Cardiovascular Device Update articles from May 2004

Cardiovascular Device Update archives from May 2004

New devices for early detection, treatment of MI attract interest.(myocardial infarction)
May 1, 2004... NEW ORLEANS, Louisiana -- Early detection and rapid treatment is one of the most effective strategies available to physicians for improving outcomes of patients with myocardial infarction. A variety of technologies are under development that...

Stunning results seen from revascularization and other clinical data.
May 1, 2004... NEW ORLEANS, Louisiana -- Presenters revealed some stunning data in coronary and peripheral revascularization during a press conference on late-breaking trials at the American College of Cardiology's (ACC; Bethesda, Maryland) annual scientific...

GE Healthcare shines spotlight on its growing presence in cardiology.
May 1, 2004... NEW ORLEANS, Louisiana -- At the American College of Cardiology (Bethesda, Maryland) scientific sessions in early March at the Ernest N. Morial Convention Center, the sprawling exhibit floor was, as usual, a bustling center of activity. Perhaps...

Eyeing next-generation device, Arrow defers U.S. trial of LionHeart.(LionHeart Left Ventricular Assist System)
May 1, 2004... Arrow International (Reading, Pennsylvania) said last month that it plans to defer a U.S. clinical trial of its current iteration of the LionHeart Left Ventricular Assist System (LVAS) for a destination therapy indication, saying it prefers to...

UK cites progress in coronary disease effort.(Report from Europe)
May 1, 2004... Major progress has been made in the treatment of coronary heart disease in the UK, according to a report issued by Health Secretary John Reid. The report, Winning the War on Heart Disease, said that deaths from cardiovascular disease in the UK...

Guidant launches FUTURE III trial.
May 1, 2004... Guidant (Indianapolis, Indiana) last month reported the first enrollment of its FUTURE III trial in Germany, providing launch of the trial outside the U.S., primarily in Europe, but also in the Middle East, Asia, Australia, Canada and New...

CHF marker rights acquired.(congestive heart failure)(Brief Article)
May 1, 2004... Inverness Medical Innovations (Waltham, Massachusetts) gained rights to a biomarker technology from the Roche Diagnostics unit of F. Hoffmann-La Roche (Basel, Switzerland). Through its Inverness Medical Switzerland GmbH subsidiary,...

Clarification.(Correction Notice)
May 1, 2004... A story in the January issue of CDU included an incorrect reference to the InRatio point-of-care tester for prothrombin time as being an i-STAT (East Windsor, New Jersey) product. InRatio is manufactured by HemoSense (Milpitas, California).

Arrhythmia Research Technology (ART; Fitchburg, Massachusetts) said its wholly owned subsidiary, Micron Products, has completed the purchase of substantially all of the operating assets of privately held New England Molders (NEMI; Shrewsbury, Massachusetts).(Acquisitions)(Brief Article)
May 1, 2004... Arrhythmia Research Technology (ART; Fitchburg, Massachusetts) said its wholly owned subsidiary Micron Products, has completed the purchase of substantially all of the operating assets of privately held New England Molders (NEMI; Shrewsbury,...

Guidant (Indianapolis, Indiana) reported it has completed the $6 million purchase of the remaining stake in a company developing fully bioabsorbable drug-eluting stent platforms.(Acquisitions)(Brief Article)
May 1, 2004... Guidant (Indianapolis, Indiana) reported it has completed the $6 million purchase of the remaining stake in a company developing fully bioabsorbable drug-eluting stent platforms. The acquired company was originally founded by SyneCor (Research...

In conjunction with Optical Sensors' (Minneapolis, Minnesota) name change to Vasamed, the company said it has acquired a proprietary impedance cardiography (ICG) technology for non-invasive cardiac output (NICO) monitoring.(Acquisitions)(Brief Article)
May 1, 2004... In conjunction with Optical Sensors' (Minneapolis, Minnesota) name change to Vasamed, the company said it has acquired a proprietary impedance cardiography (ICG) technology for non-invasive cardiac output (NICO) monitoring. Paulita LaPlante,...

UTI (Collegeville, Pennsylvania) reported that it has agreed to acquire MedSource Technologies (Minneapolis, Minnesota), saying that the purchase will make it one of the largest contract manufacturing, design and engineering companies serving the medical technology market.(Acquisitions)(Brief Article)
May 1, 2004... UTI (Collegeville, Pennsylvania) reported that it has agreed to acquire MedSource Technologies (Minneapolis, Minnesota), saying that the purchase will make it one of the largest contract manufacturing, design and engineering companies serving...

Zoll Medical (Chelmsford, Massachusetts), a manufacturer of non-invasive cardiac resuscitation devices, has entered into an exclusive license agreement with Lifecor (Pittsburgh, Pennsylvania).(Acquisitions)(Brief Article)
May 1, 2004... Zoll Medical (Chelmsford, Massachusetts), a manufacturer of non-invasive cardiac resuscitation devices, has entered into an exclusive license agreement with Lifecor (Pittsburgh, Pennsylvania). Under this license agreement, Zoll has acquired all...

Novoste buys VBT assets of Guidant.(Business Developments)(vascular brachytherapy )
May 1, 2004... In a move designed to shore up its sagging vascular brachytherapy (VBT) sales, which have been ravaged by the drug-eluting stent (DES) phenomenon, Novoste (Norcross, Georgia) said in an earnings conference call last month that it had signed an...

Medtronic recalls two ICDs.(Business Developments)(implantable cardioverter defibrillator)(Brief Article)
May 1, 2004... Medtronic (Minneapolis, Minnesota) reported in April the voluntary recall of two older implantable cardioverter defibrillator (ICD) models after it became aware of four deaths and one serious injury that could be related to the failure of a key...

MIV raises funds for coating technology.(Business Developments)(MIV Therapeutics )(Brief Article)
May 1, 2004... MIV Therapeutics (MIVT; Vancouver, British Columbia) has raised additional funds necessary for completion of the next stage of its research and development program leading toward commercialization of its biocompatible coating technology...

Ventracor adds to production capability.(Business Developments)(Brief Article)
May 1, 2004... Ventracor (Sydney, Australia) reported it will enhance its production capability to manufacture its VentrAssist "artificial heart" to meet expected global demand for the product. Ventracor's chief executive officer, Dr. Colin Sutton, said the...

Alliance Medical (Phoenix, Arizona), a reprocessor of single-use medical devices (SUDs), said VHA (Irving, Texas), a cooperative of community-owned healthcare organizations, has renewed a three-year contract with Alliance.(Agreements)(Brief Article)
May 1, 2004... Alliance Medical (Phoenix, Arizona), a reprocessor of single-use medical devices (SUDs), said VHA (Irving, Texas), a cooperative of community-owned healthcare organizations, has renewed a three-year contract with Alliance. Alliance will be one...

American Healthways (Nashville, Tennessee), a provider of disease management, care enhancement and high-risk health management programs, unveiled a five-year agreement with Preferred Care Partners (Miami, Florida) to offer its diabetes, cardiac, chronic obstructive pulmonary disease, asthma and 11 impact condition programs to the health plan's 7,500 Medicare+Choice members beginning July 1.(Agreements)(Brief Article)
May 1, 2004... American Healthways (Nashville, Tennessee), a provider of disease management, care enhancement and high-risk health management programs, unveiled a five-year agreement with Preferred Care Partners (Miami, Florida) to offer its diabetes,...

Endologix (Irvine, California) has signed an agreement with Edwards Lifesciences (also Irvine) for Edwards to distribute the Endologix PowerLink System in selected European markets, including Belgium, France, Germany and the UK.(Agreements)(Brief Article)
May 1, 2004... Endologix (Irvine, California) has signed an agreement with Edwards Lifesciences (also Irvine) for Edwards to distribute the Endologix PowerLink System in selected European markets, including Belgium, France, Germany and the UK. The PowerLink...

Misys Healthcare Systems (Raleigh, North Carolina) and Midmark Diagnostics Group (Torrance, California) have formed an alliance that will enable physicians to integrate data from Midmark's diagnostic measurement devices into Misys EMR, Misys' electronic medical records solution.(Agreements)(Brief Article)
May 1, 2004... Misys Healthcare Systems (Raleigh, North Carolina) and Midmark Diagnostics Group (Torrance, California) have formed an alliance that will enable physicians to integrate data from Midmark's diagnostic measurement devices into Misys EMR, Misys'...

Novare Surgical Systems (Cupertino, California), a privately held provider of devices for cardiovascular and vascular surgery, has formed an exclusive distribution agreement with Medtronic (Minneapolis, Minnesota) for Novare's Enclose II Cardiac Anastomosis Assist Device used in off-pump and on-pump coronary artery bypass graft (CABG) surgery.(Agreements)(Brief Article)
May 1, 2004... Novare Surgical Systems (Cupertino, California), a privately held provider of devices for cardiovascular and vascular surgery, has formed an exclusive distribution agreement with Medtronic (Minneapolis, Minnesota) for Novare's Enclose II...

Third Wave Technologies (Madison, Wisconsin) and Innogenetics NV (Gent, Belgium) have signed a four-year marketing and distribution agreement.(Agreements)(Brief Article)
May 1, 2004... Third Wave Technologies (Madison, Wisconsin) and Innogenetics NV (Gent, Belgium) have signed a four-year marketing and distribution agreement. Under the terms of the agreement, Third Wave has granted Innogenetics the exclusive European...

'Off-pump,' traditional CABG seen equivalent.(Market Updates)(coronary artery bypass graft)
May 1, 2004... Bypass surgery done on a beating heart is just as effective as the conventional operation performed with a heart-lung machine, and less expensive, according to a study reported last month. Results of the SMART (Surgical Management of Arterial...

Feigal leaves post as CDRH director.(Market Updates)(Center for Devices and Radiological Health)(David Feigal Jr.)
May 1, 2004... David Feigal Jr., MD, last month resigned as director of the FDA's Center for Devices and Radiological Health (CDRH), a post he had held since 1999. After initially indicating he would be seeking an academic position in Arizona, where his wife...

Abiomed.(Personnel File)(Brief Article)
May 1, 2004... Gary Stickel has joined Abiomed (Danvers, Massachusetts) as vice president of human resources and development. Stickel previously was vice president of human resources at Segue Software. Abiomed is a manufacturer of devices designed to assist...

Enpath Medical.(Personnel File)(Brief Article)
May 1, 2004... Enpath Medical (Minneapolis, Minnesota), a developer of percutaneous delivery systems and stimulation lead technologies, has formed a sales and marketing department that combines and coordinates the activities of its two divisions, Delivery...

ePocrates.(Personnel File)(Brief Article)
May 1, 2004... Robert McCulloch has been named chief financial officer of ePocrates (San Mateo, California). He most recently served as CFO of CardioVention. ePocrates provides clinical information to physicians and other healthcare professionals at the point...

Edwards Lifesciences.(Personnel File)(Brief Article)
May 1, 2004... John Alexander Martin has joined Edwards Lifesciences (Irvine, California) as president of its North America region. He previously was with Cordis, a Johnson & Johnson company, where he most recently served as senior vice president,...

Heartbeat Digital.(Personnel File)(Brief Article)
May 1, 2004... Else-Marie Ostling has joined Heartbeat Digital (New York) as managing director and vice president of technology. She formerly was global chief technology officer of IconMedialab and will be based at Heartbeat Digital's development office in...

Ventracor.(Personnel File)(Brief Article)
May 1, 2004... Ventracor (Sydney, Australia) has named Vanio Calgaro financial controller. He previously was Financial controller and company secretary with Peptech, Victor Windeyer has been named VentrAssist program manager. He previously was program manager...

Panel urges OK of carotid stent system.(Product Pipeline)
May 1, 2004... The carotid artery stent system from Cordis Endovascular (Miami Lakes, Florida) is one step closer to approval by the FDA. At a meeting on April 21, the Circulatory System Devices Panel of the agency's Center for Devices and Radiological Health...

AngioDynamics (Queensbury, New York), a wholly owned subsidiary of E-Z-EM, reported the worldwide market launch of the SpeedLyser Thrombolytic catheter, a catheter kit intended for the administration of thrombolytic agents into the peripheral vasculature.(Product Pipeline)(Brief Article)
May 1, 2004... AngioDynamics (Queensbury, New York), a wholly owned subsidiary of E-Z-EM, reported the worldwide market launch of the SpeedLyser Thrombolytic catheter, a catheter kit intended for the administration of thrombolytic agents into the peripheral...

ATS Medical.(Product Pipeline)(Brief Article)
May 1, 2004... ATS Medical (Minneapolis, Minnesota) said the intermediate-term clinical performance of the ATS Open Pivot Heart Valve was the subject of a study published recently in the Journal of Heart Valve Disease. The authors observed, "This report......

Biomed Research (Tampa, Florida) reported completion of ergonomic refinements to its MedClose Internal Puncture Closure device.(Product Pipeline)(Brief Article)
May 1, 2004... Biomed Research (Tampa, Florida) reported completion of ergonomic refinements to its MedClose Internal Puncture Closure device. The MedClose is a catheter-based debridement and biological glue delivery system designed to rapidly seal arterial...

Boston Scientific.(Product Pipeline)(Brief Article)
May 1, 2004... Boston Scientific (Natick, Massachusetts) reported 30-day safety data from its clinical trial to evaluate the benefits of stenting in conjunction with embolic protection for the treatment of carotid artery disease at the recent Peripheral...

CardioDynamics.(Product Pipeline)(Brief Article)
May 1, 2004... CardioDynamics (San Diego, California) reported publication of seven peer-reviewed articles in Congestive Heart Failure March/April 2004 supplement. The articles demonstrate the accuracy of the company's Impedance Cardiography (ICG) technology...

Cardiome Pharma.(Product Pipeline)(Brief Article)
May 1, 2004... Cardiome Pharma (Vancouver, British Columbia) said its independent Data Safety Monitoring Board recommended the company continue its ACT 1 Phase III trial, which is evaluating intravenous RSD1235 for acute atrial fibrillation and atrial...

CardioTech International (Wilmington, Massachusetts) said its wholly owned subsidiary, Gish Biomedical (Rancho Santa Margarita, California), has received FDA clearance to sell the Vision Blood Cardioplegia (VBC) System with GBS (Gish Biocompatible Surface) blood compatible coating in conjunction with Gish's line of heart bypass products.(Product Pipeline)(Brief Article)
May 1, 2004... CardioTech International (Wilmington, Massachusetts) said its wholly owned subsidiary, Gish Biomedical (Rancho Santa Margarita, California), has received FDA clearance to sell the Vision Blood Cardioplegia (VBC) System with GBS (Gish...

CardioVations (Somerville, New Jersey), a division of Ethicon, a Johnson & Johnson (New Brunswick, New Jersey) company, reported the latest advancement to its line of heart stabilization systems.(Product Pipeline)(Brief Article)
May 1, 2004... CardioVations (Somerville, New Jersey), a division of Ethicon, a Johnson & Johnson (New Brunswick, New Jersey) company, reported the latest advancement to its line of heart stabilization systems. The Embrace Heart Stabilizer stabilizes desired...

A team of physicians at Thomas Jefferson University Hospital (Philadelphia, Pennsylvania) completed the first U.S. placement of the Zenith TX2 Thoracic TAA Endovascular Graft under the device's pivotal U.S. clinical trial sponsored by Cook (Bloomington, Indiana).(Product Pipeline)
May 1, 2004... A team of physicians at Thomas Jefferson University Hospital (Philadelphia, Pennsylvania) completed the first U.S. placement of the Zenith TX2 Thoracic TAA Endovascular Graft under the device's pivotal U.S. clinical trial sponsored by Cook...

Cordis.(Product Pipeline)(Cypher)(Brief Article)
May 1, 2004... Patient enrollment is under way in a significant new registry that will evaluate the impact of stent-deployment technique on patient outcomes using the Cypher sirolimus-eluting stent distributed by Cordis (Miami Lakes, Florida). The eCYPHER...

Edwards Lifesciences (Irvine, California) reported the first implant of its Carpentier-Edwards Perimount Magna replacement tissue heart valve that also features its newly approved ThermaFix tissue process, which is designed to greatly reduce tissue valve calcification.(Product Pipeline)(Brief Article)
May 1, 2004... Edwards Lifesciences (Irvine, California) reported the first implant of its Carpentier-Edwards Perimount Magna replacement tissue heart valve that also features its newly approved ThermaFix tissue process, which is designed to greatly reduce...

EndoBionics.(Product Pipeline)(Brief Article)
May 1, 2004... EndoBionics (San Leandro, California) reported that the FDA has approved marketing of the company's MicroSyringe catheter for the infusion of therapeutic and diagnostic agents that are indicated for delivery into the vessel wall or perivascular...

Guidant.(Product Pipeline)(Brief Article)
May 1, 2004... Guidant (Indianapolis, Indiana) reported completion of enrollment in SPIRIT FIRST, a clinical trial evaluating its second drug-eluting stent system for the treatment of coronary artery disease. The trial compares an everolimus-eluting stent...

Kensey Nash.(Product Pipeline)(Brief Article)
May 1, 2004... Kensey Nash (Exton, Pennsylvania) said enrollment has been completed in the randomized trial of its TriActiv Balloon Protected Flush Extraction System. The PRIDE (PRotection during saphenous vein graft Intervention to prevent Distal...

MedicalCV.(Product Pipeline)(Brief Article)
May 1, 2004... MedicalCV (Inver Grove Heights, Minnesota) reported that it has filed a 510(k) application with the FDA for approval to market the Atrilaze Soft Tissue Ablation System. The laser device will be used to ablate or cause scarring of soft tissue,...

Medtronic.(Product Pipeline)(Brief Article)
May 1, 2004... Medtronic (Minneapolis, Minnesota) reported the U.S. commercial release of two electrophysiology catheters, the EnCirclr AL Adjustable Loop Mapping Catheter and the RF Enhancer II Single-Curve Ablation Catheter. The EnCirclr AL mapping catheter...

Medstat (Ann Arbor, Michigan), a business of Thomson Healthcare, publisher of Cardiovascular Device Update, and ECRI (Plymouth Meeting, Pennsylvania), a nonprofit international health services research agency, reported creation of an expanded and enhanced database that enables healthcare organizations to assess the impact of emerging medical technologies.(Product Pipeline)(Brief Article)
May 1, 2004... Medstat (Ann Arbor, Michigan), a business of Thomson Healthcare, publisher of Cardiovascular Device Update, and ECRI (Plymouth Meeting, Pennsylvania), a nonprofit international health services research agency, reported creation of an expanded...

MicroMed Technology (Houston, Texas) said a six-year-old patient at Texas Children's Hospital (also Houston) became the first pediatric patient in the world to receive its DeBakey child ventricular assist device (VAD), approved by the FDA for use in children via a Humanitarian Device Exemption (HDE).(Product Pipeline)(Brief Article)
May 1, 2004... MicroMed Technology (Houston, Texas) said a six-year-old patient at Texas Children's Hospital (also Houston) became the first pediatric patient in the world to receive its DeBakey child ventricular assist device (VAD), approved by the FDA for...

MIV Therapeutics.(Product Pipeline)(Brief Article)
May 1, 2004... MIV Therapeutics (MIVT; Vancouver, British Columbia) reported that its Hydroxyapatite (Hap) ultra-thin coating technology has successfully passed the Systemic Injection Test, which the company said is an important milestone on the path to...

PLC Systems (Franklin, Massachusetts) reported that a cardiac surgical team from Good Samaritan Hospital (Cincinnati, Ohio) has completed the first carbon dioxide (C[O.sub.2]) transmyocardial revascularization (TMR) procedure with robotic assistance.(Product Pipeline)(Brief Article)
May 1, 2004... PLC Systems (Franklin, Massachusetts) reported that a cardiac surgical team from Good Samaritan Hospital (Cincinnati, Ohio) has completed the first carbon dioxide (C[O.sub.2]) transmyocardial revascularization (TMR) procedure with robotic...

Quinton Cardiology Systems.(Product Pipeline)(Brief Article)
May 1, 2004... Quinton Cardiology Systems (Bothell, Washington) reported that it has started shipping networked versions of its Q-Tel RMS. Q-Tel is a comprehensive, dedicated cardiac rehabilitation management system allowing clinicians and administrators to...