Cardiovascular Device Update articles from September 2003

Cardiovascular Device Update archives from September 2003

Cardiology sector sees advances in laboratory and POC testing.(point-of-care)
September 1, 2003... PHILADELPHIA, Pennsylvania -- New cardiac markers such as troponin I, troponin T and, most recently, B-type natriuretic peptide (BNP) and proBNP, have revolutionized the diagnosis of myocardial infarction and heart failure in the emergency...

Stroke prevention devices in 'Summer in Seattle' spotlight: CDU at the Summer in Seattle conference.(Washington)
September 1, 2003... SEATTLE, Washington -- Beginning with the advent of percutaneous transluminal coronary angioplasty (PTCA) about 20 years ago, the interventional cardiology (IC) market has grown rapidly, fueled by relentless and impressive innovation. This has...

Necessity drives new use for CardioTech's synthetic graft.
September 1, 2003... As is often the case with science-based medicine, many great discoveries are made entirely by accident or out of an urgent necessity. Falling into the latter category was CardioTech International's (Woburn, Massachusetts) first pediatric...

Eucomed boosts CRT vs. drugs in HF care: a CDU staff report.(Report from Europe)(cardiac resynchronization therapy, heart failure)(Brief Article)
September 1, 2003... Eucomed (Brussels, Belgium), the European medical technology trade association, has developed a computerized health economic model to explore the cost-effectiveness of cardiac resynchronization therapy (CRT) as compared to traditional...

Chief executive named for UK agency.(Report from Europe)(Medicines and Healthcare Products Regulatory Agency, United Kingdom)(Brief Article)
September 1, 2003... The appointment of a chief executive for the UK's newly established Medicines and Healthcare Products Regulatory Agency (MHRA) was reported by the Department of Health late last month. Kent Woods, professor of therapeutics at the University of...

Special-interest GP program grows.(Report from Europe)(general practitioners)(Brief Article)
September 1, 2003... The UK Department of Health said there are now more than 1,000 general practitioners (GPs) with a special interest in treating patients in England. That achieves a target set in the NHS Plan one year ahead of schedule. Health Minister Rosie...

Guidant's (Indianapolis, Indiana) Vascular Intervention division (Santa Clara, California) has acquired the right to use certain bioabsorbable polymer technologies developed by MediVas (San Diego, California), a firm that primarily focuses on developing technologies for diagnosis and treatment of cardiovascular diseases.(Acquisitions)(Brief Article)
September 1, 2003... * Guidant's (Indianapolis, Indiana) Vascular Intervention division (Santa Clara, California) has acquired the right to use certain bioabsorbable polymer technologies developed by MediVas (San Diego, California), a firm that primarily focuses on...

MedicalCV (Inner Grove Heights, Minnesota), a cardiothoracic surgery device manufacturer, has signed an agreement to acquire a technology platform for the treatment of atrial fibrillation.(Acquisitions)(Brief Article)
September 1, 2003... * MedicalCV (Inner Grove Heights, Minnesota), a cardiothoracic surgery device manufacturer, has signed an agreement to acquire a technology platform for the treatment of atrial fibrillation (AF) from LightWave Ablation Systems (Mooresville,...

Medtronic (Minneapolis, Minnesota) has executed an agreement to purchase substantially all of the assets of TransVascular (Palo Alto, California), a privately held company that has developed a proprietary platform delivery technology for several current and potential intravascular procedures, including the ability to deliver therapeutic agents, including cells, genes and drugs to precise locations within the vascular architecture.(Acquisitions)
September 1, 2003... * Medtronic (Minneapolis, Minnesota) has executed an agreement to purchase substantially all of the assets of TransVascular (Palo Alto, California), a privately held company that has developed a proprietary platform delivery technology for...

PDSHeart (Conyers, Georgia), a cardiac telemedicine provider, has acquired the cardiac event monitoring business of Navix Diagnostix (Taunton, Massachusetts).(Acquisitions)(Brief Article)
September 1, 2003... * PDSHeart (Conyers, Georgia), a cardiac telemedicine provider, has acquired the cardiac event monitoring business of Navix Diagnostix (Taunton, Massachusetts). The purchase expands the company's business in the Northeast, Midwest and Texas, as...

Roche Diagnostics (Basel, Switzerland) and SYN X Pharma (Toronto, Ontario) reported that SYN X has been granted a non-exclusive worldwide license under patent rights of Roche Diagnostics.(Acquisitions)(Brief Article)
September 1, 2003... * Roche Diagnostics (Basel, Switzerland) and SYN X Pharma (Toronto, Ontario) reported that SYN X has been granted a non-exclusive worldwide license under patent rights of Roche Diagnostics relating to the development, manufacture and marketing...

Novoste cuts jobs, suspends MOBILE.(Business Developments)(MOre Patency with Beta In the Lower Extremity)
September 1, 2003... Novoste (Norcross, Georgia), a specialist in brachytherapy technology for the prevention of instent restenosis, reported last month that it would lay off 50 employees, mostly at its Norcross location, in ongoing moves to cut costs and...

Panel upholds payment to Cordis.(Business Developments)
September 1, 2003... Johnson & Johnson (J&J; New Brunswick, New Jersey) reported last month that an arbitration panel in Chicago, Illinois, has upheld its preliminary findings, issued June 5, that Guidant's (Indianapolis, Indiana) Multi-Link Duet Coronary Stent...

Possis halts Phase I stroke trial.(Business Developments)
September 1, 2003... Possis Medical (Minneapolis, Minnesota) has ended its Phase 1 TIME (Thrombectomy in Middle Cerebral Embolism) clinical trial for ischemic stroke after study investigators decided that the company's device, the Angiojet NV 150 neurocatheter, did...

Tenet to pay $54M in heart surgery probe.(Business Developments)(Brief Article)
September 1, 2003... Tenet HealthCare (Santa Barbara, California) will pay $54 million in what the U.S. government is calling the largest-ever settlement involving allegations of unnecessary surgeries, stemming from an investigation at a Tenet hospital in Northern...

Ventracor sets $33 million rights issue.(Business Developments)(Brief Article)
September 1, 2003... Assistive heart pump developer Ventracor (Sydney, Australia) reported the terms of a proposed rights issue to shareholders to raise about $33 million. The renounceable rights issue will be on the basis of 1 new share for every 12 shares held at...

Cardiac Science (Irvine, California) and GE Medical Systems Information Technologies (GEMSIT; Milwaukee, Wisconsin) have signed multi-year strategic OEM, distribution and development agreements, under which GE will market Cardiac Science automated external defibrillators (AEDs) and fully-automatic in-hospital defibrillator-monitors (CRMs) under the GE name in Europe, Asia, the Middle East and other international markets.(Agreements)(Brief Article)
September 1, 2003... * Cardiac Science (Irvine, California) and GE Medical Systems Information Technologies (GEMSIT; Milwaukee, Wisconsin) have signed multi-year strategic OEM, distribution and development agreements, under which GE will market Cardiac Science...

Happy Valley Medical (San Diego, California) has entered into a research alliance with Edwards Lifesciences (Irvine, California) to evaluate the anti-proliferative and anti-restenotic properties of C6-ceramide in the peripheral vasculature.(Agreements)(Brief Article)
September 1, 2003... * Happy Valley Medical (San Diego, California) has entered into a research alliance with Edwards Lifesciences (Irvine, California) to evaluate the anti-proliferative and anti-restenotic properties of C6-ceramide in the peripheral vasculature....

Quinton Cardiology Systems (Bothell, Washington) and Cambridge Heart (Bedford, Massachusetts) reported an agreement in which Quinton will continue to promote and distribute a fully integrated version of Cambridge Heart's MTWA technology in its Burdick brand stress systems.(Agreements)(Brief Article)
September 1, 2003... * Quinton Cardiology Systems (Bothell, Washington) and Cambridge Heart (Bedford, Massachusetts) reported an agreement in which Quinton will continue to promote and distribute a fully integrated version of Cambridge Heart's MTWA technology in...

Zoll Medical (Chelmsford, Massachusetts) and Revivant (Sunnyvale, California) reported an agreement aimed at the commercialization of Revivant's AutoPulse cardiopulmonary resuscitation (CPR) product.(Agreements)(Brief Article)
September 1, 2003... * Zoll Medical (Chelmsford, Massachusetts) and Revivant (Sunnyvale, California) reported an agreement aimed at the commercialization of Revivant's AutoPulse cardiopulmonary resuscitation (CPR) product. The AutoPulse, a new FDA-approved portable...

Cost and competition keys to drug/stent use.(Market Updates)
September 1, 2003... Endovascular physicians and interventional cardiologists are overwhelmingly likely to use drug-eluting stents (DES) more often in the future because they believe their costs will decrease as competition among manufacturers increases. That's the...

Independent reports support DES use.(Market Updates)(drug-eluting stents)
September 1, 2003... The assumption of superiority of drug-coated stents over bare-metal stents was underlined still further the week prior to this month's Transcatheter Cardiovascular Therapeutics conference with the release of two independent reports likely to...

Stem-cell technology: cardiac tissue fix?(Market Updates)
September 1, 2003... Stem cells can help cardiac tissue to repair itself weeks after a heart attack, new research being conducted at the Cleveland Clinic (Cleveland, Ohio) suggests. The study identified the first stem cell "homing factor" for cardiac muscle tissue,...

Risk scoring newest aid for AF.(Market Updates)(atrial fibrillation )
September 1, 2003... Now patients with new onset of atrial fibrillation can be scored to estimate the risk of stroke or death, which could lead to appropriate treatments being administered earlier, according to a new research study. The classification system, which...

CABG Medical.(Personnel File)(Brief Article)
September 1, 2003... John Babitt has been named president, chief operating officer and chief financial officer of CABG Medical (Minneapolis, Minnesota). Babbitt previously was an executive with BioHeart. CABG Medical develops coronary bypass devices and related...

Hiemstra Product Development.(Personnel File)(Brief Article)
September 1, 2003... James Flom has been named to the new post of vice president, research and development for Hiemstra Product Development (San Francisco, California), a provider of product development consulting services for the device industry. He has been...

Robert Schultz, PhD, currently executive vice president and general manager of REVA Medical (San Diego, California), has been named president for both REVA and its sister company, Happy Valley Medical.(Personnel File)(Brief Article)
September 1, 2003... Robert Schultz, PhD, currently executive vice president and general manager of REVA Medical (San Diego, California), has been named president for both REVA and its sister company, Happy Valley Medical. Schultz replaces early investor and...

Edwards launches its embolic filter in U.S.(Product Pipeline)
September 1, 2003... A new filter device designed to capture the emboli and aortic plaque caused by cross-clamping of the aorta during a cardiopulmonary bypass procedure began commercial launch in the U.S. last month, and could potentially benefit hundreds of...

Alexion Pharmaceuticals.(Product Pipeline)(Brief Article)
September 1, 2003... Alexion Pharmaceuticals (Cheshire, Connecticut) reported preliminary results of its Phase III study in a large, multinational trial consisting of more than 3,000 patients undergoing coronary artery bypass graft (CABG) surgery with...

Biosite.(Product Pipeline)
September 1, 2003... * Biosite (San Diego, California) reported the start of the RABBIT (Rapid Assessment of Bedside BNP in Treatment of congestive heart failure) clinical trial, which is designed to evaluate measurements of b-type natriuretic peptide (BNP) in...

Boston Scientific.(Product Pipeline)(Brief Article)
September 1, 2003... * Boston Scientific (Natick, Massachusetts) reported the launch of its intravascular ultrasound (IVUS) imaging system, the Galaxy 2 System. The system is now available in the U.S. and Canada, and scheduled to be available in Europe and Japan...

Cardima (Fremont, California) has initiated its marketing campaign for the newest addition to its Revelation family of linear ablation catheters, the Revelation Helix STX 2.5, or "large loop" version of the Revelation Helix in Europe.(Product Pipeline)(Brief Article)
September 1, 2003... * Cardima (Fremont, California) has initiated its marketing campaign for the newest addition to its Revelation family of linear ablation catheters, the Revelation Helix STX 2.5, or "large loop" version of the Revelation Helix in Europe. The...

Cardiome Pharma.(Product Pipeline)
September 1, 2003... * Cardiome Pharma (Vancouver, British Columbia) said it has begun patient dosing in its initial Phase III efficacy study of RSD1235 for the acute treatment of atrial fibrillation. The initial study, called ACT 1 (Atrial fibrillation Conversion...

Digirad.(Product Pipeline)(Brief Article)
September 1, 2003... * Digirad (San Diego, California) reported the release of what it said is the first upgradable nuclear gamma camera available on the market. Cardius -1 is a solid-state nuclear gamma camera with a single detector that is dedicated exclusively...

LuMend.(Product Pipeline)(Brief Article)
September 1, 2003... * LuMend (Redwood City, California) reported the launch of its Frontrunner Micro Guide Catheter (MGC). The MGC is used in conjunction with the recently launched .039" Frontrunner X39 CTO Catheter. Both devices are FDA-cleared to treat CTOs...

Masimo.(Product Pipeline)(Brief Article)
September 1, 2003... * Masimo (Irvine, California), a developer of motion and low-perfusion tolerant pulse oximetry, reported the publication of a study in the March issue of Pediatrics indicating pulse oximetry as a useful diagnostic device in screening infants...

Medtronic (Minneapolis, Minnesota) reported full U.S. availability of the company's NC Stormer high-pressure, non-compliant balloon dilatation catheter.(Product Pipeline)
September 1, 2003... * Medtronic (Minneapolis, Minnesota) reported full U.S. availability of the company's NC Stormer high-pressure, non-compliant balloon dilatation catheter. The balloon is now available on both Medtronic's Zipper Multi-Exchange (MX) and...

Spectranetics.(Product Pipeline)(Brief Article)
September 1, 2003... * Spectranetics (Colorado Springs, Colorado) said that the FDA approved a labeling change for its excimer laser coronary atherectomy catheters that allows individualization of use for treatment of patients with acute myocardial infarction,...

St. Jude Medical.(Product Pipeline)(Brief Article)
September 1, 2003... * St. Jude Medical (St. Paul, Minnesota) reported the initiation and first patient enrollment in the ASSIST (Atrial Tachyarrhythmia Suppression Strategy in ICD Subjects Trial) clinical study. The purpose of the ASSIST study is to evaluate if...

SYN X Pharma (Toronto, Ontario) said that the company received the CE mark to sell its Nexus Dx point-of-care cardiac product line in Europe.(Product Pipeline)
September 1, 2003... * SYN X Pharma (Toronto, Ontario) said that the company received the CE mark to sell its Nexus Dx point-of-care cardiac product line in Europe. SYN X currently has Health Canada approval and is selling and distributing the tests through its...

Thoratec.(Product Pipeline)(Brief Article)
September 1, 2003... * Thoratec (Pleasanton, California) said it has received European marketing approval for the Thoratec WAD, an implantable heart pump that helps support one or both chambers of the heart. The device is a smaller, implantable version of the...

Ventracor (Sydney, Australia) said that medical investigators in Australia have provided a progress report on the clinical trial of its left ventricular assist system (LVAS) at The Alfred Hospital (Melbourne, Australia).(Product Pipeline)(Brief Article)
September 1, 2003... * Ventracor (Sydney, Australia) said that medical investigators in Australia have provided a progress report on the clinical trial of its left ventricular assist system (LVAS) at The Alfred Hospital (Melbourne, Australia). The VentrAssist is a...

World Heart.(Product Pipeline)(Brief Article)
September 1, 2003... * World Heart (Ottawa, Ontario) said it has provided the FDA with an amended submission in response to the agency's request for additional data and statistical analyses as part of its expedited review of the company's Destination Therapy...