Cardiovascular Device Update articles from July 2004

Cardiovascular Device Update archives from July 2004

Continued slow adoption of drug-eluting stents in Europe.(EuroPCR meeting)
July 1, 2004... PARIS -- Although drug-eluting stents were launched in Europe about a year prior to their introduction in the U.S., the market penetration of the devices in Europe is now significantly less than in the U.S. As discussed at the EuroPCR meeting...

Conor Medsystems cites stent data from pilot study.(EuroPCR notebook)
July 1, 2004... Conor Medsystems (Menlo Park, California) presented acute and follow-up data from the PISCES (Paclitaxel In-Stent Controlled Elution Study) trial during last month's EuroPCR (previously Paris Course on Revascularization) conference in Paris....

Abbott sees 'new era' in vascular closure.(EuroPCR notebook)
July 1, 2004... Abbott Vascular Devices (Redwood City, California), a division of Abbott Laboratories (Abbott Park, Illinois), unveiled the StarClose Vascular Closure System. The company said the introduction marks the world's first circumferential clip-based...

Study backs Cypher's value for diabetics.(EuroPCR notebook)
July 1, 2004... Data presented at the EuroPCR meeting provided further clinical evidence that use of the Cypher sirolimus-eluting coronary stent, made by the Cordis (Miami Lakes, Florida) unit of Johnson & Johnson (New Brunswick, New Jersey), is an effective...

Mentice (Gothenburg, Sweden/San Diego, California), together with Guidant (Indianapolis, Indiana), reported that for the first time during a live-case transmission at EuroPCR, a carotid stenting procedure was rehearsed on a virtual reality simulator before the procedure was performed on the patient.(Brief Article)
July 1, 2004... * Mentice (Gothenburg, Sweden/San Diego, California), together with Guidant (Indianapolis, Indiana), reported that for the first time during a live-case transmission at EuroPCR, a carotid stenting procedure was rehearsed on a virtual reality...

Guidant.(Brief Article)
July 1, 2004... * Guidant reported CE mark approval and launch of the Multi-Link Mini Vision Coronary Stent System, the company's first cobalt chromium stent for treating coronary artery disease in small vessels, and CE mark approval and launch of the...

Medtronic, Genzyme form j-v for cardio disease therapies.
July 1, 2004... In an agreement that appears to bolster the growing trend toward medical device/biotechnology combination products, device giant Medtronic (Minneapolis, Minnesota) and Genzyme (Cambridge, Massachusetts), a large biotech company that focuses on...

Zargis Medical's Cardioscan is new approach on murmurs.
July 1, 2004... Listening to the heart with a stethoscope is the most widely used method for the detection of heart murmurs, but Zargis Medical (Princeton, New Jersey) has developed an auscultatory device it hopes will become the new standard of care. The...

Lab Tests Online is replicated for UK use.(Report from Europe)(www.labtestsonline.org.uk)
July 1, 2004... The American Association for Clinical Chemistry (AACC; Washington), publisher of Lab Tests Online, a web site for laboratory testing information, has launched a second version of the site in the United Kingdom. The new version of Lab Tests...

Trial cites benefits of Diovan.(Report from Europe)
July 1, 2004... Novartis (Basel, Switzerland) reported at last month's European Meeting on Hypertension the results of the Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial, a randomized, active-controlled study conducted at 934 clinical sites...

Escalon Medical (Wayne, Pennsylvania) said it revised its initial exchange offer for the shares of Drew Scientific Group (London), a company specializing in analytical systems for laboratory testing worldwide.(Acquisitions)(Brief Article)
July 1, 2004... * Escalon Medical (Wayne, Pennsylvania) said it revised its initial exchange offer for the shares of Drew Scientific Group (London), a company specializing in analytical systems for laboratory testing worldwide. Escalon's revised offering is to...

SurModics (Eden Prairie, Minnesota), a provider of surface modification and drug delivery solutions to the medical device industry, said it has obtained an option to acquire an exclusive license from OctoPlus (Leiden, the Netherlands) to two novel classes of biodegradable polymers for use in the site specific delivery of drugs from medical devices.(Acquisitions)(Brief Article)
July 1, 2004... * SurModics (Eden Prairie, Minnesota), a provider of surface modification and drug delivery solutions to the medical device industry, said it has obtained an option to acquire an exclusive license from OctoPlus (Leiden, the Netherlands) to two...

Panel opposes broader WorldHeart labeling.(Business Developments)
July 1, 2004... In a nearly unanimous vote, an FDA panel voted last month to oppose new labeling sought by WorldHeart (Ottawa, Ontario) for its Novacor LVAS (left ventricular assist system) for use with very sick heart-failure patients. The panel said...

Defibtech gains a niche in AED market.(Business Developments)(automatic external defibrillator)
July 1, 2004... When one looks at the competition that automatic external defibrillator (AED) maker Defibtech (Guilford, Connecticut) faces, it's a wonder how it manages to survive, and not only that, but thrive in a market that would appear at first blush to...

Biopure has new CEO, cardio focus.(Business Developments)(Chief executive officer)
July 1, 2004... Biopure (Cambridge, Massachusetts) last month reported sweeping organizational and strategic changes, including the naming of a new president and chief executive officer, restructuring of the company's management team, realignment of corporate...

Angiotech continues its ortho push.(Business Developments)(Brief Article)
July 1, 2004... Angiotech Pharmaceuticals (Vancouver, British Columbia), a company best known for making coatings for coronary stents and other medical devices, continued its more recent push into the orthopedics and spinal surgery market with a pair of...

Cardiocom (Minneapolis, Minnesota) reported that Ucare Minnesota, a non-profit health maintenance organization, renewed its multi-year agreement with the disease management company to provide systems for remote daily home monitoring of Ucare's congestive heart failure (CHF) patients.(Agreements)(Brief Article)
July 1, 2004... * Cardiocom (Minneapolis, Minnesota) reported that Ucare Minnesota, a non-profit health maintenance organization, renewed its multi-year agreement with the disease management company to provide systems for remote daily home monitoring of...

Forest Laboratories (New York) and Paion (Aachen, Germany) have entered into an agreement for development and marketing of Paion's desmoteplase product in the U.S. and Canada.(Agreements)
July 1, 2004... * Forest Laboratories (New York) and Paion (Aachen, Germany) have entered into an agreement for development and marketing of Paion's desmoteplase product in the U.S. and Canada. Desmoteplase, a plasminogen activator, or blood clot-dissolving...

Legislation targets screening for AAA.(Abdominal Aortic Aneurysm)
July 1, 2004... A bipartisan group of lawmakers introduced legislation last month to change Medicare to cover ultrasound screening for abdominal aortic aneurysm (AAA), often called a "silent killer." At a Capitol Hill press conference, Sens. Christopher Dodd...

Better evidence seen as reimbursement key.(Market Updates)
July 1, 2004... Say the word "location" three times fast and you've got the basic mantra for how to pick prime real estate. The parallel mantra for the Center for Medicare & Medicaid Services (CMS; Baltimore, Maryland), as well as the FDA, would seem to be...

Task force warns against funding cuts.(Market Updates)
July 1, 2004... A task force led by the Alliance for Aging Research (Washington) held a meeting on Capitol Hill last month to release its report highlighting developments in medical research and new technology and the need for increased funding for the...

Parents' AF increases risk for offspring.(Market Updates)(atrial fibrillation )
July 1, 2004... Having a parent with atrial fibrillation (AF) appears to strongly increase an offspring's risk of also developing this disorder, according to a new study of participants in the National Heart, Lung, and Blood Institute's (NHLBI; Bethesda,...

Angeion (St. Paul, Minnesota) said Richard Jahnke, president and chief executive officer of Angeion and its Medical Graphics subsidiary, plans to retire at the end of the fiscal year on Oct. 31.(Personnel File)(Brief Article)
July 1, 2004... * Angeion (St. Paul, Minnesota) said Richard Jahnke, president and chief executive officer of Angeion and its Medical Graphics subsidiary, plans to retire at the end of the fiscal year on Oct. 31. Jahnke became CEO of Medical Graphics in August...

Edwards Europe.(Personnel File)(Edwards Lifesciences)(Brief Article)
July 1, 2004... * Patrick Vergnet has been named president of Edwards Lifesciences' (Irvine, California) Edwards Europe unit. Verguet most recently served as Edwards' vice president of sales and country management of heart valve, cardiac surgery systems, and...

Enpath Medical (Plymouth, Minnesota) said Vincent Owens, currently president of the company's Lead Technologies Division (formerly Biomec Cardiovascular), would leave the company, effective at the end of June, to become president and chief executive officer of Texcel (East Longmeadow, Massachusetts).(Personnel File)(Brief Article)
July 1, 2004... * Enpath Medical (Plymouth, Minnesota) said Vincent Owens, currently president of the company's Lead Technologies Division (formerly Biomec Cardiovascular), would leave the company, effective at the end of June, to become president and chief...

OmniSonics Medical Technologies.(Personnel File)(Brief Article)
July 1, 2004... * Richard Ganz has been named president and chief executive officer of OmniSonics Medical Technologies (Wilmington, Massachusetts). Ganz most recently was president of Baxter Healthcare's North American renal business and prior to that held...

Celera reports on 2 genes linked to MI.(Product Pipeline)(myocardial infarction)(Brief Article)
July 1, 2004... As part of its ongoing association studies in several cardiovascular indications, Celera Diagnostics (Alameda, California) has presented data linking genetic variations in two genes with increased risk for myocardial infarction (MI), commonly...

Advanced Magnetics.(Product Pipelinecurrently in Phase II clinical trials for use as a contrast agent in MRA.)(Brief Article)
July 1, 2004... * Advanced Magnetics (Cambridge, Massachusetts) reported the presentation of data on ferumoxytol, the company's investigational magnetic resonance angiography (MRA) contrast agent, at the American Society of Neuroradiology meeting in Seattle,...

Akers Biosciences.(Product Pipeline)(Brief Article)
July 1, 2004... * Akers Biosciences (Thorofare, New Jersey) said it has received FDA clearance for its rapid test for Heparin/Platelet Factor-4 (HPF-4) antibodies. The HealthTEST HPF4 Antibody Assay is designed to identify patients at risk for developing...

Angiotech Pharmaceuticals.(Product Pipeline)(Brief Article)
July 1, 2004... * Angiotech Pharmaceuticals (Vancouver, British Columbia) has completed enrollment in its vascular wrap study, nearly six months earlier than anticipated. The company began enrollment in the trial last October. Patients suffering from poor...

Bayer HealthCare Diagnostics.(Product Pipeline)(Brief Article)
July 1, 2004... * Bayer HealthCare Diagnostics (Tarrytown, New York) said its BNP (B-type natriuretic peptide) test for cardiac patients has received FDA approval for two additional claims: the prediction of survival in patients after myocardial infarction in...

Biophan Technologies.(Product Pipeline)(Brief Article)
July 1, 2004... * Biophan Technologies (Rochester, New York) reported details of a study on pacemaker safety released at the Heart Rhythm Society annual meeting in San Francisco, California, in May. The study indicated that a standard pacemaker lead, attached...

Cambridge Heart.(Product Pipeline)(patent for analytical signal method for analysis of T-wave alternans)(Brief Article)
July 1, 2004... * Cambridge Heart (Bedford, Massachusetts) reported the receipt of patent No. 6,735,466 from the U.S. Patent and Trademark Office, titled "Analytical signal method for analysis of T-wave alternans." The company also received a notice of...

CardioGenesis.(Product Pipeline)(Brief Article)
July 1, 2004... * CardioGenesis (Foothills Ranch, California) reported that a team of physicians who have performed and developed a variety of approaches to transmyocardial revascularization (TMR) concluded in an article featured in the June edition of The...

Cholestech.(Product Pipeline)(Brief Article)
July 1, 2004... * Cholestech (Hayward, California) reported FDA clearance of its High Sensitivity C-Reactive Protein (hs-CRP) test. The American Heart Association and the Centers for Disease Control and Prevention recommend that in individuals determined to be...

Cook.(Product Pipeline)(Brief Article)
July 1, 2004... * The FDA has cleared Cook's (Bloomington, Indiana) next-generation Zenith Flex AAA Endovascular Graft for U.S. distribution. The company also released two-year data on the original Zenith abdominal aortic aneurysm (AAA) device, which was...

Digirad.(Product Pipeline)(Cardius-1M system)(Brief Article)
July 1, 2004... * Digirad (San Diego, California) reported the introduction of its Cardius-1M system, which it said represents a significant advance in nuclear cardiac imaging by offering physicians greater flexibility through an upgradeable mobile platform...

LuMend.(Product Pipeline)(Frontrunner XP Chronic Total Occlusions )(Brief Article)
July 1, 2004... * LuMend (Redwood City, California) said it is launching the Frontrunner XP Chronic Total Occlusions (CTO) Catheter platform as part of its new peripheral vascular strategic initiatives. The XP family of catheters is based on the Frontrunner...

Medtronic.(Product Pipeline)(InSync cardiac resynchronization therapy system )(Brief Article)
July 1, 2004... * Medtronic (Minneapolis, Minnesota) reported that it has launched the InSync cardiac resynchronization therapy system in Japan, bringing a new therapy for people suffering from heart failure to another major global market. InSync is an...

Possis Medical.(Product Pipeline)(AngioJet Xpeedior 120)(AngioJet Power Pulse Spray Ancillary Kit )(Brief Article)
July 1, 2004... * Possis Medical (Minneapolis, Minnesota) reported that it has received two marketing clearances from the FDA. The AngioJet Xpeedior 120 catheter and the AngioJet Power Pulse Spray Ancillary Kit have been cleared for the infusion of...

QRS Diagnostic.(Product Pipeline)(Brief Article)
July 1, 2004... * QRS Diagnostic (Plymouth, Minnesota) reported that the U.S. Patent and Trademark Office approved a new patent on its design of medical devices contained in computer cards. U.S. patent No. 6,712,762 is a continuation of patent No. 6,159,147,...

Rafael Medical Technologies.(Product Pipeline)(SafeFlo Retrievable Vena Cava Filter)(VascuGrasp Retrieval System)(Brief Article)
July 1, 2004... * Rafael Medical Technologies (Dover, Delaware) has received CE mark approval for the SafeFlo Retrievable Vena Cava Filter for the prevention of pulmonary embolism as well as for the VascuGrasp Retrieval System, a foreign body retrieval device...

Revivant.(Product Pipeline)(Brief Article)
July 1, 2004... * Revivant (Sunnyvale, California) reported that five centers are participating in the AutoPulse Assisted Prehospital International Resuscitation (ASPIRE) Trial to evaluate the safety and effectiveness of its AutoPulse Resuscitation System, an...

Spectranetics.(Product Pipeline)(Brief Article)
July 1, 2004... * Spectranetics (Colorado Springs, Colorado) said it has received conditional approval from the FDA to begin the Extended FAMILI clinical trial, which will study the use of the company's excimer laser catheters to treat heart attack patients....

St. Jude Medical.(Product Pipeline)(Brief Article)
July 1, 2004... * St. Jude Medical (St. Paul, Minnesota) said the FDA has approved a premarket approval supplement creating new labeling for the Angio-Seal vascular closure device. The new labeling allows clinicians to re-stick 1 cm proximal to the same...

Toshiba America Medical Systems.(Product Pipeline)(Brief Article)
July 1, 2004... * Toshiba America Medical Systems (Tustin, California) reported that it has received FDA marketing clearance for its C-panel flat-panel detector (FPD). Designed specifically for cardiac imaging, C-panel FPD technology delivers high-resolution...

Trimedyne.(Product Pipeline)(Brief Article)
July 1, 2004... * Trimedyne (Irvine, California) reported the issuance of U.S. patent No. 6,740,107, which covers new, minimally invasive laser devices designed to treat mitral valve regurgitation. Trimedyne's patent covers designs for two new laser devices to...

Vasamed.(Product Pipeline)(Brief Article)
July 1, 2004... * Vasamed (Minneapolis, Minnesota) reported that the U.S. Patent and Trademark Office granted it a method patent for a new pulse oximeter that incorporates signals from a laser Doppler velocimeter (LDV) and an impedance cardiograph (ICG) to...

Ventracor.(Product Pipeline)(Brief Article)
July 1, 2004... * Ventracor (Sydney, Australia) said several hospital ethics committees in Australia and New Zealand are currently reviewing the final protocols for the CE mark trial of its VentrAssist implantable left ventricular assist system, with...

Zoll Medical.(Product Pipeline)(Brief Article)
July 1, 2004... * Zoll Medical (Chelmsford, Massachusetts) said the FDA has granted marketing clearance for the new pediatric capability in its automated external defibrillator, the AED Plus. This capability, for children up to 8 years of age, is now available...