Cardiovascular Device Update articles from August 2002

Cardiovascular Device Update archives from August 2002

Advances in therapies driving growth in cardiac risk assessment.
August 1, 2002... WASHINGTON--Risk assessment for cardiovascular disease is a rapidly evolving field, encompassing in vitro diagnostics as well as imaging modalities and physiological measurements. The demand for more powerful risk assessment techniques is being...

Growth factor useful versus claudication. (From the Lab).(recombinant fibroblast growth factor-2)
August 1, 2002... Claudication--muscular leg pain when walking--is a hallmark of peripheral artery disease. It's akin to coronary artery disease but involves limbs, not heart. "Peripheral artery disease," said interventional cardiologist Robert Lederman, "is...

Natriuretic peptides grow as CHF markers. (Report from Europe).(congestive heart failure)
August 1, 2002... Congestive heart failure (CHF) is a chronic progressive disease with physical symptoms such as shortness of breath, non-specific fatigue and fluid retention. Definitive diagnosis normally relies on functional investigations such as ECG and...

Arrhythmia Research Technology (ART: Fitchburg, Massachusetts) reported that its subsidiary, Micron Acquisition, has broken off talks with Select Engineering (also Fitchburg) concerning Micron's purchase of certain operating assets of Select. (Acquisitions).(Brief Article)
August 1, 2002... Arrhythmia Research Technology (ART: Fitchburg, Massachusetts) reported that its subsidiary, Micron Acquisition, has broken off talks with Select Engineering (also Fitchburg) concerning Micron's purchase of certain operating assets of Select....

Serologicals (Norcross, Georgia) reported completing the integration of Intergen's (Purchase, New York) operations into its activities, by combining the administrative, commercial, manufacturing and research and development operations of the two companies. (Acquisitions).(Brief Article)
August 1, 2002... Serologicals (Norcross, Georgia) reported completing the integration of Intergen's (Purchase, New York) operations into its activities, by combining the administrative, commercial, manufacturing and research and development operations of the...

Wipro (Santa Clara, California) said its board of directors approved an agreement to acquire GE Medical Systems Information Technologies Private Ltd. (GEMSIT Private Ltd.; Bangalore, India). (Acquisitions).(Brief Article)
August 1, 2002... Wipro (Santa Clara, California) said its board of directors approved an agreement to acquire GE Medical Systems Information Technologies Private Ltd. (GEMSIT Private Ltd.; Bangalore, India). The transaction is valued at approximately $5.73...

CardioGenesis makes another run at FDA. (Business Developments).
August 1, 2002... Looking to reverse its U.S. regulatory fortunes in regard to percutaneous myocardial revascularization (PMR) therapy for the relief of angina, CardioGenesis (Foothill Ranch, California) is attempting for the second time to send a premarket...

eResearch Technology. (Agreements).(Brief Article)
August 1, 2002... * eResearch Technology (eRT; Philadelphia, Pennsylvania), a provider of centralized electrocardiographic (ECG) collection and interpretation services, has received a multimillion-dollar extension to an existing agreement with a major...

MaxCyte (Rockville, Maryland) has entered into a research agreement with Angiogene (Montreal, Quebec) to develop a recuperative treatment for congestive heart failure caused by myocardial infarction using MaxCyte's GT cell-loading system. (Agreements).(Brief Article)
August 1, 2002... * MaxCyte (Rockville, Maryland) has entered into a research agreement with Angiogene (Montreal, Quebec) to develop a recuperative treatment for congestive heart failure caused by myocardial infarction using MaxCyte's GT cell-loading system....

Medwave (Arden Hills, Minnesota) has entered into an agreement with the University of Utah (Salt Lake City, Utah), Division of Pediatric Cardiology, to conduct a clinical study at Primary Children's Medical Center (also Salt Lake City). (Agreements).(Brief Article)
August 1, 2002... * Medwave (Arden Hills, Minnesota) has entered into an agreement with the University of Utah (Salt Lake City, Utah), Division of Pediatric Cardiology, to conduct a clinical study at Primary Children's Medical Center (also Salt Lake City). The...

Study cites positive cardiac impact of HRT. (Market Updates).(hormone replacement therapy)
August 1, 2002... Recent headlines splashed across the nation's newspapers have thrown into doubt the use of hormone replacement therapy (HRT) for treatment of menopause, citing the Women's Health Initiative (WHI) study indicting HRT as causing increased heart...

CardioTech International. (Personnel File).(Brief Article)
August 1, 2002... * Caroline Hammond has been named director of new business development of the Catheter and Disposables Technology (CDT) business of CardioTech International (Woburn, Massachusetts). Additionally, Daniel Ranum has been named senior project...

CardioVention. (Personnel File).(Brief Article)
August 1, 2002... * Robert McCulloch was named chief financial officer as well as vice president of finance and administration for CardioVention (Santa Clara, California), a developer of minimally invasive surgical technologies. Previously, McCulloch was vice...

Novoste. (Personnel File).(Brief Article)
August 1, 2002... * Andrew Green was promoted from director of regulatory affairs to vice president of regulatory affairs for Novoste (Norcross, Georgia), which develops vascular brachytherapy technology and systems.

OmniSonics Medical Technologies. (Personnel File).(Brief Article)
August 1, 2002... * Maggie Pax was appointed vice president of marketing and Kathleen Dennis, director of quality assurance for OmniSonics Medical Technologies (Wilmington, Massachusetts). Most recently Pax was vice president of business development and...

Spectranetics. (Personnel File).(Brief Article)
August 1, 2002... * Bruce Ross was promoted from vice president of sales, marketing and services to acting chief operating officer for Spectranetics (Colorado Springs, Colorado). Also, Guy Childs was promoted from director of finance to acting chief financial...

Volcano Therapeutics. (Personnel File).(Brief Article)
August 1, 2002... * Scott Huennekens was named president and CEO of Volcano Therapeutics (Laguna Niguel, California). He previously was president and CEO of Digirad. Volcano Therapeutics develops products for the detection and treatment of vulnerable plaques in...

InSync ICD for heart failure gets FDA nod. (Product Pipeline).(Medtronic Inc.)
August 1, 2002... The beat goes on for Medtronic (Minneapolis, Minnesota) which last month received FDA approval for its InSync ICD (implantable cardioverter defibrillator) system for heart failure received FDA approval, a little over four months after winning a...

Camtronics Medical Systems (Hartland, Wisconsin), a subsidiary of Analogic (Peabody, Massachusetts), unveiled a new release of its Vericis PhysioLog Hemodynamic Monitoring and Data Management System that features patient data collection, waveform visualization, and customizable management reports. (Product Pipeline).(Brief Article)
August 1, 2002... * Camtronics Medical Systems (Hartland, Wisconsin), a subsidiary of Analogic (Peabody, Massachusetts), unveiled a new release of its Vericis PhysioLog Hemodynamic Monitoring and Data Management System that features patient data collection,...

Cardima. (Product Pipeline).(Brief Article)
August 1, 2002... * Cardima (Fremont, California) said that six-month follow up on 80 patients enrolled in its Revelation Tx trial to treat atrial fibrillation (AF) has been completed, and that 97% of patients using the Revelation Tx microcatheter system...

CardioFocus. (Product Pipeline).(Brief Article)
August 1, 2002... * CardioFocus (Norton, Massachusetts) received FDA permission to begin a Phase I trial of its Light Ring catheter to treat atrial fibrillation (AF). The Light Ring catheter uses infrared laser light to treat AF in patients who have been...

CardioGenesis (Foothill Ranch, California), a developer of transmyocardial revascularization (TMR) and percutaneous myocardial revascularization (PMR), presented at the International Society of Minimally Invasive Cardiac Surgery meeting in New York, data from a TMR study using its Holmium:YAG laser was. (Product Pipeline).(Brief Article)
August 1, 2002... * CardioGenesis (Foothill Ranch, California), a developer of transmyocardial revascularization (TMR) and percutaneous myocardial revascularization (PMR), presented at the International Society of Minimally Invasive Cardiac Surgery meeting in...

Cordis (Miami Lakes, Florida), a unit of Johnson & Johnson (New Brunswick, New Jersey), said the FDA has given it approval to market the Bx Sonic Over-the-Wire Coronary Stent. (Product Pipeline).(Brief Article)
August 1, 2002... * Cordis (Miami Lakes, Florida), a unit of Johnson & Johnson (New Brunswick, New Jersey), said the FDA has given it approval to market the Bx Sonic Over-the-Wire Coronary Stent. The product is indicated for improving coronary luminal diameter...

CryoCath Technologies (Montreal, Quebec) received FDA acceptance of the first of five modules of its PMA filing for the Freezor Cardiac Cryoablation system. (Product Pipeline).(Brief Article)
August 1, 2002... * CryoCath Technologies (Montreal, Quebec) received FDA acceptance of the first of five modules of its PMA filing for the Freezor Cardiac Cryoablation system. The module contained pre-clinical data that demonstrated the safety and efficacy of...

Edwards Lifesciences. (Product Pipeline).(Brief Article)
August 1, 2002... * Edwards Lifesciences (Irvine, California) received FDA premarket approval for its Carpentier-Edwards S.A.V. porcine replacement heart valve. The Carpentier-Edwards S.A.V. Bioprosthesis allows for a supra-annular implantation--above a...

Endovasc (Montgomery, Texas) filed a patent application for a method for stimulating growth of new blood vessels in the heart and limbs by releasing therapeutic amounts of its new drug, Angiogenix, a nicotine acetylcholine receptor agonist, from a stent leading to an ischemic area by the heart or limbs. (Product Pipeline).(Brief Article)
August 1, 2002... * Endovasc (Montgomery, Texas) filed a patent application for a method for stimulating growth of new blood vessels in the heart and limbs by releasing therapeutic amounts of its new drug, Angiogenix, a nicotine acetylcholine receptor agonist,...

EP MedSystems. (Product Pipeline).(Brief Article)
August 1, 2002... * EP MedSystems (Mt. Arlington, New Jersey) received CE mark clearance for its 30-joule Alert Companion, a biphasic low energy defibrillation device designed for use in conjunction with catheters for internal defibrillation of the heart....

Hemonix (Beaverton, Oregon) presented a new noninvasive blood pressure monitoring technology at the American Society of Hypertension conference in New York. (Product Pipeline).(Brief Article)
August 1, 2002... * Hemonix (Beaverton, Oregon) presented a new noninvasive blood pressure monitoring technology at the American Society of Hypertension conference in New York. The new monitor and cuff, called the Hemo View PeriVasc (for peripheral vascular),...

Instromedix (San Diego, California), a business of Card Guard (Schaffhausen, Switzerland), is launching the King of Hearts Express AF, a 30-day cardiac event monitor with atrial fibrillation (AF) auto-trigger capabilities. (Product Pipeline).(Brief Article)
August 1, 2002... * Instromedix (San Diego, California), a business of Card Guard (Schaffhausen, Switzerland), is launching the King of Hearts Express AF, a 30-day cardiac event monitor with atrial fibrillation (AF) auto-trigger capabilities. Along with being...

International Medical Innovations. (Product Pipeline).(Brief Article)
August 1, 2002... * International Medical Innovations (IMI; Toronto, Ontario) said the FDA approved its Cholesterol 1,2,3 test, which is designed to measure skin cholesterol in adults with severe coronary artery disease (CAD). Other tests currently used by...

Novoste. (Product Pipeline).(Brief Article)
August 1, 2002... * Novoste (Norcross, Georgia) received FDA investigational device exemption (IDE) approval to begin the Beta Radiation for treatment of Arterial-Venous graft Outflow (BRAVO) clinical trial, a randomized, multicenter, placebo-controlled study...

PLC Systems (Franklin, Massachusetts), a developer of carbon dioxide (C[O.sub.2]) laser revascularization technology used to treat patients with severe angina said a study published in the June 15 issue of the American Journal of Cardiology confirmed previous safety and effectiveness results of transmyocardial revascularization (TMR). (Product Pipeline).(Brief Article)
August 1, 2002... * PLC Systems (Franklin, Massachusetts), a developer of carbon dioxide (C[O.sub.2]) laser revascularization technology used to treat patients with severe angina said a study published in the June 15 issue of the American Journal of Cardiology...

Possis Medical. (Product Pipeline).(Brief Article)
August 1, 2002... * Possis Medical (Minneapolis, Minnesota) filed an investigational device exemption supplement with the FDA to introduce a microcatheter into the TIME 1 IDE clinical trial for ischemic stroke. The study aims to characterize the safety and...

Qmed. (Product Pipeline).(Brief Article)
August 1, 2002... * Qmed (Laurence Harbor, New Jersey) began its initiative for coronary artery disease in the Medicare Coordinated Care Demonstration (MCCD) project. MCCD will test the feasibility of reimbursing disease management in the Medicare...

Thoratec. (Product Pipeline).(Brief Article)
August 1, 2002... * Thoratec (Pleasanton, California) reported implantation of nearly 6,000 of its ventricular assist devices (VADs), including its Ventricular Assist Device System and the HeartMate LVAS (Left Ventricular Assist System). "We believe it...

Vascutek. (Product Pipeline).(Brief Article)
August 1, 2002... * Vascutek (Glasgow, Scotland), a unit of Centerpulse (Zurich, Switzerland) that develops polyester and ePTFE vascular grafts used to treat arterial disease, received FDA clearance for its Gelweave Valsalva graft. The graft is designed for use...

Vasomedical (Westbury, New York) said data from a retrospective analysis of its enhanced external counterpulsation (EECP) system presented at the recent annual meeting of the American Diabetes Association (Alexandria, Virginia) showed that the system reduced the frequency and severity of angina in diabetic patients with congestive heart failure (CHF). (Product Pipeline).(Brief Article)
August 1, 2002... * Vasomedical (Westbury, New York) said data from a retrospective analysis of its enhanced external counterpulsation (EECP) system presented at the recent annual meeting of the American Diabetes Association (Alexandria, Virginia) showed that...