Cardiovascular Device Update articles from March 2003

Cardiovascular Device Update archives from March 2003

Changing role for cardiac surgery as use of stents continues growth.(minimally invasive surgery phases out coronary artery bypass and heart valve replacement)
March 1, 2003... SAN DIEGO, California -- The 39th annual meeting of the Society of Thoracic Surgeons (STS; Chicago, Illinois), held here in early February, along with the STS/AATS Tech-Con conference, provided a window to the changing role of surgery in the...

At presstime.(cardiac re synchronization system approved)(Brief Article)
March 1, 2003... Medtronic (Minneapolis, Minnesota) said Feb. 26 that the FDA had given its approval to the company's latest cardiac resynchronization system, the InSync III.

CardioGenesis reports impressive results. (Society of Thoracic Surgeons).(CardioGenesis Inc.)(long term efficacy of transmyocardial revascularization products)
March 1, 2003... SAN DIEGO, California -- When introduced to the U.S. market in the summer of 1998, many industry observers expected that transmyocardial revascularization (TMR) would be adopted rapidly by the cardiac surgery community. For a variety of...

Heart graft of cells survived 18 months. (Report from Europe).(transplanting skeletal cell muscles into the heart)
March 1, 2003... A team of French physicians said it has proof of principle that autologous cell therapy is a viable treatment for myocardial infarction. A post-mortem study carried out on one of 10 patients to receive the experimental treatment showed that the...

EU medicines directive can affect coated stents. (Report from Europe).(European Union)(defining medicinal products)(Brief Article)
March 1, 2003... At the European Commission in Brussels, Belgium, there may be changes in definitions of "medicinal products" which could alter the status of existing medical devices such as heart valves, stents and catheters which incorporate biological...

New CAD therapy. (Report from Europe).(coronary artery disease)(angiogenic gene therapy)(Brief Article)
March 1, 2003... Schering (Berlin, Germany), together with its Collateral Therapeutics (San Diego, California) subsidiary, is developing intracoronary angiogenic gene delivery as a novel therapy for the treatment of coronary artery disease (CAD) in cases when...

Balloon angioplasty in Denmark. (Report from Europe).(balloon angioplasty better than thrombolytic therapy)(Brief Article)
March 1, 2003... The DANAMI study in Denmark showed that there were greater benefits from transporting a coronary thrombosis patient up to 150 kilometers to a specialized cardiac center that could perform balloon angioplasty, in comparison with admitting the...

New hemocompatible coatings. (Report from Europe).(preventing restenosis)(Brief Article)
March 1, 2003... Hemoteq (Wurselen, Germany) has developed a drug-eluting system, Ouverture, which combines hemocompatibility with the prevention of restenosis and which consists of two coatings. The first is Repulsion, a coating with a matrix for the...

Gendel uses blood cells for drug delivery. (Report from Europe).(Brief Article)
March 1, 2003... A spin-off in 1998 from the University of Ulster (Ulster, Northern Ireland), Gendel (Coleraine, Northern Ireland) is working on the delivery of drugs to specific sites in the human body by using the red blood cells as a carrier. "The cell...

Caffeine does not increase blood pressure. (Report from Europe).(Brief Article)
March 1, 2003... There is considerable controversy as to whether caffeine affects blood pressure levels. Robert Coti at University Hospital (Zurich, Switzerland) has investigated the effect of normal or decaffeinated coffee on blood pressure. Students taking...

Minisensor warns of MI risks. (Report from Europe).(myocardial infarction)(Brief Article)
March 1, 2003... Researchers at the University of Basel (Basel, Switzerland) have collaborated with the IBM Research Laboratory in Zurich to develop a sensor for two blood proteins as biomarkers for an increased risk of myocardial infarction (MI). The...

New indications for Plavix. (Report from Europe).(clopidogrel hydrosulfate approved for heart attack treatment)(Brief Article)
March 1, 2003... Sanofi-Synthelabo (Paris) reported obtaining in the U.S. and Europe clearance for Plavix/Iscover (clopidogrel hydrosulfate) for therapeutic use in patients suffering from an acute coronary syndrome (myocardial infarct without Q wave). The...

Angiotech Pharmaceuticals (Vancouver, British Columbia) reported completing its purchase of biomaterials engineering and biosurgical products manufacturer Cohesion Technologies (Palo Alto, California). (Acquisitions).(Angiotech Pharmaceuticals Inc.)(Cohesion Technologies Inc.)(Brief Article)
March 1, 2003... * Angiotech Pharmaceuticals (Vancouver, British Columbia) reported completing its purchase of biomaterials engineering and biosurgical products manufacturer Cohesion Technologies (Palo Alto, California). Initially announced last September, the...

CardioTech International (Woburn, Massachusetts) said the SEC declared effective its registration statement on Form S-4 in connection with its proposed acquisition of Gish Biomedical (Rancho Santa Margarita, California) via a stock swap. (Acquisitions).(CardioTech International Inc.)(Securities and Exchange Commisson)(Gish Biomedical Inc.)(Brief Article)
March 1, 2003... * CardioTech International (Woburn, Massachusetts) said the SEC declared effective its registration statement on Form S-4 in connection with its proposed acquisition of Gish Biomedical (Rancho Santa Margarita, California) via a stock swap. The...

Edwards Lifesciences (Irvine, California) reported the acquisition of the percutaneous mitral valve repair program of Jomed NV (Beringen, Switzerland), a provider of products for minimally invasive vascular intervention, for about $20 million. (Acquisitions).(Brief Article)
March 1, 2003... * Edwards Lifesciences (Irvine, California) reported the acquisition of the percutaneous mitral valve repair program of Jomed NV (Beringen, Switzerland), a provider of products for minimally invasive vascular intervention, for about $20...

PLC, Medtronic in stroke therapy trials. (Business Developments).(PLC Systems Inc.)(Medtronic Inc.)
March 1, 2003... The cardiovascular field last month saw the unveiling of a couple of significant new developments in the cardiovascular arena, one a study for a combination medical device/biotechnology therapy for the enhancement of revascularization and the...

Digital Angel (South St. Paul, Minnesota) said it is working closely with the University of California at Riverside School of Engineering to accelerate the integration of medical and environmental biosensor technologies into its expanding line of wireless communications devices. (Agreements).(Digital Angel Corp.)(Brief Article)
March 1, 2003... * Digital Angel (South St. Paul, Minnesota) said it is working closely with the University of California at Riverside School of Engineering to accelerate the integration of medical and environmental biosensor technologies into its expanding...

Global Medical Products Holdings (GMPH; Laguna Hills, California) said its ECOM Shanghai International Trading Co. subsidiary has signed a distribution agreement with B. Braun Medical Ltd. (Sheffield, UK). (Agreements).(Brief Article)
March 1, 2003... * Global Medical Products Holdings (GMPH; Laguna Hills, California) said its ECOM Shanghai International Trading Co. subsidiary has signed a distribution agreement with B. Braun Medical Ltd. (Sheffield, UK). The agreement provides to ECOM the...

Teknor Apex (Pawtucket, Rhode Island) and polyvinyl chloride (PVC) manufacturer Vestolit GmbH and Co. (Marl, Germany) signed an agreement that grants Teknor Apex exclusive worldwide rights to develop and produce vinyl compounds based on new copolymers with blood clot-preventing molecules incorporated directly into the PVC polymer backbone. (Agreements).(Teknor Apex Co.)(Brief Article)
March 1, 2003... * Teknor Apex (Pawtucket, Rhode Island) and polyvinyl chloride (PVC) manufacturer Vestolit GmbH & Co. (Marl, Germany) signed an agreement that grants Teknor Apex exclusive worldwide rights to develop and produce vinyl compounds based on new...

Zargis Medical (Princeton, New Jersey), which is developing an acoustic signal processing technology for the screening and diagnosis of congenital and valvular heart disease, has signed a licensing agreement with Johns Hopkins University (JHU; Baltimore, Maryland) and its Applied Physics Laboratory (APL). (Agreements).(Brief Article)
March 1, 2003... * Zargis Medical (Princeton, New Jersey), which is developing an acoustic signal processing technology for the screening and diagnosis of congenital and valvular heart disease, has signed a licensing agreement with Johns Hopkins University...

Medicare panel backs expanded use of ICDs. (Market Updates).(implantable cardioverter defibrillators to be covered by Medicare)
March 1, 2003... A Medicare advisory panel recommendation to cover implantable cardioverter defibrillators (ICDs) could be a major victory for companies such as Guidant (Indianapolis, Indiana), Medtronic (Minneapolis; Minnesota) and St. Jude Medical (St. Paul,...

FDA plans to speed device development. (Market Updates).(Food and Drug Administration)(reducing development costs of medical technology)
March 1, 2003... The FDA last month unveiled an agency-wide initiative to make medical technologies available sooner and reduce the costs of developing safe and effective medical products. The effort involves all four FDA product review centers: drugs,...

Grim outlook for NIH in Bush budget. (Market Updates).(National Institutes of Health)(President George W. Bush cuts health finance)
March 1, 2003... Medicare is expected to get a makeover, but the National Institutes of Health (NIH; Bethesda, Maryland) could face grim years ahead based on President George Bush's 2004 budget, presented to Congress last month. The $2.23 trillion federal...

Nasdaq looks to ease rules. (Market Updates).(Nasdaq Stock Market Inc. to relax its bid requirements)
March 1, 2003... Aiming to help companies that trade their securities at depressed prices on its exchange, the Nasdaq Stock Market (New York) is working to relax its bid requirements. On Jan. 30, Nasdaq said it planned to extend a pilot program governing...

Angiotech Pharmaceuticals. (Personnel File).(Angiotech Pharmaceuticals Inc. selects new vice presidents)(Brief Article)
March 1, 2003... * George Daniloff, MD, PhD, has been named general manager and vice president of research and development of the California facility of Angiotech Pharmaceuticals (Vancouver, British Columbia). Ross Erickson has been named vice president,...

Endocardial Solutions. (Personnel File).(Endocardial Solutions Inc. selects new vice president of sales)(Brief Article)
March 1, 2003... * Patrick Wethington has been promoted from areas sales director of the northern and central sales territories for Endocardial Solutions (Minneapolis, Minnesota) to vice president, North American sales. Endocardial Solutions manufactures...

Paracor Surgical. (Personnel File).(new president and chief executive officer at Paracor Surgical)(Brief Article)
March 1, 2003... * William Mavity has been appointed president and chief executive officer of Paracor Surgical (Sunnyvale, California). Mavity most recently served as CEO and director of Cohesion Technologies. Paracor is a development-stage company focused on...

Possis Medical. (Personnel File).(vice president of Possis Medical Inc. resigns)(Brief Article)
March 1, 2003... * T.V. Rao, vice president of worldwide sales and marketing at Possis Medical (Minneapolis, Minnesota), will retire from the firm effective April 4. Possis makes devices for the removal of blood clots from coronary arteries and bypass grafts,...

Abbott is 3rd player in coated-stent arena. (Product Pipeline).(Abbott Laboratories)
March 1, 2003... A third player has entered the drug-eluting stent sector in Europe, though the company claims it was really the second firm to earn the CE mark. While that may be the case, the real question may be the device's speed of entry to U.S. launch....

Abiomed. (Product Pipeline).(ABIOMED Inc. patents heart wrap device)(Brief Article)
March 1, 2003... * Abiomed (Danvers, Massachusetts) reported issuance of a new patent that significantly enhances the company's intellectual property portfolio in the area of active and passive heart wrap devices. Heart wrap devices represent a promising...

Advanced Stent Technologies. (Product Pipeline).(Advanced Stent Technologies Inc. markets stent and delivery system)(Brief Article)
March 1, 2003... * Advanced Stent Technologies (AST; Pleasanton, California) said that it has received CE mark approval to market its SLK-View DSX Stent and Delivery System to treat cardiovascular disease at bifurcation points in the coronary vascular system....

Angiotech Pharmaceuticals (Vancouver, British Columbia) said it received FDA approval for a new premixed configuration of CoSeal, a fully synthetic vascular sealant. (Product Pipeline).(Brief Article)
March 1, 2003... * Angiotech Pharmaceuticals (Vancouver, British Columbia) said it received FDA approval for a new premixed configuration of CoSeal, a fully synthetic vascular sealant. The new premixed CoSeal extends the useable lifespan after mixing to two...

Armus (Burlingame, California) launched a personal data assistant (PDA)-based preoperative cardiovascular risk calculator at the Society of Thoracic Surgeons (STS) annual meeting in San Diego, California. (Product Pipeline).(Brief Article)
March 1, 2003... * Armus (Burlingame, California) launched a personal data assistant (PDA)-based preoperative cardiovascular risk calculator at the Society of Thoracic Surgeons (STS) annual meeting in San Diego, California. The company said the Armus Risk...

Bayer Diagnostics (Tarrytown, New York) reported the availability of Advia Centaur BNP (B-type natriuretic peptide) assay, a fully automated test for use in the diagnosis of heart failure (HF), on its automated immunoassay platform, the Advia Centaur Immunoassay System. (Product Pipeline).(Bayer Diagnostics Div.)(Brief Article)
March 1, 2003... * Bayer Diagnostics (Tarrytown, New York) reported the availability of Advia Centaur BNP (B-type natriuretic peptide) assay, a fully automated test for use in the diagnosis of heart failure (HF), on its automated immunoassay platform, the Advia...

Beyond Genomics (BG; Waltham, Massachusetts) has entered into an agreement with Novartis Pharma (Basel, Switzerland) under which BG will use its Systems Biology approach to analyze samples of patients with cardiovascular disease. (Product Pipeline).(Brief Article)
March 1, 2003... * Beyond Genomics (BG; Waltham, Massachusetts) has entered into an agreement with Novartis Pharma (Basel, Switzerland) under which BG will use its Systems Biology approach to analyze samples of patients with cardiovascular disease. Under the...

Boston Scientific (BSX; Natick, Massachusetts) has initiated the launch of its Taxus paclitaxel-eluting stent system in Europe and other international markets. (Product Pipeline).(Boston Scientific Corp.)
March 1, 2003... * Boston Scientific (BSX; Natick, Massachusetts) has initiated the launch of its Taxus paclitaxel-eluting stent system in Europe and other international markets. BSX expects to launch the product in the U.S. later this year. Boston Scientific...

Cardiac Science. (Product Pipeline).(Cardiac Science Inc. presents data on safety of cardiac rhythm device)(Brief Article)
March 1, 2003... * Cardiac Science (Irvine, California) said that data from a new multicenter study demonstrates that the company's in-hospital Powerheart Cardiac Rhythm Module (CRM) is not only safe and effective, but significantly shortens hospital response...

Cardima. (Product Pipeline).(Cardima Inc.)(enhancement of surgical ablation system)
March 1, 2003... * Cardima (Fremont, California) has received FDA 510(k) clearance for what is essentially the first half of its two-pronged approach to treatment of atrial fibrillation (AF). The company reported receiving approval of its system to create scars...

Compumedics. (Product Pipeline).(sleep-cardiology system approved for marketing)(Brief Article)
March 1, 2003... * Compumedics (Fridley, Minnesota) said the FDA has granted approval to market the company's portable Somte sleep-cardiology recording system in the U.S. The potential market for Somte in the U.S. is estimated to be of the order of $130 million...

CryoLife (Kennesaw, Georgia) said a 21-patient study reported at the Society of Thoracic Surgeons annual meeting last month indicated that CryoLife's BioGlue surgical adhesive may eliminate the need for additional surgery to correct bleeding in patients implanted with ventricular heart-assist devices. (Product Pipeline).(CryoLife Inc.)(Brief Article)
March 1, 2003... * CryoLife (Kennesaw, Georgia) said a 21-patient study reported at the Society of Thoracic Surgeons annual meeting last month indicated that CryoLife's BioGlue surgical adhesive may eliminate the need for additional surgery to correct bleeding...

Daxor (New York) said two new studies conducted at Columbia Presbyterian Medical Center (also New York) were published in the journal Circulation. (Product Pipeline).(Daxor Corp.)(evaluation of blood volume measurement device)
March 1, 2003... * Daxor (New York) said two new studies conducted at Columbia Presbyterian Medical Center (also New York) were published in the journal Circulation. The first study used the Daxor BVA-100 Blood Volume Analyzer to measure the degree of blood...

Eli Lilly and Co. (Indianapolis, Indiana) said the results of the AbESTT (Abciximab in emergent stroke treatment trial), a study in patients with ischemic stroke, were announced at last month's American Heart Association-sponsored International Stroke Conference in Phoenix, Arizona. (Product Pipeline).(recovery time increased and mortality reduced)(Brief Article)
March 1, 2003... * Eli Lilly and Co. (Indianapolis, Indiana) said the results of the AbESTT (Abciximab in Emergent Stroke Treatment Trial), a study in patients with ischemic stroke, were announced at last month's American Heart Association-sponsored...

Guidant. (Product Pipeline).(Guidant Corp. launches improved pacemaker)(Brief Article)
March 1, 2003... * Guidant (Indianapolis, Indiana), reported the U.S. availability and launch of the Insignia Entra line of pacemakers. The Entra line complements the existing Insignia family of pacemakers, which was launched worldwide in June 2002, and gives...

IDev Technologies. (Product Pipeline).(mechanical thrombectomy device approved)(Brief Article)
March 1, 2003... * IDev Technologies (Houston, Texas) said it has received the CE mark for its AKonya Eliminator mechanical thrombectomy device. The company also said that it has been awarded quality certification from BSI, a quality management systems...

Intuitive Surgical. (Product Pipeline).(Intuitive Surgical Inc. markets robotic surgical device)(Brief Article)
March 1, 2003... * Intuitive Surgical (Sunnyvale, California), said it is now promoting use of its robotic da Vinci Surgical System in the U.S. for performing the additional cardiac surgical procedure of totally endoscopic atrial septal defect closure. On the...

Ischemia Technologies. (Product Pipeline).(Ischemia Technologies Inc. develops heart disease diagnostic tool)(Brief Article)
March 1, 2003... * Ischemia Technologies (Denver, Colorado) is hoping that with FDA approval to market its Ischemia Modified Albumin (IMA) test in the U.S., emergency room physicians will have a fourth diagnostic tool to determine if someone who presents with...

Medtronic Physio-Control (Redmond, Washington) reported FDA clearance and commercial market release of its infant/child electrodes for use with automated external defibrillators (AEDs) for children younger than 8 years old. (Product Pipeline).(Brief Article)
March 1, 2003... * Medtronic Physio-Control (Redmond, Washington) reported FDA clearance and commercial market release of its infant/child electrodes for use with automated external defibrillators (AEDs) for children younger than 8 years old. In addition, a new...

OmniSonics Medical Technologies. (Product Pipeline).(OmniSonics Medical Technologies Inc. gets patent on ultrasonic device)(Brief Article)
March 1, 2003... * OmniSonics Medical Technologies (Wilmington, Massachusetts) reported the issuance of U.S. patent No. 6,524,251, titled "Ultrasonic Device For Tissue Ablation and Sheath For Use Therewith." The patent has device claims and method of use claims...

Orbus Medical Technologies (Fort Lauderdale, Florida) said that Michael Kutryk, MD, PhD, an interventional cardiologist at St. Michael's Hospital (Toronto, Ontario), presented his group's latest results on circulating endothelial progenitor cell (EPC) capture technology for improved blood compatibility and biocompatibility of cardiology stents......
March 1, 2003... Orbus Medical Technologies (Fort Lauderdale, Florida) said that Michael Kutryk, MD, PhD, an interventional cardiologist at St. Michael's Hospital (Toronto, Ontario), presented his group's latest results on circulating endothelial progenitor...

St. Jude Medical (St. Paul, Minnesota) reported receiving the CE mark for its new Riata single-coil defibrillation lead. (Product Pipeline).(St. Jude Medical Inc.)(Brief Article)
March 1, 2003... * St. Jude Medical (St. Paul, Minnesota) reported receiving the CE mark for its new Riata single-coil defibrillation lead. Initially released in 2002, the Riata defibrillation lead was previously available in only a dual-coil model. The Riata...

Synthetic Blood International. (Product Pipeline).(Synthetic Blood International Inc. )(development and evaluation of a blood substitute)(Brief Article)
March 1, 2003... * Synthetic Blood International (SYBD; Costa Mesa, California) said that the company submitted an investigational new drug application (IND) to the FDA in early February for Oxycyte, its perfluorocarbon-based blood substitute and therapeutic...

World heart. (Product Pipeline).(World Heart Corp. introduces new heart assist device)(Brief Article)
March 1, 2003... * World Heart (Ottawa, Ontario) unveiled the newest configuration of its not-yet-approved HeartSaverVAD (ventricular assist device) last month to the media and analysts at the Toronto Stock Exchange, saying that it believes the new system will...