Cardiovascular Device Update articles from November 2002

Cardiovascular Device Update archives from November 2002

Drug-coated stents dominate, but other technologies edge onto stage.(trends in medical equipment enhancements)
November 1, 2002... WASHINGTON -- Much like the real estate mantra about location, drug-eluting stents grabbed the lion's share of attention during the late-September Transcatheter Cardiovascular Therapeutics 2002 conference at the Washington Convention Center....

CardioDynamics and other firms report findings at HFSA.(Heart Failure Society of America)(CardioDynamics International Corp.)
November 1, 2002... A Cardiovascular Device Update Staff Report CardioDynamics (San Diego, California), developer of Impedance Cardiography (ICG) technology and manufacturer of BioZ noninvasive digital cardiac function monitoring systems, said the results of...

Heart Choice program spurs changes in UK. (Report from Europe).(United Kingdom)(cardiac patients choose when and where they will be operated on)
November 1, 2002... A Cardiovascular Device Update Staff Report In a move spurred by the success of the Heart Choice pilot program, UK Health Secretary Alan Milburn has unveiled the next step in an effort to give more National Health Service (NHS) patients...

Sell-off of Centerpulse cardio units continues. (Report from Europe).(Centerpulse Orthopedics Inc. sells Vascutek to Terumo Corp.)(Brief Article)
November 1, 2002... Centerpulse (Zurich, Switzerland) said last month that it is selling its Vascutek (Glasgow, Scotland) vascular-grafts business to Terumo (Tokyo) in a deal valued at $170 million. Vascutek, acquired in 1990 by Centerpulse's predecessor company,...

`Powerhouse for improvement'. (Report from Europe).(government agencies merge)(Brief Article)
November 1, 2002... The plan to merge the UK's Medical Devices Agency (MDA) and Medicines Control Agency into a single entity next year will be a "powerhouse for improvement" in the regulation of healthcare technologies and therapies, in the view of Health...

Evotec, MediGene, in cardiology discovery. (Report from Europe).(Evotec BioSystems AG)(MediGene AG)(Brief Article)
November 1, 2002... MediGene (Martinsreid, Germany) has secured the cooperation of Evotec (Hamburg, Germany) in launching a new company out of MediGene's recently spun off cardiological drug discovery program. The new company will be known as Genovation. The...

CE mark for Thermosense system. (Report from Europe).(coronary temperature assessment system)(Brief Article)
November 1, 2002... Thermocore Medical (Guildford, UK) has completed a patient safety and feasibility trial for its Thermosense coronary temperature assessment system, with the thermograpy catheter receiving CE mark approval. Stefan Verheye, MD, of Middleheim...

Smallest ICD released in Europe. (Report from Europe).(implantable cardioverter defibrillator)(Brief Article)
November 1, 2002... Guidant (Indianapolis, Indiana) released in Europe its next-generation implantable defibrillator family, the Vitality implantable cardioverter defibrillator (ICD) system, which received the CE mark in July. The company touted the new devices'...

Bayer and Shield in homocystine test deal. (Report from Europe).(Bayer Diagnostics Div. and Axis-Shield Diagnostics Ltd. form product development agreement)(Brief Article)
November 1, 2002... Bayer Diagnostics (Tarrytown, New York) and Axis-Shield (Dundee, Scotland) have agreed to develop Shield's homocystine assays for use on the ADVIA Centaur and ACS:180 analyzer systems. Homocystinemia has been identified as a risk factor in...

AMI Semiconductor (AMIS; Pocatello, Idaho) said it has acquired the Micro Power Products Division (Carlsbad, California) of Microsemi (Irvine, California). (Acquisitions).(AMI Semiconductor Inc.)(Microsemi Corp.)(Brief Article)
November 1, 2002... AMI Semiconductor (AMIS; Pocatello, Idaho) said it has acquired the Micro Power Products Division (Carlsbad, California) of Microsemi (Irvine, California). The purchase of this medical mixed-signal group is the second acquisition to be...

Edwards Lifesciences (Irvine, California) has acquired the cardiovascular business in Japan it had been operating as a joint venture with Baxter International (Deerfield, Illinois). (Acquisitions).(Edwards Lifesciences Corp.)(Brief Article)
November 1, 2002... Edwards Lifesciences (Irvine, California) has acquired the cardiovascular business in Japan it had been operating as a joint venture with Baxter International (Deerfield, Illinois). The business, which had sales of about $170 million in 2001,...

Micro Therapeutics (MTI; Irvine, California) has completed its acquisition of Dendron GmbH (Bochum, Germany), a privately held maker of neurovascular-focused products such as embolic coils for the treatment of brain aneurysms. (Acquisitions).(Micro Therapeutics Inc.)(Brief Article)
November 1, 2002... Micro Therapeutics (MTI; Irvine, California) has completed its acquisition of Dendron GmbH (Bochum, Germany), a privately held maker of neurovascular-focused products such as embolic coils for the treatment of brain aneurysms. MTI will make...

Refac (Edgewater, New Jersey) said it has sold its product development business to Product Genesis LLC, an affiliate of Product Genesis (Cambridge, Massachusetts). (Acquisitions).(Brief Article)
November 1, 2002... Refac (Edgewater, New Jersey) said it has sold its product development business to Product Genesis LLC, an affiliate of Product Genesis (Cambridge, Massachusetts), a product development and design firm for the technology and medical devices...

New Oklahoma heart hospital is all-digital. (Business Developments).(medical technology and patient care)
November 1, 2002... Those who have a family member or friend being treated at the new Oklahoma Heart Hospital (Oklahoma City, Oklahoma) don't have to remain penned in at the hospital's waiting room for fear of missing a patient update. The coaster pagers--like...

AbioCor trial draws liability suit. (Business Developments).(artificial heart defects)(ABIOMED Inc.)
November 1, 2002... The widow of James Quinn, one of seven patients in the trial of the AbioCor replacement heart made by Abiomed (Danvers, Massachusetts), last month filed suit against the company and Hahnemann University Hospital (Philadelphia, Pennsylvania),...

Endovasc creates drug subsidiaries. (Business Developments).(Endovasc Ltd.)(Brief Article)
November 1, 2002... Endovasc (Montgomery, Texas) last month launched two subsidiaries: Liprostin Development, for its anti-inflammatory cardiovascular drug Liprostin, and Angiogenix Development for its nicotinic acetylcholine receptor agonist drug, Angiogenix....

Cardiac Science (Irvine, California), a manufacturer of automated public access defibrillators, has entered into an alliance with privately held Complient (Solon, Ohio). (Agreements).(Cardiac Science Inc.)(Complient Corp.)(Brief Article)
November 1, 2002... Cardiac Science (Irvine, California), a manufacturer of automated public access defibrillators, has entered into an alliance with privately held Complient (Solon, Ohio), an outsource provider of workplace AED programs, to roll-out a...

Diacrin (Charlestown, Massachusetts) signed a development and license agreement for Japan with Terumo (Tokyo). (Agreements).(Diacrin Inc.)(Terumo Corp.)(Brief Article)
November 1, 2002... Diacrin (Charlestown, Massachusetts) signed a development and license agreement for Japan with Terumo (Tokyo), an international pharmaceutical and medical device company. The license involves human muscle cell transplantation technology for...

Mobile PET Systems (San Diego, California), a provider of positron emission tomography (PET) imaging services to health care entities, and Bracco Diagnostics (Princeton, New Jersey) the U.S. operating company of the Bracco Group (Milan, Italy). (Agreements).(Brief Article)
November 1, 2002... Mobile PET Systems (San Diego, California), a provider of positron emission tomography (PET) imaging services to health care entities, and Bracco Diagnostics (Princeton, New Jersey) the U.S. operating company of the Bracco Group (Milan, Italy),...

Cook (Bloomington, Indiana) has signed a two-year agreement with the group purchasing arm of Premier (San Diego, California). (Agreements).(Brief Article)
November 1, 2002... Cook (Bloomington, Indiana) has signed a two-year agreement with the group purchasing arm of Premier (San Diego, California), one of the nation's largest not-for-profit hospital alliances for an offering of diagnostic and interventional...

New guidelines seen driving heart pacing. (Market Updates).(new pacemaker standards)
November 1, 2002... A newly revised set of guidelines, released last month by three prestigious medical groups in the heart therapy sector, promises a healthier outlook both for heart patients and those companies that make pacemakers and the newest generations of...

Defibrillation, if delayed, may be harmful. (Market Updates).(treating cardiac arrest patients)
November 1, 2002... About 10 minutes after the onset of cardiac arrest, little or no energy remains in the heart and it loses its ability to pump blood. And it is well-known that defibrillation of a heart attack patient has to come within 10 minutes--and the...

Task force sees estrogen/progestin heart risk. (Market Updates).(adverse side effects of hormone replacement therapy)
November 1, 2002... The U.S. Preventive Services Task Force last month recommended against the use of combined estrogen and progestin therapy for preventing cardiovascular disease and other chronic conditions in postmenopausal women. The task force, sponsored by...

Gene therapy for heart failure in hamsters. (Market Updates).(Brief Article)
November 1, 2002... An article in the August issue of Nature Medicine indicates a positive potential for gene therapy of the heart in hamsters. Currently, the only curative procedure for end-stage heart failure--a leading cause of death in Western countries--is an...

Studies pinpoint statin non-compliance. (Market Updates).(patient behavior)(Brief Article)
November 1, 2002... The failure of many people to take prescribed drugs is a well-known attribute of patient behavior, but two new studies show the problem may be epidemic among seniors who have been prescribed cholesterol-lowering statins. A recent study by...

Advanced Technology Ventures. (Personal File).(Brief Article)
November 1, 2002... * Stuart Randle has been named entrepreneur-inresidence in the healthcare practice of Advanced Technology Ventures (ATV; Palo Alto, California/Waltham, Massachusetts) and is charged with investigating medical device opportunities within...

Angiotech Pharmaceuticals. (Personal File).(Angiotech Pharmaceuticals Inc. selects independent chairman)(Brief Article)
November 1, 2002... * David Howard, MD, president and chief executive officer of SCOLR and a director of Angiotech Pharmaceuticals (Vancouver, British Columbia) since March 2000, will take the position of independent chairman of Angiotech from William Hunter, MD....

ATS Medical. (Personal File).(ATS Medical Inc. selects chief executive officer)(Brief Article)
November 1, 2002... * Michael Dale has been appointed president and chief executive officer of ATS Medical (Minneapolis, Minnesota). Dale most recently was vice president of worldwide sales and marketing at Endocardial Solutions. ATS Medical makes a pyrolitic...

CHF Solutions. (Personal File).(Brief Article)
November 1, 2002... * Steven Brandt has been named vice president of CHF Solutions (Brooklyn Park, Minnesota). Most recently, he was vice president of global marketing for the Cardiovascular Surgery Business of St. Jude Medical. CHF Solutions manufactures...

Edwards Lifesciences. (Personal File).(Edwards Lifesciences Corp. selects vice president)(Brief Article)
November 1, 2002... * Thomas Abate (Irvine, California) has been promoted from controller to vice president and controller of Edwards Lifesciences (Irvine, California). He previously served as corporate controller for Baxter's CardioVascular Group before the...

Endocardial Solutions. (Personal File).(Endocardial Solutions Inc. hires chief financial officer)(Brief Article)
November 1, 2002... * Bob Paulson, chief financial officer of Endocardial Solutions (Minneapolis/St. Paul, Minnesota), has been named to the additional post of interim head of global marketing. Paulson previously served as general manager, with global sales and...

Myocor. (Personal File).(Myocor Inc. selects chief executive officer)(Brief Article)
November 1, 2002... * Brian O'Connell has been named president and chief executive officer of Myocor (Minneapolis, Minnesota), succeeding Edward Andrle, who has served as interim president and CEO for the past nine months. Most recently, O'Connell was vice...

Qmed. (Personal File).(Qmed Inc. selects chief financial officer)(Brief Article)
November 1, 2002... * William Schmitt Jr. has been appointed senior vice president and chief financial officer of Qmed (Laurence Harbor, New Jersey). He previously was senior vice president and CFO of SOS Security, a privately held security, protection and...

Vasomedical. (Personal File).(Vasomedical Inc. selects new chief executive officer)(Brief Article)
November 1, 2002... * Photos Fred Paulson has been named chief executive officer of Vasomedical (Westbury, New York), replacing E. Michael Deignan, who has resigned to the position to pursue other interests, the company said. Deignan will remain as a company...

Viacor. (Personal File).(Jonathan Rourke named chief operating officer)(Brief Article)
November 1, 2002... * Jonathan Rourke has been named chief operating officer of Viacor (Danvers, Massachusetts). Rourke most recently was vice president of research and development at TransMedics. Viacor is a medical device company focused on congestive heart...

Corgentech E2F Decoy in 2nd Phase III trial. (Product Pipeline).(Corgentech Inc.)(oligonucleotide or short strand of DNA)
November 1, 2002... Corgentech (Palo Alto, California) said it started enrolling patients in a second Phase III trial for a product for use in coronary arterial and peripheral bypass grafting surgery. It should take Corgentech until the end of 2003 to enroll about...

Advanced Stent Technologies (AST; Pleasanton, California) received CE mark approval for its SLK-View stent and delivery system to treat cardiovascular disease at or near bifurcation points in the coronary vascular system. (Product Pipeline).(Advanced Stent Technologies Inc.)(Brief Article)
November 1, 2002... * Advanced Stent Technologies (AST; Pleasanton, California) received CE mark approval for its SLK-View stent and delivery system to treat cardiovascular disease at or near bifurcation points in the coronary vascular system. The approval also is...

Biotronik. (Product Pipeline).(Brief Article)
November 1, 2002... * Biotronik (Lake Oswego, Oregon) reported the first U.S. implantation of its Tachos DR-Atrial Tx, a dual-chamber implantable cardioverter defibrillator (ICD) with both atrial- and ventricular-tiered therapies. The Tachos DR-Atrial Tx ICD is...

Endocardial Solutions (St. Paul, Minnesota) said the first successful Digital Image Fusion (DIF) procedure using its EnSite 3000 System was performed at Sinai Medical Center (Milwaukee, Wisconsin) by Jasbir Sra, MD, clinical professor of medicine at the University of Wisconsin. (Product Pipeline).(Endocardial Solutions Inc.)(Brief Article)
November 1, 2002... * Endocardial Solutions (St. Paul, Minnesota) said the first successful Digital Image Fusion (DIF) procedure using its EnSite 3000 System was performed at Sinai Medical Center (Milwaukee, Wisconsin) by Jasbir Sra, MD, clinical professor of...

Endologix (Irvine, California) reported "favorable preliminary clinical results" from a Phase II pivotal trial of its PowerLink System, an endoluminal stent graft (ELG) for the treatment of abdominal aortic aneurysms (AAA). (Product Pipeline).(Endologix Inc.)(Brief Article)
November 1, 2002... * Endologix (Irvine, California) reported "favorable preliminary clinical results" from a Phase II pivotal trial of its PowerLink System, an endoluminal stent graft (ELG) for the treatment of abdominal aortic aneurysms (AAA). The results were...

Guidant (Indianapolis, Indiana) reported results of a study using optical coherence tomography (OCT), a new coronary imaging technology that provides resolution 10 times greater than intravascular ultrasound, to examine highly detailed images of complex coronary lesions in patients with coronary artery disease. (Product Pipeline).(Guidant Corp.)
November 1, 2002... * Guidant (Indianapolis, Indiana) reported results of a study using optical coherence tomography (OCT), a new coronary imaging technology that provides resolution 10 times greater than intravascular ultrasound, to examine highly detailed images...

Harbinger Medical (Eden Prairie, Minnesota) said that the FDA cleared its the Micro-Induction 1000 System, a high fidelity, active variance, electrocardiograph intended for use in stratifying the risk of cardiac disease patients. (Product Pipeline).(Brief Article)
November 1, 2002... * Harbinger Medical (Eden Prairie, Minnesota) said that the FDA cleared its the Micro-Induction 1000 System, a high fidelity, active variance, electrocardiograph intended for use in stratifying the risk of cardiac disease patients. In clinical...

Instromedix (San Diego, California), a Card Guard (Schaffhausen, Switzerland) company, is launching EasyTrace Plus software, a solution designed to allow healthcare providers to receive, measure, print and store cardiac and pulmonary data transmitted from Card Guard transtelephonic monitors. (Product Pipeline).(Instromedix Inc.)(Brief Article)
November 1, 2002... * Instromedix (San Diego, California), a Card Guard (Schaffhausen, Switzerland) company, is launching EasyTrace Plus software, a solution designed to allow healthcare providers to receive, measure, print and store cardiac and pulmonary data...

Lifecor. (Product Pipeline).(Lifecor Inc. introduces external wearable defibrillator)(Brief Article)
November 1, 2002... * Lifecor (Pittsburgh, Pennsylvania) reported receiving PMA clearance from the FDA for its third-generation LifeVest wearable defibrillator. FDA approval of the second-generation LifeVest was granted in December 2001 after conclusion of a...

MedImmune (Gaithersburg, Maryland) released Phase III data showing that Synagis reduces respiratory syncytial virus related hospitalizations in young children with congenital heart disease. (Product Pipeline).(MedImmune Inc.)(Brief Article)
November 1, 2002... * MedImmune (Gaithersburg, Maryland) released Phase III data showing that Synagis reduces respiratory syncytial virus related hospitalizations in young children with congenital heart disease. MedImmune, along with its partner Abbott...

Medinol. (Product Pipeline).(Medinol Ltd. )(Brief Article)
November 1, 2002... * Medinol (Tel Aviv, Israel), backed by what it termed "strong safety and efficacy results" of a U.S. clinical trial, submitted to the FDA a PMA application for its next-generation NIRflex Premounted Stent system. The multicenter, prospective,...

Medtronic. (Product Pipeline).(Medtronic Inc.)
November 1, 2002... * Medtronic (Minneapolis, Minnesota) received FDA approval of a new "multi-exchange" delivery system using its patented Zipper technology, a new system for interventional procedures. The approval covers the Stormer Balloon Dilitation Catheter...

Merit Medical Systems. (Product Pipeline).(Merit Medical Systems Inc. markets disposable safety needle)(Brief Article)
November 1, 2002... * Merit Medical Systems (South Jordan, Utah), a maker of disposable products used in cardiology and radiology procedures, has received FDA clearance to market its new safety needle, the Majestik Shielded Needle. The company said the potential...

Novare Surgical Systems (Cupertino, California) released at the European Association of Cardiothoracic Surgeons meeting in Monte Carlo, Monaco, its Cygnet line of dual-action aortic cross-clamps. (Product Pipeline).(Novare Surgical Systems Inc. introduces dual-action aortic cross-clamps)(Brief Article)
November 1, 2002... * Novare Surgical Systems (Cupertino, California) released at the European Association of Cardiothoracic Surgeons meeting in Monte Carlo, Monaco, its Cygnet line of dual-action aortic cross-clamps. The clamp's neck is designed to be either...

OmniSonics Medical Technologies (Wilmington, Massachusetts) said it received an investigational device exemption from the FDA to commence a U.S. clinical trial of its Resolution System for the treatment of thrombosed synthetic hemodialysis grafts. (Product Pipeline).(clinical trials of OmniSonics Medical Technologies Inc.'s thromboembolism treatment)(Brief Article)
November 1, 2002... * OmniSonics Medical Technologies (Wilmington, Massachusetts) said it received an investigational device exemption from the FDA to commence a U.S. clinical trial of its Resolution System for the treatment of thrombosed synthetic hemodialysis...

Orqis Medical. (Product Pipeline).(cardiovascular implant approved in Europe)(Brief Article)
November 1, 2002... * Orqis Medical (Lake Forest, California) said its Cancion family of minimally invasive cardiac recovery systems (CRS) received the CE mark following successful European clinical trials. The Orqis CRS system uses blood-pumping technology...

Quinton Cardiology Systems. (Product Pipeline).(Brief Article)
November 1, 2002... * Quinton Cardiology Systems (Bothell, Washington) said it has begun shipping telemetry systems operating at 608 MHz, dedicated by the Federal Communications Commission as a wireless medical telemetry services (WMTS) frequency. Clinical...

Scion Cardio-Vascular. (Product Pipeline).(Scion Cardio-Vascular Inc.)(Brief Article)
November 1, 2002... * Scion Cardio-Vascular (Miami, Florida) received CE marking for its Sci-Pro filter protection device. The Sci-Pro is a guidewire-based filter and retrieval system designed to provide protection during interventional surgical procedures such as...

Scios (Sunnyvale, California) presented at the American College of Emergency Physicians meeting in Seattle, Washington, four abstracts related to Natrecor (nesiritide). (Product Pipeline).(Scios Inc.)(Brief Article)
November 1, 2002... * Scios (Sunnyvale, California) presented at the American College of Emergency Physicians meeting in Seattle, Washington, four abstracts related to Natrecor (nesiritide). The presentations showed the benefits of Natrecor as an early treatment...

Velocimed. (Product Pipeline).(embolic protection device)(Brief Article)
November 1, 2002... * Velocimed (Minneapolis, Minnesota) said 15 of 30 patients required for a CE mark trial were enrolled in a study of the Proxis Embolic Protection System, the first proximal embolic protection device designed for coronary applications. The...