Cardiovascular Device Update articles from May 2003

Cardiovascular Device Update archives from May 2003

Growing demand, expanding applications in cardio devices.
May 1, 2003... CHICAGO, Illinois--The U.S. introduction of drug-eluting stents, made possible by the FDA's late-April approval of the Cypher stent from Johnson & Johnson's (New Brunswick, New Jersey) Cordis (Miami Lakes, Florida) unit (see story, page 8),...

Cordis is first to get U.S. approval for its drug-eluting stent.
May 1, 2003... As expected, the Cypher drug-eluting coronary stent from Johnson & Johnson (New Brunswick, New Jersey) subsidiary Cordis (Miami Lakes, Florida) is the first to market in the U.S. after receiving FDA approval late last month. While Cordis was...

Aorta is the soft spot in Marfan pathology. (From the Lab).
May 1, 2003... The congenital Marfan syndrome afflicts some 200,000 people in the U.S. Worldwide, the incidence is one in 10,000, or about 700,000 of the planet's population. That syndrome, said molecular geneticist Francisco Ramirez, chief scientific officer...

Study encouraging for ischemia treatment. (Report from Europe).
May 1, 2003... A short exposure to a specific combination of two growth factors may be all it takes to stimulate the growth of new blood vessels that persist indefinitely, a new study suggests. Yihai Cao, professor of vascular biology at the Laboratory of...

Charles River showcases Irish facilities. (Report from Europe).(Brief Article)
May 1, 2003... Research tools and services provider Charles River Laboratories (Wilmington, Massachusetts) showcased its new surgical suite/cardiac catheterization lab in County Mayo, Ireland, in early May by hosting a medical device symposium featuring...

MediGene spins off cardio unit. (Report from Europe).(Brief Article)
May 1, 2003... MediGene AG (Martinsried, Germany) completed the spin-off of its cardiology and metabolic disease unit by working together with the investment company BioM AG (Munich, Germany) to establish a new firm, Larnax GmbH. MediGene will hold almost 25%...

CryoCath Technologies (Montreal, Quebec), a developer of cryotherapy products to treat cardiovascular disease, reached an agreement with Endocare (Irvine, California) to acquire the exclusive and permanent global rights to SurgiFrost, a surgical probe system to ablate cardiac arrhythmias. (Acquisitions).(Brief Article)
May 1, 2003... * CryoCath Technologies (Montreal, Quebec), a developer of cryotherapy products to treat cardiovascular disease, reached an agreement with Endocare (Irvine, California) to acquire the exclusive and permanent global rights to SurgiFrost, a...

Guidant (Indianapolis, Indiana) reported that it has acquired a majority interest in an early-stage company focused on developing fully biosabsorbable vascular stent platforms. (Acquisitions).(Brief Article)
May 1, 2003... * Guidant (Indianapolis, Indiana) reported that it has acquired a majority interest in an early-stage company focused on developing fully biosabsorbable vascular stent platforms. Guidant acquired the venture from SyneCor (Research Triangle...

Spectranetics (Colorado Springs, Colorado) said it has acquired the assets of privately held LaTIS, a Minnesota-based developer of technology that is used to treat ischemic stroke. (Aquisitions).(Brief Article)
May 1, 2003... * Spectranetics (Colorado Springs, Colorado) said it has acquired the assets of privately held LaTIS, a Minnesota-based developer of technology that is used to treat ischemic stroke. Terms of the acquisition include a $100,000 purchase price...

St. Jude Medical (St. Paul, Minnesota) completed its acquisition of Getz Bros. Co. (Tokyo), the largest distributor of St. Jude's products in Japan. (Acquisitions).(Brief Article)
May 1, 2003... * St. Jude Medical (St. Paul, Minnesota) completed its acquisition of Getz Bros. Co. (Tokyo), the largest distributor of St. Jude's products in Japan. The company announced the planned deal last September. St. Jude Medical paid about $230...

Patient monitoring firm Welch Allyn (Skaneateles Falls, New York) and MRL (Medical Research Laboratories; Buffalo Grove, Illinois), a manufacturer of therapeutic and monitoring cardiovascular devices, said that they have concluded a merger in which Welch Allyn has acquired all outstanding shares of MRL stock. (Acquisitions).(Brief Article)
May 1, 2003... * Patient monitoring firm Welch Allyn (Skaneateles Falls, New York) and MRL (Medical Research Laboratories; Buffalo Grove, Illinois), a manufacturer of therapeutic and monitoring cardiovascular devices, said that they have concluded a merger in...

20-year data reported on tissue heart valve. (Business Developments).
May 1, 2003... Edwards Lifesciences (Irvine, California) reported completion early this month of a 20-year follow-up on the effectiveness and durability of its leading aortic pericardial tissue heart valve. The data indicate that patients 60 years and older...

FDA clears new Pall blood filtration system. (Business Developments).
May 1, 2003... Pall (East Hills, New York) has received FDA clearance to market its new Leukotrap WB Filtration System, thus adding another component to the company's growing arsenal of blood filtration technology. The system incorporates Pail's Sterile Air...

8th AbioCor trial patient dies. (Business Developments).(Brief Article)
May 1, 2003... Jewish Hospital (Louisville, Kentucky) reported the death last month of the eighth person implanted in the trial of the AbioCor total replacement heart made by Abiomed (Danvers, Massachusetts). The patient was identified as Keith Blakeley, of...

Pacemaker charity victim of own growth. (Business Developments).(Brief Article)
May 1, 2003... A charity that matches donated pacemakers with patients who otherwise could not afford one is the latest of many organizations struggling in the current economy. Heartbeat International (Tampa, Florida) is struggling to cover its administrative...

Cardiac Science (Irvine, California), a manufacturer of public access defibrillators, said it is now working in conjunction with the American Red Cross (Washington) national organization and local Red Cross chapters across the country to make Powerheart automated external defibrillators (AEDs) available to businesses, government facilities and individuals in their communities. (Agreements).(Brief Article)
May 1, 2003... * Cardiac Science (Irvine, California), a manufacturer of public access defibrillators, said it is now working in conjunction with the American Red Cross (Washington) national organization and local Red Cross chapters across the country to make...

EP Medsystems (West Berlin, New Jersey), a manufacturer of cardiac electrophysiology products used to diagnose and treat certain cardiac rhythm disorders, reported the addition of the alert systems for internal cardioversion to the portfolio of products under contract for Premier (San Diego, California) members. (Agreements).(Brief Article)
May 1, 2003... * EP Medsystems (West Berlin, New Jersey), a manufacturer of cardiac electrophysiology products used to diagnose and treat certain cardiac rhythm disorders, reported the addition of the Alert Systems for internal cardioversion to the portfolio...

eResearchTechnology (eRT; Philadelphia, Pennsylvania), a provider of centralized electrocardiographic (ECG) collection and interpretation services, said it has received an agreement for more than $825,000 in cardiac safety monitoring and services from an unnamed top 10 pharmaceutical company for one of its drug candidates in late-phase clinical development. (Agreements).(Brief Article)
May 1, 2003... * eResearchTechnology (eRT; Philadelphia, Pennsylvania), a provider of centralized electrocardiographic (ECG) collection and interpretation services, said it has received an agreement for more than $825,000 in cardiac safety monitoring and...

Guidant (Indianapolis, Indiana) and ResMed (Poway, California) said they would work together to develop products that diagnose and treat sleep-disordered breathing and cardiac rhythm disorders. (Agreements).(Brief Article)
May 1, 2003... * Guidant (Indianapolis, Indiana) and ResMed (Poway, California) said they would work together to develop products that diagnose and treat sleep-disordered breathing and cardiac rhythm disorders. The agreement calls for the companies to...

Joint Purchasing Corp. (JPC; New York) said it has entered into a three-year sole-source agreement with Medrad (Pittsburgh, Pennsylvania), a provider of vascular injection systems, magnetic resonance (MR) accessories and services that enable and enhance imaging procedures of the human body. (Agreements).(Brief Article)
May 1, 2003... * Joint Purchasing Corp. (JPC; New York) said it has entered into a three-year sole-source agreement with Medrad (Pittsburgh, Pennsylvania), a provider of vascular injection systems, magnetic resonance (MR) accessories and services that enable...

Zealand Pharma A/S (Glostrup, Denmark) has entered into a development and license agreement with Wyeth (Madison, New Jersey). (Agreements).(Brief Article)
May 1, 2003... * Zealand Pharma A/S (Glostrup, Denmark) has entered into a development and license agreement with Wyeth (Madison, New Jersey). The two companies will co-develop ZP123, Zealand's drug candidate for the treatment of arrhythmias and other...

Increased awareness is PAD 'call to action'. (Market Updates).
May 1, 2003... A call to action to increase the awareness, detection and treatment of peripheral arterial disease (PAD) among healthcare professionals was published last month in the Archives of Internal Medicine by the Prevention of Atherothrombotic Disease...

Even pictures don't alter risky behavior. (Market Updates).
May 1, 2003... A picture is supposed to be worth a thousand words, but even a vivid picture of clogged blood vessels isn't enough to force large changes in behavior that risks heart health, according to a report in the May 7 issue of the Journal of the...

Med-tech push right up Medical Alley. (Market Updates).
May 1, 2003... Medical Alley (St. Louis Park, Minnesota), a trade association that promotes Minnesota's healthcare industry, is enjoying a major growth spurt even as the industry on which it is centered, like most others, battles economic uncertainty. Don...

Lipid Sciences. (Personnel File).(Brief Article)
May 1, 2003... * S. Lewis Meyer, PhD, has been named president and CEO of Lipid Sciences (Pleasanton, California). He will continue to serve as a director, a position he has held since July 2002. Meyer was president and CEO of Imatron until its acquisition by...

Recom Managed Systems. (Personnel File).(Brief Article)
May 1, 2003... * Charles McGill has been appointed chief financial officer of Recom Managed Systems (Los Angeles, California). McGill previously worked at Teledyne, Allegheny Teledyne and Teledyne Technologies. Recom Managed Systems describes itself as an...

Rubicon Medical. (Personnel File).(Brief Article)
May 1, 2003... * Phillip Carter has been named vice president of sales and marketing for Rubicon Medical (Salt Lake City, Utah). Carter previously served as director of global marketing at Precision Vascular. Rubicon is focused on the production and...

CryoCath's Freezor approval not glacial. (Product Pipeline).
May 1, 2003... The traditionally deliberative FDA apparently thinks a cryotherapy system developed by CryoCath Technologies (Kirkland, Quebec), which uses extremely cold temperatures to treat diseased tissue, is a hot commodity, granting the product an...

Advanced Stent Technologies. (Product Pipeline).(Brief Article)
May 1, 2003... * Advanced Stent Technologies (AST; Pleasanton, California) received FDA approval to begin a pivotal study of its SLK-View stent and delivery system. The study, named Bifurcation Optimized with the SLK-View Stent (BOSS), will use the SLK-View...

Bioheart. (Product Pipeline).
May 1, 2003... * Bioheart (Weston, Florida) said that physicians at Mount Sinai Medical Center (New York) last month conducted the first procedure in the U.S. in which cells taken from a patient's leg were implanted in the patient's heart to treat congestive...

Bristol-Myers Squibb Medical Imaging. (Product Pipeline).(Brief Article)
May 1, 2003... * Bristol-Myers Squibb Medical Imaging (Billerica, Massachusetts) said the results of a company-sponsored study demonstrate that regardless of race, patients with a normal stress test with Cardiolite (Kit for the Preparation of Technetium Tc99m...

CardioMend. (Product Pipeline).(Brief Article)
May 1, 2003... * CardioMend (Santa Barbara, California) reported the first clinical use of its product, AccuMend SL, a set of instruments designed to facilitate stentless aortic valve reconstruction using autologous pericardium. Gilles Dreyfus, MD, cardiac...

CardioVations. (Product Pipeline).(Brief Article)
May 1, 2003... * CardioVations (Somerville, New Jersey), a division of Ethicon, introduced the Myolift Heart Retractor and the Flexsite Heart Stabilizer, instruments that help position the heart and stabilize the coronary artery during cardiac surgery. The...

Cybernet Medical. (Product Pipeline).(Brief Article)
May 1, 2003... * Cybernet Medical (Ann Arbor, Michigan) said it has received FDA clearance to expand the capabilities of its MedStar Disease Management Data Collection System. Used to remotely collect and transmit the physiological data of patients with...

Dade Behring. (Product Pipeline).(Brief Article)
May 1, 2003... * Dade Behring (Deerfield, Illinois) received FDA clearance to make its D-dimer test available on its Stratus CS instrument, for use in STAT and central laboratories and in acute-care settings. An elevated D-dimer result reflects increased...

Epix Medical. (Product Pipeline).(Brief Article)
May 1, 2003... * Epix Medical (Cambridge, Massachusetts) reported the selection of a compound, EP-2104R, to move toward clinical development. EP-2104R is an imaging agent specifically designed to enable detection of thrombus, or blood clots, in humans using...

EPMedSystems. (Product Pipeline).(Brief Article)
May 1, 2003... * EPMedSystems (West Berlin, New Jersey) said that it has submitted its ViewMate intracardiac ultrasound catheter system 510(k) filing to the FDA for regulatory approval. This is the company's second step in the process of the globalization of...

Guidant. (Product Pipeline).(Brief Article)
May 1, 2003... * Guidant (Indianapolis, Indiana) reported FDA approval of its next-generation implantable defibrillator, the Vitality AVT implantable cardioverter defibrillator (ICD) system. The new technology combines complete ventricular and atrial...

International Technidyne. (Product Pipeline).(Brief Article)
May 1, 2003... * International Technidyne (ITC; Edison, New Jersey), a division of Thoratec (Pleasanton, California), has introduced the Hgb Pro Professional Hemoglobin Testing System for fast total hemoglobin testing in physicians' offices. The new system...

Medtronic. (Product Pipeline).
May 1, 2003... * Medtronic (Minneapolis, Minnesota) last month reported the first U.S. implant of the InSync III Marquis implantable cardioverter-defibrillator (ICD) system and the start of a new clinical trial of the company's newest-generation cardiac...

Orqis Medical. (Product Pipeline).(Brief Article)
May 1, 2003... * Orqis Medical (Lake Forest, California) received an investigational device exemption (IDE) from the FDA last month to perform feasibility trials of its Cancion family of minimally invasive Cardiac Recovery Systems (CRS) for use in treating...

PharmaNetics. (Product Pipeline).(Brief Article)
May 1, 2003... * PharmaNetics (Raleigh, North Carolina) filed a 510(k) submission with the FDA for its Thrombin Inhibitor Management Test for the rapid management of Angiomax, an anticoagulant developed by The Medicines Company (Parsippany, New Jersey). This...

Quinton Cardiology Systems. (Product Pipeline).(Brief Article)
May 1, 2003... * Quinton Cardiology Systems (Bothell, Washington) has started shipping the new Atria 3000 ECG under the Burdick brand name. The compact system is designed primarily for use in physicians' practices. This new electrocardiograph is the first in...

Respironics. (Product Pipeline).(Brief Article)
May 1, 2003... * Respironics (Murraysville, Pennsylvania) reported results from a randomized clinical trial of patients with heart failure conducted at Toronto General Hospital, University Health Network, Mount Sinai Hospital and the Toronto Rehabilitation...

St. Jude Medical. (Product Pipeline).(Brief Article)
May 1, 2003... * St. Jude Medical (St. Paul, Minnesota) said it has received FDA approval to release the Identity ADx DR and Identity ADx XL DR pacemakers, with launch planned for this month. Dr. Derek Rodrigues, MD, performed the first Identity ADx pacemaker...

Synthetic Blood International. (Product Pipeline).(Brief Article)
May 1, 2003... * Synthetic Blood International (SYBD; Costa Mesa, California) said the FDA has requested minor revisions to the Phase I clinical study protocol in the investigational new drug application (IND) that SYBD submitted for Oxycyte in February. The...

Thoratec. (Product Pipeline).
May 1, 2003... * The FDA last month approved Thoratec's (Pleasanton, California) premarket approval supplement (PMA-S) allowing the use of its HeartMate XVE left ventricular assist device (LVAD) for destination therapy. That device would immediately supplant...

Velocimed. (Product Pipeline).(Brief Article)
May 1, 2003... * Velocimed (Minneapolis, Minnesota) said it has received the CE mark for the Proxis Embolic Protection System, the first proximal embolic protection device designed for coronary applications. The company said it expects to launch the product...

V.I. Technologies. (Product Pipeline).(Brief Article)
May 1, 2003... * V.I. Technologies (Watertown, Massachusetts) said it has completed the recruitment of the clinical trial study sites for the company's chronic transfusion study. These sites will be more than sufficient to enroll the 70 patients requiring...

WorldHeart. (Product Pipeline).
May 1, 2003... * WorldHeart (Ottawa, Ontario) has received a letter from the FDA regarding the agency's review of the company's destination therapy premarket approval supplement for the Novacor LVAS (left ventricular assist system). The FDA has requested...