...

Panel says 'no' to new use for CVX-300 laser.(Business Developments)(FDA Circulatory System Devices advisory panel votes against Spectranetics' CVX-300 excimer laser system )
October 1, 2003... The FDA Circulatory System Devices advisory panel early this month grappled with the question of whether a laser alone was as effective in treating patients with blocked arteries as balloon angioplasty and overwhelmingly voted 9-1 against...

Bristol-Myers Squibb (New York) and Corgentech (South San Francisco, California), a privately held biotechnology company, have entered into an agreement to jointly develop and commercialize Corgentech's E2F Decoy (edifoligide sodium).(Agreements)(Brief Article)
October 1, 2003... Bristol-Myers Squibb (New York) and Corgentech (South San Francisco, California), a privately held biotechnology company, have entered into an agreement to jointly develop and commercialize Corgentech's E2F Decoy (edifoligide sodium), a...

Predictive medicine company IMI International Medical Innovations (Toronto, Ontario) has signed a collaborative research agreement with AtheroGenics (Alpharetta, Georgia).(Agreements)(Brief Article)
October 1, 2003... Predictive medicine company IMI International Medical Innovations (Toronto, Ontario) has signed a collaborative research agreement with AtheroGenics (Alpharetta, Georgia). IMI's cardiovascular risk assessment test, Cholesterol 1,2,3, will be...

Moore Medical (New Britain, Connecticut), a multi-channel specialty marketer and distributor of medical, surgical and pharmaceutical products to healthcare professionals in non-hospital settings, has entered into a multi-year agreement with Health Professionals Ltd.(Agreements)(Brief Article)
October 1, 2003... Moore Medical (New Britain, Connecticut), a multi-channel specialty marketer and distributor of medical, surgical and pharmaceutical products to healthcare professionals in non-hospital settings, has entered into a multi-year agreement with...

Oxford Health Plans (Trumbull, Connnecticut) reported a new five-year agreement with American Healthways (Nashville, Tennessee), the nation's largest provider of disease management and care enhancement services.(Agreements)(Brief Article)
October 1, 2003... Oxford Health Plans (Trumbull, Connnecticut) reported a new five-year agreement with American Healthways (Nashville, Tennessee), the nation's largest provider of disease management and care enhancement services. In addition to providing...

Quinton Cardiology Systems (Bothell, Washington) and QRS Diagnostic (Plymouth, Minnesota), a maker of software-based medical devices contained on computer cards, jointly announced a strategic partnership under which Quinton will sell several QRS devices for cardiopulmonary diagnosis under the Burdick brand name.(Agreements)(Brief Article)
October 1, 2003... Quinton Cardiology Systems (Bothell, Washington) and QRS Diagnostic (Plymouth, Minnesota), a maker of software-based medical devices contained on computer cards, jointly announced a strategic partnership under which Quinton will sell several...

CMS to cover VADs in destination therapy.(Market Updates)(Centers for Medicare and Medicaid Services to allow coverage of ventricular assist devices)
October 1, 2003... After several long months, the Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland) in late September agreed to expand the coverage of ventricular assist devices (VADs) as permanent cardiac support for certain Medicare...

ABIOMED.(Personnel File)(Bradley Goskowicz appointed vice president; Anthony Bailey promoted to senior vice president)(Brief Article)
October 1, 2003... Bradley Goskowicz has been named vice president of Abiomed (Danvers, Massachusetts), and Anthony Bailey has been promoted from vice president for business development to senior vice president for operations. Most recently, Goskowicz was vice...

Advanced Stent Technologies.(Personnel File)(Jerry Caulder appointed chief executive officer and Jay Brumfield appointed chief operating officer)(Brief Article)
October 1, 2003... Advanced Stent Technologies (AST; Pleasanton, California) has named Jerry Caulder, PhD, chairman and chief executive officer, and Jay Brumfield president and chief operating officer. Caulder previously was executive chairman and CEO of Myelos...

Atherotech.(Personnel File)(Ted Fendley appointed vice president)(Brief Article)
October 1, 2003... Ted Fendley, PhD, has been appointed vice president of operations for Atherotech (Birmingham, Alabama). Most recently, he served for more than 15 years as associate vice president at Laboratory Corporation of America. Atherotech is a...

CardioNow.(Personnel File)(Barry Adelmann promoted to vice president of sales and marketing; Larry Heminger promoted to president of research and development)(Brief Article)
October 1, 2003... CardioNow (Encinitas, California) has promoted Barry Adelmann to vice president of sales and marketing and Larry Heminger to vice president of research and development. The company also said that Dr. Raul Perez of Oakwood Medical has joined the...

CryoCor.(Personnel File)(Ruchir Sehra appointed medical director)(Brief Article)
October 1, 2003... Ruchir Sehra, MD, has been named medical director for CryoCor (San Diego, California), with responsibility for managing the company's clinical affairs department. Sehra has held numerous academic and professional positions at Loma Linda...

MedCath.(Personnel File)(John Casey appointed president and chief executive officer; Charles Slaton named executive vice president and chief operating officer)(Brief Article)
October 1, 2003... John Casey has been named president and chief executive officer of MedCath (Charlotte, North Carolina). Additionally, Charles Slaton has been named executive vice president and chief operating officer. Casey replaces David Crane, who resigned...

Vasomedical.(Personnel File)(Thomas Fry appointed Chief Financial Officer; Wayne Stewart appointed vice president of domestic sales)(Brief Article)
October 1, 2003... Vasomedical (Westbury, New York) reported the appointments of Thomas Fry as chief financial officer and Wayne Stewart as vice president of domestic sales. Fry most recently served as chief financial officer at BEI Medical Systems. Stewart most...

Ventracor.(Personnel File)(Dr. Monica Hope appointed clinical trials manager; David Smullen named chief financial officer)(Brief Article)
October 1, 2003... Dr. Monica Hope has been named clinical trials manager for Ventracor (Sydney, Australia), and David Smullen has been named chief financial officer. Hope was previously regulatory affairs, quality assurance and clinical trials manager with...

Boston Sci gets pair of product approvals.(Product Pipeline)(Boston Scientific)(Brief Article)
October 1, 2003... Boston Scientific (Natick, Massachusetts) received premarket approval from the FDA last month for its EPT-1000 XP Cardiac Ablation System for the treatment of atrial flutter. Successful ablation procedures occur when a linear lesion is created...

Alteon.(Product Pipeline)(Brief Article)
October 1, 2003... Alteon (Ramsey, New Jersey) said it would continue its clinical development of ALT-711, its lead A.G.E. Crosslink Breaker compound, in both systolic hypertension and heart failure, despite a setback reported earlier this summer. The company in...

AngioScore.(Product Pipeline)(Brief Article)
October 1, 2003... AngioScore (Alameda, California) reported the successful initiation of the ACE (AngioSculpt Catheter Evaluation) clinical study of its AngioSculpt scoring catheter, with 15 patients having completed treatment. The AngioSculpt includes an...

bioMerieux.(Product Pipeline)(Brief Article)
October 1, 2003... bioMerieux (Durham, North Carolina) said it has received FDA clearance for its VIDAS D-Dimer extended-range D-dimer assay to exclude the presence of suspected deep vein thrombosis and aid in the diagnosis of pulmonary embolism in outpatients.

Cambridge Heart (Bedford, Massachusetts) said it has begun the MASTER (Microvolt T-Wave AlternanS TEsting for Risk Stratification of Post MI Patients) clinical trial.(Product Pipeline)(Brief Article)
October 1, 2003... Cambridge Heart (Bedford, Massachusetts) said it has begun the MASTER (Microvolt T-Wave AlternanS TEsting for Risk Stratification of Post MI Patients) clinical trial. The trial will target postmyocardial infarction (MI) patients whose hearts...

CHF Solutions.(Product Pipeline)(Brief Article)
October 1, 2003... CHF Solutions (Brooklyn Park, Minnesota) said that data presented as a poster at late September's Heart Failure Society of America meeting in Las Vegas, Nevada, showed that ultrafiltration using its System 100 Fluid Removal System is a safe and...

Corgentech.(Product Pipeline)(Brief Article)
October 1, 2003... Corgentech (South San Francisco, California) has completed patient enrollment in a pivotal Phase III clinical trial to evaluate its lead product, CGT003, a therapy for the prevention of graft failure following coronary artery bypass graft...

Guidant.(Product Pipeline)(Brief Article)
October 1, 2003... Guidant (Indianapolis, Indiana) reported completion of patient enrollment in its second clinical trial designed to evaluate carotid artery stenting as a minimally invasive alternative for patients who are ineligible for current surgical options...

IDev Technologies.(Product Pipeline)(Brief Article)
October 1, 2003... IDev Technologies (Houston, Texas) received 510(k) clearance from the FDA to market the AKonya Eliminator thrombectomy device in the U.S. The device is cleared for use in the declotting of synthetic dialysis grafts. The AKonya Eliminator is a...

ImaRx Therapeutics.(Product Pipeline)(Brief Article)
October 1, 2003... ImaRx Therapeutics (Tucson, Arizona) said that it initiated clinical trials to investigate the use of its SonoLysis Technology for the treatment of blood clots in kidney dialysis patients whose access grafts have become blocked. The SonoLysis...

i-STAT.(Product Pipeline)(Brief Article)
October 1, 2003... i-STAT (East Windsor, New Jersey) has received FDA clearance to market its 10-minute i-STAT System Cardiac Troponin I (cTnI) test. The company said the test is the first product in the market that offers central laboratory-grade performance at...

Kensey Nash.(Product Pipeline)(Brief Article)
October 1, 2003... Kensey Nash (Exton, Pennsylvania) has initiated the clinical study of a new version of its TriActiv Balloon Protected Flush Extraction System for carotid stenting procedures. The new device represents an extension of the company's core TriActiv...

Molecular Insight Pharmaceuticals.(Product Pipeline)(Brief Article)
October 1, 2003... Molecular Insight Pharmaceuticals (Indianapolis, Indiana) said it will proceed with Phase III trials of its molecular imaging pharmaceutical, (123I)-BMIPP, for the visualization of cardiac metabolism. This decision was based on the positive...

Novare Surgical Systems.(Product Pipeline)(Brief Article)
October 1, 2003... Novare Surgical Systems (Cupertino, California) reported the issuance of U.S. patent No. 6,544,274 covering its Cygnet line of dual-action surgical clamps for minimally invasive coronary artery bypass graft surgery, valve replacement surgery...

Pharmacyclics.(Product Pipeline)(Brief Article)
October 1, 2003... Pharmacyclics (Sunnyvale, California) reported the publication of data from its Phase I clinical trial of Antrin (motexafin lutetium) Phototherapy, an investigational treatment for atherosclerotic plaque, in a recent issue of Circulation. The...

QRS Diagnostic.(Product Pipeline)(Brief Article)
October 1, 2003... QRS Diagnostic (Minneapolis, Minnesota) introduced the re-designed OxiCard, a pulse oximeter that provides instant, noninvasive measurement of pulse rates and oxygen saturation in the blood. The re-designed device is built into a compact flash...

Quinton Cardiology Systems.(Product Pipeline)(Brief Article)
October 1, 2003... Quinton Cardiology Systems (Deerfield, Wisconsin) said it has started shipping the new CardioVive AED under the Burdick brand name. The CardioVive AED provides continuous monitoring capabilities during and after resuscitation. The compact unit...

Recom Managed Systems.(Product Pipeline)(Brief Article)
October 1, 2003... Recom Managed Systems (Los Angeles, California) said that a 510(k) premarket notification for the Recom Wireless EKG System has been submitted to the FDA. Recom's plans to market its initial device, a wireless electrocardiograph system (EKG),...

Ventracor.(Product Pipeline)(Brief Article)
October 1, 2003... Ventracor (Sydney, Australia) said it has been issued two new patents. U.S. patent No. 6,609,883, titled "Rotary Pump with Hydrodynamically Suspended Impeller," includes features not previously claimed in earlier patents for its VentrAssist...

VNUS Medical Technologies.(Product Pipeline)(Brief Article)
October 1, 2003... VNUS Medical Technologies (San Jose, Califoria) reported the introduction of a new radiofrequency delivery device, Closure PLUS, for the treatment of saphenous vein reflux. The Closure System has previously been shown in multiple randomized...

World Heart.(Product Pipeline)(Brief Article)
October 1, 2003... World Heart (Ottawa, Ontario) said Health Canada has approved its submission to incorporate enhancements to its Novacor LVAS (left ventricular assist system). The refinements are intended primarily to enhance recipients' quality of life by...