Cardiovascular Device Update articles from July 2003

Cardiovascular Device Update archives from July 2003

Innovation and technological solutions to clinical challenges. (CDU at the European Paris Course on Revascularization).
July 1, 2003... PARIS -- Conference leaders initiated a new feature at the 14th European Paris Course on Revascularization (EuroPCR), held here in late May. Ten emerging companies were selected from among many contenders based on the innovative nature of their...

State-of-art treatments for coronary artery disease an AATS focus. (CDU at the American Association for Thoracic Surgery).(American Association for Thoracic Surgery )
July 1, 2003... BOSTON, Massachusetts -- The 83rd annual meeting of the American Association for Thoracic Surgery (AATS; Beverly, Massachusetts) provided one of the first forums for cardiac surgeons to discuss the future impact of the new drug-eluting coronary...

Cardiovascular sourcebook honored, on track for revision.(Advances in Cardiovascular Technology: Emerging Markets for the 21st Century)(Brief Article)
July 1, 2003... Advances in Cardiovascular Technology: Emerging Markets for the 21st Century, a sourcebook produced by the BBI group of Thomson BioWorld, publishers of Cardiovascular Device Update, received second-place honors in the "Best Looseleaf...

COMET trial lauds benefits of carvedilol. (Report from Europe).(Carvedilol or Metoprolol European Trial)(adrenergic beta-antagonist for chronic heart failure)
July 1, 2003... According to the Carvedilol or Metoprolol European Trial (COMET), chronic heart failure (CHF) patients treated with the beta blocking agent carvedilol had a significant survival benefit--17% better than those taking the selective beta blocker...

Direct UK sales force for AED maker. (Report from Europe).(automated external defibrillator)(United Kingdom)(Brief Article)
July 1, 2003... Cardiac Science (Irvine, California) said in June that it has established a direct sales operation in the United Kingdom through the acquisition of LifeTec Medical Ltd. (Timperley, UK), which had been the principal distributor of the company's...

CARDS study halt validates Lipitor. (Report from Europe).(Collaborative AtoRvastatin Diabetes Study )
July 1, 2003... The Collaborative AtoRvastatin Diabetes Study (CARDS) Steering Committee announced last month that a major UK trial studying the reduction of cardiovascular disease (CVD) risk in Type 2 diabetes patients using the cholesterol-lowering medicine...

Abbott Laboratories (Abbott Park, Illinois) entered into an asset purchase agreement for the coronary and peripheral interventional business line of the Jomed Group, a provider of minimally invasive vascular interventional devices, for EUR 60 million. (Acquisitions).(Brief Article)
July 1, 2003... * Abbott Laboratories (Abbott Park, Illinois) entered into an asset purchase agreement for the coronary and peripheral interventional business line of the Jomed Group, a provider of minimally invasive vascular interventional devices, for EUR 60...

Alliance Pharmaceutical (San Diego, California) completed two previously announced deals, spinning off its medical imaging assets to Photogen Technologies (New Hope, Pennsylvania) and acquiring the other half of a joint venture it had developed with Baxter Healthcare (Deerfield, Illinois) for the marketing rights to Oxygent.. (Acquisitions).(Alliance Pharmaceutical Corp.)
July 1, 2003... * Alliance Pharmaceutical (San Diego, California) completed two previously announced deals, spinning off its medical imaging assets to Photogen Technologies (New Hope, Pennsylvania) and acquiring the other half of a joint venture it had...

BTG (London), a global technology commercialization company, said it has acquired an exclusive license to an imaging probe designed to identify plaque lesions associated with atherosclerosis. (Acquisitions).(Brief Article)
July 1, 2003... * BTG (London), a global technology commercialization company, said it has acquired an exclusive license to an imaging probe designed to identify plaque lesions associated with atherosclerosis. The contract was signed during last month's BIO...

Appeals court backs Boston Sci vs. Cook. (Business Developments).(Boston Scientific Corp. and Cook Group Inc. dispute over licensing agreements)
July 1, 2003... Boston Scientific (Natick, Massachusetts) reported June 20 that the U.S. Court of Appeals for the Seventh Circuit had "substantially affirmed" a U.S. District Court decision in favor of the company in its dispute with Cook (Bloomington,...

Biosite (San Diego, California) and Beckman Coulter (Fullerton, California) signed an agreement for Beckman Coulter to manufacture and Biosite to commercialize a b-type natriuretic peptide (BNP) test for use on Beckman Coulter's immunoassay systems. (Agreements).(Biosite Inc.)(Beckman Coulter Inc.)(Brief Article)
July 1, 2003... * Biosite (San Diego, California) and Beckman Coulter (Fullerton, California) signed an agreement for Beckman Coulter to manufacture and Biosite to commercialize a b-type natriuretic peptide (BNP) test for use on Beckman Coulter's immunoassay...

Epix Medical (Cambridge, Massachusetts) has formed an alliance with Schering AG (Berlin) for the discovery, development and commercialization of novel molecularly targeted contrast agents for magnetic resonance imaging. (Agreements).(EPIX Medical Inc.)(Brief Article)
July 1, 2003... * Epix Medical (Cambridge, Massachusetts) has formed an alliance with Schering AG (Berlin) for the discovery, development and commercialization of novel molecularly targeted contrast agents for magnetic resonance imaging. The first area of...

MedicalCV (Minneapolis, Minnesota), a heart valve manufacturer, signed a three-year agreement with Premier Purchasing Partners, the group purchasing division of Premier (San Diego, California) for MedicalCV's Omnicarbon mechanical heart valves, effective immediately. (Agreements).(MedicalCV Inc.)(Brief Article)
July 1, 2003... * MedicalCV (Minneapolis, Minnesota), a heart valve manufacturer, signed a three-year agreement with Premier Purchasing Partners, the group purchasing division of Premier (San Diego, California), for MedicalCV's Omnicarbon mechanical heart...

Vision-Sciences (Natick, Massachusetts) signed a development, supply and distribution agreement with privately held Estech (Danville, California) for products designed to provide access and visualization for minimally invasive cardiac surgery for the treatment and ablation of atrial fibrillation (AF). (Agreements).(Vision-Sciences Inc.)(Brief Article)
July 1, 2003... * Vision-Sciences (Natick, Massachusetts) signed a development, supply and distribution agreement with privately held Estech (Danville, California) for products designed to provide access and visualization for minimally invasive cardiac surgery...

ICD reimbursement seen as falling short. (Market Updates).(implantable cardioverter defibrillators)
July 1, 2003... A decision made last month by the Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland) means another 90,000 patients a year will qualify for reimbursement coverage to receive implantable cardioverter defibrillators (ICDs), but...

Needed: pediatric bedside blood monitoring. (Market Updates).
July 1, 2003... In hospitals nationwide, three out of four infants who die after undergoing high-risk congenital heart surgery could survive if doctors monitored blood at the bedside and rapidly detected and corrected life-threatening oxygen deficiencies,...

Type 1 diabetes: tight control pays off. (Market Updates).
July 1, 2003... New research unveiled at last month's annual meeting of the American Diabetes Association (ADA; Alexandria, Virginia) in New Orleans, Louisiana, indicates that tight control of Type 1 diabetes pays off in reduced atherosclerosis and other...

Alere Medical. (Personnel File).(Alere Medical Inc.)(vice president and chief medical officer selected)(Brief Article)
July 1, 2003... * Timothy Moore, MD, has been named chief medical officer and executive vice president for Alere Medical (Reno, Nevada). Moore most recently was chief medical officer and senior vice president of Health Net. Alere Medical is a privately held...

Novoste. (Personnel File).(Novoste Corp. )(employee promotions)(Brief Article)
July 1, 2003... * Andrew Green has been promoted to vice president, regulatory and clinical affairs, at Novoste (Norcross, Georgia). Since joining the company in 1996, he has held several positions in the regulatory affairs group. Novoste develops advanced...

FilterWire device gets nod from FDA. (Product Pipeline).(Food and Drug Administration)(Embolic Protection System )
July 1, 2003... A second company earned U.S. regulatory approval in the embolic protection field last month, with Boston Scientific's (Natick, Massachusetts) FilterWire EX Embolic Protection System joining Medtronic's (Minneapolis, Minnesota) PercuSurge...

Arrow International. (Product Pipeline).(outcome of cardiovascular implant)(Brief Article)
July 1, 2003... * Arrow International (Reading, Pennsylvania) reported the outcome of the first human implant of the CorAide continuous-flow ventricular assist system. The device was implanted as a bridge to transplant in a 65-year-old German male patient on...

Biotronik (Lake Oswego, Oregon) reported the first five nationwide implants of the Cardiac Airbag ICD System. (Product Pipeline).(Biotronik Inc.)(implantable cardioverter-defibrillators)(Brief Article)
July 1, 2003... * Biotronik (Lake Oswego, Oregon) reported the first five nationwide implants of the Cardiac Airbag ICD System. This new device is designed to address the demand for affordable patient care by combining targeted therapy with an e-commerce...

CardiacAssist. (Product Pipeline).(Cardiacassist Inc.)(cardiogenic shock systems approved for marketing)(Brief Article)
July 1, 2003... * CardiacAssist (Pittsburgh, Pennsylvania) received 510(k) clearance from the FDA for its Transseptal Cannula, part of the company's TandemHeart Percutaneous Transseptal Ventricular Assist (PTVA) System. Cardiologists and cardiac surgeons...

Cardiac Science (Irvine, California) said the June 1 edition of the American Journal of Cardiology included a clinical study that demonstrates the high level of sensitivity and specificity of the company's Powerheart CRM fully-automatic bedside monitor defibrillator in detecting and providing therapy for life-threatening supraventricular tachycardia (SVT) arrhythmias. (Product Pipeline).(Brief Article)
July 1, 2003... * Cardiac Science (Irvine, California) said the June 1 edition of the American Journal of Cardiology included a clinical study that demonstrates the high level of sensitivity and specificity of the company's Powerheart CRM fully-automatic...

The Circulatory System Devices panel of the FDA voted unanimously last month that Cardima's (Fremont, California) Revelation Tx Microcatheter Ablation System for the treatment of atrial fibrillation (AF) was "not approvable." (Product Pipeline).(Food and Drug Administration)(Cardima Inc.)(Brief Article)
July 1, 2003... * The Circulatory System Devices panel of the FDA voted unanimously last month that Cardima's (Fremont, California) Revelation Tx Microcatheter Ablation System for the treatment of atrial fibrillation (AF) was "not approvable." The panel...

CardioDynamics (San Diego, California) reported the publication of an international clinical study demonstrating the significance of the company's ICG technology for pacemaker optimization in Pace, a peer-reviewed publication in the field of electrophysiology. (Product Pipeline).(Brief Article)
July 1, 2003... * CardioDynamics (San Diego, California) reported the publication of an international clinical study demonstrating the significance of the company's ICG technology for pacemaker optimization in Pace, a peer-reviewed publication in the field of...

In what the company believes is a potentially huge breakthrough, CardioGenesis (Foothill Ranch, California), a developer of angina-relieving transmyocardial revascularization (TMR) and percutaneous myocardial revascularization (PMR) products,.
July 1, 2003... In what the company believes is a potentially huge breakthrough, CardioGenesis (Foothill Ranch, California), a developer of angina-relieving transmyocardial revascularization (TMR) and percutaneous myocardial revascularization (PMR) products,...

CardioTech International. (Product Pipeline).(safety of encapsulted coronary stents)(Brief Article)
July 1, 2003... * CardioTech International (Woburn, Massachusetts) reported the conclusion of an in vivo study using a microporous polyurethane-encapsulated coronary artery stent. This opens a potential market of $3 billion annually in the drug-eluting stent...

Fluke Biomedical. (Product Pipeline).(patient simulator)(Brief Article)
July 1, 2003... * Fluke Biomedical (Everett, Washington) introduced the new multi-parameter patient simulator, MPS450, a complete redesign of the Bio-Tek Lionheart 3 product. The MPS450 has many new features and functions, including a menu-driven interface...

Gish Biomedical (Rancho Santa Margarita, California), a wholly owned subsidiary of CardioTech International (Woburn, Massachusetts), has gained FDA clearance for its heparin coating to be used in conjunction with its line of heart-lung bypass products, and it thus opens a door for use of heparin coatings on many more CardioTech products, according to the company. (Product Pipeline).(Brief Article)
July 1, 2003... * Gish Biomedical (Rancho Santa Margarita, California), a wholly owned subsidiary of CardioTech International (Woburn, Massachusetts), has gained FDA clearance for its heparin coating to be used in conjunction with its line of heart-lung bypass...

Guidant (Indianapolis, Indiana) said it has enrolled the first patient in its second clinical trial designed to evaluate carotid artery stenting as a minimally invasive alternative for patients who are at high risk for stroke and who are ineligible for current surgical options or at high surgical risk. (Product Pipeline).(Guidant Corp.)(Brief Article)
July 1, 2003... * Guidant (Indianapolis, Indiana) said it has enrolled the first patient in its second clinical trial designed to evaluate carotid artery stenting as a minimally invasive alternative for patients who are at high risk for stroke and who are...

Imagyn Medical Technologies. (Product Pipeline).(marketing for endotracheal cardiac output monitor approved)(Brief Article)
July 1, 2003... * Imagyn Medical Technologies (Irvine, California), a developer of internal bioelectrical impedance technology, last month received 510(k) clearance to market its ECOM endotracheal cardiac output monitor in the U.S. The approval permits use of...

i-STAT. (Product Pipeline).(i-STAT Corp.)(hand-held heart attack diagnostic test)(Brief Article)
July 1, 2003... * i-STAT (East Windsor, New Jersey) said a study showed that its hand-held, point-of-care test for diagnosing heart attacks is comparable to tests evaluated by central laboratory instruments. The i-STAT system cardiac troponin I test scans the...

Medtronic. (Product Pipeline).(Medtronic Inc.)(heart beat monitoring equipment)
July 1, 2003... * Medtronic (Minneapolis, Minnesota) reported the first uses of the EnPulse pacing system in several patients to begin a clinical evaluation of this new device for slow-beating hearts. The device is designed to continuously measure changes in...

MIV Therapeutics. (Product Pipeline).(thrombogenicity of coated stents)(Brief Article)
July 1, 2003... * MIV Therapeutics (MIVT; Vancouver, British Columbia) said it has achieved a significant milestone by successfully passing an independent thrombogenicity animal trial of its proprietary hydroxyapatite (HAp) coating. Stainless steel and...

Nuvelo. (Product Pipeline).(Nuvelo Inc. tests safety of catheter)(Brief Article)
July 1, 2003... * Nuvelo (Sunnyvale, California) reported the start of dosing in a Phase II trial with its lead product candidate, alfimeprase, for the treatment of catheter occlusion. The multi-center, randomized, double-blind study will evaluate the safety...

Rheologics (Exton, Pennsylvania) said that its scanning blood viscometer, the Rheolog, has been selected for use in a clinical study on congestive heart failure (CHF) at Christiana Care Health Services (Wilmington, Delaware). (Product Pipeline).(Brief Article)
July 1, 2003... * Rheologics (Exton, Pennsylvania) said that its scanning blood viscometer, the Rheolog, has been selected for use in a clinical study on congestive heart failure (CHF) at Christiana Care Health Services (Wilmington, Delaware). The six-month...

St. Jude Medical. (Product Pipeline).(evaluation of implantable cardioverter defibrillators)(Brief Article)
July 1, 2003... * St. Jude Medical (St. Paul, Minnesota) reported enrollment of the first patients in its RHYTHM ICD V-V (left ventricle, right ventricle) optimization phase of the RHYTHM (Resynchronization Hemodynamic Treatment for Heart Failure Management)...

University of Pittsburgh. (Product Pipeline).(engineered tissue treats heart defects)(Brief Article)
July 1, 2003... * William Wagner, MD, associate professor of surgery and bioengineering and deputy director of the University of Pittsburgh's (Pittsburgh, Pennsylvania) McGowan Institute for Regenerative Medicine, has developed an engineered tissue to treat...

Vitatron. (Product Pipeline).(medical diagnostic software)(Brief Article)
July 1, 2003... * Vitatron (Minneapolis, Minnesota) reported FDA approval of its Vitatron Ventricular Rate Stabilization (VRS), a software upgrade for patients who have an implanted Vitatron Selection AFm pacemaker system. VRS can help stabilize the rate of...

Zargis Medical. (Product Pipeline).(medical diagnostic software)(Brief Article)
July 1, 2003... * Zargis Medical (Princeton, New Jersey) said it has submitted a 510(k) application to the FDA for clearance to market the Zargis Acoustic CardioScan system (ZACS). ZACS is based on a computer-aided analysis of heart sounds and is designed to...