Cardiovascular Device Update articles from December 2002

Cardiovascular Device Update archives from December 2002

Biotechnology, new devices to reshape cardio device market.
December 1, 2002... CHICAGO, Illinois -- The annual conference of the American Heart Association (AHA; Dallas, Texas), held here in mid-November, addressed a wide range of topics related to cardiovascular disease, and it often serves as a forum for presentation of...

Positive early results in FilterWire EX trial. (AHA notebook).(Brief Article)
December 1, 2002... CHICAGO, Illinois -- Boston Scientific (Natick, Massachusetts) rolled out preliminary results from its FIRE clinical trial, which studied the company's FilterWire EX Embolic Protection Device during a symposium at last month's American Heart...

Biosite. (AHA notebook).(Biosite Diagnostics Inc.)(Brief Article)
December 1, 2002... Biosite (San Diego, California) reported an enhancement to its Triage BNP Test enabling clinicians to obtain higher quantitative measurements of B-type natriuretic peptide (BNP) in heart failure patients. With an extended dynamic range of up to...

Ron Waksman, MD, associate chief of medicine at Washington Hospital Center (Washington), presented preclinical results of Miravant Medical Technologies' (Santa Barbara, California) treatment in development for atherosclerotic vulnerable plaque (VP). (AHA notebook).(Brief Article)
December 1, 2002... Ron Waksman, MD, associate chief of medicine at Washington Hospital Center (Washington), presented preclinical results of Miravant Medical Technologies' (Santa Barbara, California) treatment in development for atherosclerotic vulnerable plaque...

Royal Philips Electronics. (AHA notebook).(Brief Article)
December 1, 2002... Royal Philips Electronics (Amsterdam, the Netherlands) used the AHA meeting to banner the recent FDA clearance of its Sonos 7500 ultrasound system with Live 3D Echo, calling it "the first functional ultrasound system that enables cardiologists...

Zebrafish repair and replace injured heart. (From The Lab).
December 1, 2002... Human beings (Homo sapiens) are touted as topping the totem pole of life on earth. But we can't beat the feats of lowly newts and salamanders. When one of these critters loses a limb, a tail, a fin or other body part, it simply regenerates the...

WHO: cardio deaths, disability can be cut. (Report from Europe).(World Health Organization)
December 1, 2002... A major finding in the World Health Report 2002 from the World Health Organization (WHO; Geneva, Switzerland) is that blood pressure alone causes around 50% of cardiovascular (CV) disease worldwide. Cholesterol causes around one-third, while...

Vivolution. (New products in Europe).(Brief Article)
December 1, 2002... Vivolution (Rungsted, Denmark) has launched Europe the Vivostat system, which uses autologous fibrin sealant, derived from the patient's blood prior to surgery, thus minimizing the risk of a viral or prion infection. It is administered by means...

Graseby Medical. (New products in Europe).(Brief Article)
December 1, 2002... The MR20 pediatric monitor from Graseby Medical (Watford, UK) provides both respiration and ECG data on a hand-held monitor which is battery operated with an AC/DC power supply adaptor. The small instrument incorporates a high-capacity event...

Heine Optotechnik. (New products in Europe).(Brief Article)
December 1, 2002... Heine Optotechnik (Herrsching, Germany) has developed the Memotronic PC2 blood pressure monitor, comprised of both wrist pressure-cuff and monitor with a LCD screen. Pressing on one button inflates the wrist-cuff and provides systolic and...

Myosix, Genzyme collaborate on cell therapy.(Genzyme Biosurgery)(Brief Article)
December 1, 2002... Genzyme Biosurgery (Cambridge, Massachusetts) is collaborating with Myosix (Paris) to develop further an advanced series of clinical trials on the use of cell therapy to treat heart disease. A European multicenter Phase II trial is starting to...

EMEA warns on Refludan.(European Medicines Evaluation Agency)(allergic reaction to this anticoagulant causes death)(Brief Article)
December 1, 2002... The European Medicines Evaluation Agency (EMEA; London) has revealed the deaths of five European patients as a result of grave allergic reactions to Refludan, an anticoagulant marketed by Schering (Berlin, Germany). The sole marketing rights to...

Camtronics Medical Systems (Hartland, Wisconsin), a subsidiary of Analogic (Peabody, Massachusetts), said that it has purchased VMI Medical (Ottawa, Ontario). (Acquisitions).(Brief Article)
December 1, 2002... Camtronics Medical Systems (Hartland, Wisconsin), a subsidiary of Analogic (Peabody, Massachusetts), said that it has purchased VMI Medical (Ottawa, Ontario). Terms of the deal were not disclosed. VMI is an information software company...

CardioTech International (Woburn, Massachusetts) said it expects the acquisition of Gish Biomedical (Rancho Santa Margarita, California) to be accretive to earnings within the first year and to dramatically increase revenues. (Acquisitions).(CardioTech International Inc.)(Gish Biomedical Inc.)(Brief Article)
December 1, 2002... CardioTech International (Woburn, Massachusetts) said it expects the acquisition of Gish Biomedical (Rancho Santa Margarita, California) to be accretive to earnings within the first year and to dramatically increase revenues. "This acquisition...

MedicalCV (Minneapolis, Minnesota) said it acquired exclusive licensing rights to manufacture and sell a new annuloplasty surgical repair system, the Northrup Universal Heart Valve Repair System, from Segmed (also Minneapolis), a private firm. (Acquisitions).(Brief Article)
December 1, 2002... MedicalCV (Minneapolis, Minnesota) said it acquired exclusive licensing rights to manufacture and sell a new annuloplasty surgical repair system, the Northrup Universal Heart Valve Repair System, from Segmed (also Minneapolis), a private firm....

MIV Therapeutics, Endovasc in new j-v. (Business Developments).(Endovasc Ltd. forms joint venture)
December 1, 2002... Stent/stent coatings developer MIV Therapeutics (Vancouver, British Columbia) and drug therapeutics firm Endovasc (Montgomery, Texas) last month unveiled plans for a joint venture company, named Stentgenix, which will focus on developing...

Centerpulse exits vascular sector. (Business Developments).(divestitures of cardiovascular equipment companies)(Brief Article)
December 1, 2002... Centerpulse (Zurich, Switzerland) said last month that it had closed the sale of its Vascutek Ltd. (Glasgow, Scotland) unit to Terumo (Toyko), which completes its exit from the vascular devices market sector. The $170 million deal was announced...

da Vinci system gets mitral valve ok. (Business Developments).(mitral valve repair equipment approved)(Brief Article)
December 1, 2002... A robotic surgical system already approved for general surgery is venturing into uncharted territory. FDA approval last month clears the way for hospitals to use the da Vinci Surgical System from Intuitive Surgical (Sunnyvale, California) for...

CardioDynamics (San Diego, California), maker of Impedance Cardiography (ICG) technology and manufacturer of BioZ noninvasive digital cardiac function monitoring systems, has signed a distribution agreement with SunTech Medical Instruments (Raleigh, North Carolina), a developer of motion-tolerant noninvasive blood pressure monitoring products and technology. (Agreements).(CardioDynamics International Corp.)(Suntech Medical Instruments Inc.)(Brief Article)
December 1, 2002... CardioDynamics (San Diego, California), maker of Impedance Cardiography (ICG) technology and manufacturer of BioZ noninvasive digital cardiac function monitoring systems, has signed a distribution agreement with SunTech Medical Instruments...

Endovasc (Montgomery, Texas), said a confidentiality agreement that gave GlaxoSmithKline (London) a temporary exclusive right to review and discuss scientific developments associated with Angiogenix, Endovasc's small nicotine isomer product, was terminated. (Agreements).(Endovasc Ltd.)(GlaxoSmithKline PLC)(Brief Article)
December 1, 2002... Endovasc (Montgomery, Texas), said a confidentiality agreement that gave GlaxoSmithKline (London) a temporary exclusive right to review and discuss scientific developments associated with Angiogenix, Endovasc's small nicotine isomer product,...

The French biotechnology company Genfit SA (Lille, France) signed a research collaboration agreement with the pharmaceutical division of Kowa, a Japanese conglomerate whose activities span a number of industries. (Agreements).(Kowa Company Ltd.)(Brief Article)
December 1, 2002... The French biotechnology company Genfit SA (Lille, France) signed a research collaboration agreement with the pharmaceutical division of Kowa, a Japanese conglomerate whose activities span a number of industries. The collaboration is aimed at...

Guidant (Indianapolis, Indiana), a developer of treatments for cardiac and vascular disease, and Genzyme Biosurgery (Cambridge, Massachusetts), a division of Genzyme Corp., unveiled a cross-license agreement related to certain patents for products used in "off-pump" or beating-heart cardiac bypass surgery. (Agreements).(Guidant Corp.)(Brief Article)
December 1, 2002... Guidant (Indianapolis, Indiana), a developer of treatments for cardiac and vascular disease, and Genzyme Biosurgery (Cambridge, Massachusetts), a division of Genzyme Corp., unveiled a cross-license agreement related to certain patents for...

Earlier intervention seen from MRI use in plaque detection. (Market Updates).(magnetic resonance imaging )
December 1, 2002... A new application of magnetic resonance imaging (MRI) can now look at blood vessels directly to find subtle changes in the walls, determining if a patient will develop atherosclerosis, which can lead to stroke or heart attack. "With this...

Prioritizing combination products. (Market Updates).(new product evaluation standards proposed)
December 1, 2002... Panelists from the FDA listened as device and drug manufacturers congratulated the agency on tackling a sticky subject: combination products. Most of the speakers at last month's public hearing--attended by about 150--supported a philosophy of...

Arrhythmia Research Technology. (Personnel File).(Arrhythmia Research Technology Inc. selects corporate officers)(Brief Article)
December 1, 2002... James Rouse, president and CEO, has been elected a director of Arrhythmia Research Technology (Fitchburg, Massachusetts) for a three-year term. The company also reported the appointment of David Garrison as chief financial officer. Garrison...

CryoCath Technologies. (Personnel File).(business executive selected)(Brief Article)
December 1, 2002... Gerard Mahoudeau was named director, European business, of CryoCath Technologies (Montreal, Quebec), which provides cryotherapy products to treat cardiovascular disease. Mahoudeau was named to head the company's 15-person sales and clinical...

Emergency Filtration Products. (Personnel File).(Emergency Filtration Products Inc. selects chief financial officer)(Brief Article)
December 1, 2002... Steve Hanni has been named chief financial officer of Emergency Filtration Products (EFP; Henderson, Nevada). Hanni has worked closely with EFP for the past five years as outside auditor and most recently as a financial and accounting...

Endovasc. (Personnel File).(Endovasc Ltd. selects finance manager)(Brief Article)
December 1, 2002... Robert Horn has joined Endovasc (Montgomery, Texas) as managing director-finance. He formerly was CFO of Surgicare. Endovasc has two cardiovascular drugs in final Phase III human trials.

Oxford BioMedica. (Personnel File).(Oxford BioMedica PLC selects vice president)(Brief Article)
December 1, 2002... Dr. David Higgins has been named vice president for business development for Oxford BioMedica (San Diego, California/Oxford, England). He will join Oxford BioMedica's San Diego subsidiary to head business development in the U.S. Higgins...

Vasomedical. (Personnel File).(Vasomedical Inc. selects chief operating officer)(Brief Article)
December 1, 2002... Gregory Cash has been named president and chief operating officer of Vasomedical (Westbury, New York), manufacturer of enhanced external counterpulsation (EECP) systems used in the treatment of angina, cardiogenic shock, acute myocardial...

Philips gets okay for HeartStart home use. (Product Pipeline).(Philips Medical Systems Inc.)(automated external defibrillators approved for home use)
December 1, 2002... In another in a series of breakthroughs for the defibrillator sector of cardiovascular technology, Philips Medical Systems (Best, the Netherlands) has received FDA clearance for its HeartStart Home Defibrillator, an automated external...

The VAP (Vertical Auto Profile) Expanded Cholesterol Test from Atherotech (Birmingham, Alabama), a cardiodiagnostic company and specialty reference laboratory, steers physicians toward customized drug therapy to fix multiple cholesterol abnormalities rather than just treating elevated LDL cholesterol. (Product Pipeline).(Brief Article)
December 1, 2002... The VAP (Vertical Auto Profile) Expanded Cholesterol Test from Atherotech (Birmingham, Alabama), a cardiodiagnostic company and specialty reference laboratory, steers physicians toward customized drug therapy to fix multiple cholesterol...

Biophan Technologies. (Product Pipeline).(Biophan Technologies Inc.)(Brief Article)
December 1, 2002... Biophan Technologies (Rochester, New York) said it has successfully tested a method for shielding implanted and interoperative medical devices against interference from magnetic resonance imaging (MRI). The tests, conducted in a 1.5 Tesla MRI...

Cardiac Science. (Product Pipeline).(Cardiac Science Inc.)(heart monitors)(Brief Article)
December 1, 2002... Cardiac Science (Irvine, California) reported receiving FDA 510(k) clearance for an advanced version of its monitoring-defibrillation-pacing electrode pads. The new electrode pads are the disposable element of the company's fully automatic...

Cardima. (Product Pipeline).(Cardima Inc.)(ablation microcatheter system )(Brief Article)
December 1, 2002... Cardima (Fremont, California), developer of the Revelation Tx and Revelation Helix microcatheter systems for treating atrial fibrillation (AF), said the FDA has accepted its premarket approval application for the Revelation Tx to treat AF and...

Corvas International. (Product Pipeline).(Brief Article)
December 1, 2002... Corvas International (San Diego, California) began a multicenter Phase II program to investigate the safety and efficacy of recombinant nematode anticoagulant protein c2 (rNAPc2), in patients with acute coronary syndromes. The objective of the...

CryoCath Technologies. (Product Pipeline).(cryoablation catheter )(Brief Article)
December 1, 2002... CryoCath Technologies (Montreal, Quebec), which focuses on cryotherapy products to treat cardiovascular disease, submitted to the FDA the fifth and final module in the company's PMA filing plan for the Freezor Cardiac Cryoablation System. The...

Estracure. (Product Pipeline).(Estracure Inc. develops restenosis prevention drug)(Brief Article)
December 1, 2002... Estracure (Montreal, Quebec) said it has received approval from Health Canada to initiate a Phase II trial of 17-beta-Estradiol in the prevention of restenosis in patients following percutaneous transluminal coronary angioplasty (PTCA) and...

Guidant. (Product Pipeline).(Guidant Corp. develops new stent platform)(Brief Article)
December 1, 2002... Guidant (Indianapolis, Indiana) said a premarket approval application was submitted to the FDA for the investigational Multi-Link Vision Coronary Stent System, the company's seventh-generation Multi-Link stent platform for the treatment of...

Lexicon Genetics. (Product Pipeline).(Lexicon Genetics Inc. develops thrombosis prevention drug)(Brief Article)
December 1, 2002... Lexicon Genetics (The Woodlands, Texas) said it has discovered a target for the development of drugs to reduce formation of blood clots without increasing bleeding, a common side effect of current therapies such as aspirin that are used to...

MedicalCV. (Product Pipeline).(MedicalCV Inc. develops larger artificial heart valve sizes)(Brief Article)
December 1, 2002... MedicalCV (Minneapolis, Minnesota) said the FDA has issued premarket approval (PMA) for two additional sizes of the company's Omnicarbon heart valve, sizes 21 aortic and 25 mitral. With the addition of these two sizes, the Omnicarbon aortic and...

Medtronic (Minneapolis, Minnesota) reported the first worldwide implant of the InSync III Marquis implantable cardioverter-defibrillator (ICD) system. (Product Pipeline).(Medtronic Inc.)(Brief Article)
December 1, 2002... Medtronic (Minneapolis, Minnesota) reported the first worldwide implant of the InSync III Marquis implantable cardioverter-defibrillator (ICD) system. This is the company's fifth and most advanced cardiac resynchronization therapy device for...

Millennium Pharmaceuticals. (Product Pipeline).(Millennium Pharmaceuticals Inc. evaluate the safety of Integrilin)
December 1, 2002... Millennium Pharmaceuticals (Cambridge, Massachusetts) initiated a Phase III trial of Integrilin in patients experiencing an ST-segment elevation myocardial infarction (STEMI), or heart attack. The trial, known as Advance MI (ADdressing the...

NicOx. (Product Pipeline).(NicOx S.A. develops cardiac drug)(Brief Article)
December 1, 2002... NicOx (Sophia Antipolis, France) said its investigational new drug application was accepted by the FDA for the Phase II testing of NCX 4016, its nitric oxide-donating derivative of aspirin, in development for the treatment and prevention of...

Non-Invasive Monitoring Systems. (Product Pipeline).(Non-Invasive Monitoring Systems Inc. )(Brief Article)
December 1, 2002... Non-Invasive Monitoring Systems (North Bay Village, Florida) released results of a study showing that the acceleration therapeutics AT101 may be a superior method of cardiopulmonary resuscitation when compared to traditional methods. The AT101...

Quinton Cardiology Systems (Bothell, Washington) said it began shipping Q-Stress version 3.0 systems using Japanese characters to its Japanese distributor, Nihon Kohden. (Product Pipeline).(Brief Article)
December 1, 2002... Quinton Cardiology Systems (Bothell, Washington) said it began shipping Q-Stress version 3.0 systems using Japanese characters to its Japanese distributor, Nihon Kohden. The companies announced plans in June to jointly develop a version of...

Response Biomedical (Vancouver, British Columbia) reported positive results from an independent preclinical study of Ramp tests for troponin I and CK-MB, two cardiac markers used in the early detection of heart attack. (Product Pipeline).(Response Biomedical Corp.)(Brief Article)
December 1, 2002... Response Biomedical (Vancouver, British Columbia) reported positive results from an independent preclinical study of Ramp tests for troponin I and CK-MB, two cardiac markers used in the early detection of heart attack. Both additional Ramp...

Scion Cardio-Vascular. (Product Pipeline).(Brief Article)
December 1, 2002... Scion Cardio-Vascular (Miami, Florida) received CE marking for its Clo-Sur P.A.D. hemostasis device. The Clo-Sur P.A.D. is a topical, non-invasive device used for rapid control of bleeding associated with catheter removal following a...

St. Jude Medical. (Product Pipeline).(angiography catheters )(Brief Article)
December 1, 2002... St. Jude Medical (St. Paul, Minnesota) launched its 4F Spyglass angiography catheters and Maximum introducer kits for sale in the Japanese market. The St. Jude Medical 4F Spyglass features proprietary braiding technology designed for...

Synthetic Blood International (SYBD; Costa Mesa, California) scientists made two Oxycyte presentations to their peers at the annual meeting of the American Association of Pharmaceutical Scientists in Toronto, Ontario. (Product Pipeline).(Brief Article)
December 1, 2002... Synthetic Blood International (SYBD; Costa Mesa, California) scientists made two Oxycyte presentations to their peers at the annual meeting of the American Association of Pharmaceutical Scientists in Toronto, Ontario. Oxycyte is SYBD's...