Cardiovascular Device Update articles from October 2004

Cardiovascular Device Update archives from October 2004

Trends in management of heart failure, arrhythmia in Europe.(CDU at the European Society of Cardiology Congress)
October 1, 2004... MUNICH, Germany -- Congestive heart failure (CHF) is a major and growing worldwide public health problem that is creating demands for a wide range of diagnostic, therapeutic and patient-monitoring technologies in Europe and most other developed...

Sessions eye diabetes' impact on heart patients.(ESC notebook)
October 1, 2004... Several sessions held during last month's congress of the European Society of Cardiology (ESC; Sophia Antipolis, France) in Munich, Germany, focused on the diabetic state of patients with coronary artery disease. Presenters demonstrated that in...

GE Healthcare calls its Vivid i 'the virtual stethoscope of future'.
October 1, 2004... GE Healthcare (Waukesha, Wisconsin) has unveiled what it touted as the "visual stethoscope of the future," a new, miniaturized cardiovascular ultrasound system it said was so small and lightweight that it will transform the way doctors see and...

FDA clears Philips' HeartStart defibrillator for over-the-counter sales.
October 1, 2004... WASHINGTON -- The FDA has granted clearance to a product that may shock some consumers--literally. Philips Medical Systems (Bothell, Washington) got the nod from the FDA in mid-September to market its HeartStart Home Defibrillator over the...

Abbott enrolls first patient in study of its ZoMaxx DES.
October 1, 2004... The Abbott Vascular Devices (Redwood City, California) division of Abbott Laboratories (Abbott Park, Illinois) reported in mid-September that it had enrolled the first patient in its ZOMAXX I drug-eluting coronary stent clinical trial. ZOMAXX I...

CoreValve begins trial of ReValving System.(Report from Europe)
October 1, 2004... CoreValve (Paris) will begin a European Phase I clinical trial of its ReValving System at The Heart Center (Seigburg, Germany), having received institutional review board (IRB) approval at that institution. The trial calls for use of the...

Three centers buy Abiomed device.(Report from Europe)(Herzzentrum Nordrhein-Westfalen)(Azienda Ospedaliera Niguarda Ca'Granda )(University Hospital Lund )(Brief Article)
October 1, 2004... Abiomed (Danvers, Massachusetts) said the first European orders for its AB5000 Circulatory Support System have been placed by Herzzentrum Nordrhein-Westfalen (Bad Oeynhausen, Germany), Azienda Ospedaliera Niguarda Ca'Granda (Milan, Italy) and...

New driver for artificial heart.(Report from Europe)(SynCardia Systems )(Medos Medizintechnik AG)(Brief Article)
October 1, 2004... SynCardia Systems (Tucson, Arizona), a developer of biomechanical cardiac replacement and mechanical circulatory support devices, has licensed a new smaller driver for its CardioWest Total Artificial Heart (TAH) from Medos Medizintechnik AG...

Automated blood processing systems developer Haemonetics (Braintree, Massachusetts) reported that it has acquired all of the blood conservation technologies assets of Harvest Technologies (Plymouth, Massachusetts).(Acquisitions)
October 1, 2004... Automated blood processing systems developer Haemonetics (Braintree, Massachusetts) reported that it has acquired all of the blood conservation technologies assets of Harvest Technologies (Plymouth, Massachusetts), a company that designs...

Medtronic (Minneapolis) reported acquiring the assets of Coalescent Surgical (Sunnyvale, California), a developer of technologies designed to connect vessels safely without sutures.(Acquisitions)(Brief Article)
October 1, 2004... Medtronic (Minneapolis) reported acquiring the assets of Coalescent Surgical (Sunnyvale, California), a developer of technologies designed to connect vessels safely without sutures. Financial terms of the purchase were not disclosed. Since the...

Abiomed eyes HDE as route for AbioCor.(Business Developments)
October 1, 2004... Abiomed (Danvers, Massachusetts) last month submitted to the FDA an application for market approval of its AbioCor implantable replacement heart under a Humanitarian Device Exemption (HDE). Approval under an HDE would make the AbioCor...

Memry funds joint coated-stent effort.(Business Developments)
October 1, 2004... Drug-eluting stent (DES) technologies for use in the coronary arteries provide a clear and direct path to similar coated-stent use in the peripheral vasculature, and that is a wave that Memry (Bethel, Connecticut) says it refuses to miss....

U.S. unit for CoreValve.(Business Developments)
October 1, 2004... CoreValve (Paris), developer of the CoreValve delivery system for percutaneous heart valve replacement based on a catheter and self-expanding stent approach on a beating heart, which avoids open-heart surgery, has established U.S. operations in...

Catalyst Pharma Group (Pasadena, California) has entered into a strategic partnership with Spacelabs Medical Data (Issaquah, Washington).(Agreements)(Brief Article)
October 1, 2004... Catalyst Pharma Group (Pasadena, California) has entered into a strategic partnership with Spacelabs Medical Data (Issaquah, Washington). The Medical Data division of Spacelabs provides regulatory-compliant core ECG, Holter and other cardiac...

CTI PET Systems (CPS; Knoxville, Tennessee), a unit of CTI Molecular Imaging, and Toshiba America Medical Systems (TAMS; Tustin, California), have signed an agreement to jointly develop a line of integrated positron emission tomography(PET)/computed tomography (CT) systems for Toshiba to distribute in Japan.(Agreements)(Brief Article)
October 1, 2004... CTI PET Systems (CPS; Knoxville, Tennessee), a unit of CTI Molecular Imaging, and Toshiba America Medical Systems (TAMS; Tustin, California), have signed an agreement to jointly develop a line of integrated positron emission...

IT&E International Group (San Diego) reported that it has signed a long-term, multi-country agreement with Cordis (Miami Lakes, Florida), a business of Johnson & Johnson (New Brunswick, New Jersey), for expanded FDA regulatory compliance services.(Agreements)(Brief Article)
October 1, 2004... IT&E International Group (San Diego) reported that it has signed a long-term, multi-country agreement with Cordis (Miami Lakes, Florida), a business of Johnson & Johnson (New Brunswick, New Jersey), for expanded FDA regulatory compliance...

Merit Medical Systems (South Jordan, Utah), a maker of disposable products used primarily in cardiology and radiology procedures, has signed a supplier agreement with Premier Purchasing Partners, the group purchasing organization of Premier (San Diego), an alliance of hospitals and health care organizations.(Agreements)(Brief Article)
October 1, 2004... Merit Medical Systems (South Jordan, Utah), a maker of disposable products used primarily in cardiology and radiology procedures, has signed a supplier agreement with Premier Purchasing Partners, the group purchasing organization of Premier...

Neoprobe (Dublin, Ohio), a diversified developer of oncology and cardiovascular surgical and diagnostic products, reported the extension of its current distribution arrangement with Century Medical (Tokyo) to provide sales coverage for the Quantix products in Japan in addition to the neo2000 gamma detection system.(Agreements)(Brief Article)
October 1, 2004... Neoprobe (Dublin, Ohio), a diversified developer of oncology and cardiovascular surgical and diagnostic products, reported the extension of its current distribution arrangement with Century Medical (Tokyo) to provide sales coverage for the...

Siemens Medical Solutions (Malvern, Pennsylvania) has signed a two-year research collaboration agreement with The Heart Center of Indiana (THCI; Indianapolis).(Agreements)(Brief Article)
October 1, 2004... Siemens Medical Solutions (Malvern, Pennsylvania) has signed a two-year research collaboration agreement with The Heart Center of Indiana (THCI; Indianapolis). Through the agreement, THCI will leverage Siemens' most advanced MRI technologies to...

Study: ICDs lower out-of-hospital SCD.(Market Updates)(Implantable cardioverter defibrillator)
October 1, 2004... Implantable cardioverter defibrillator (ICD) implantation may contribute to a lower incidence of ventricular fibrillation (VF)-related out-of-hospital cardiac arrest treated by emergency medical services (EMS), according to a study published in...

Panel discusses trial design for CPR devices.(Cardiopulmonary resuscitation)
October 1, 2004... In what seemed like another part of the agency's ongoing effort to make the government's regulatory process more transparent for both industry and consumers, the FDA's Circulatory System Devices Panel held an investigational panel meeting in...

Abiomed.(Personnel File)(Frank Menzler )(Brief Article)
October 1, 2004... Abiomed (Danvers, Massachusetts) named Frank Menzler general manager for Abiomed BV, the company's European division. Menzler most recently was marketing manager for cardiac surgery for Guidant Europe and was a co-founder of Impella...

Biosite.(Personnel File)(Brief Article)
October 1, 2004... Robin Weiner has joined Biosite (San Diego) as vice president, regulatory and government affairs. She most recently served as vice president, clinical and regulatory affairs at Quidel, prior to which she was with Scripps Clinic and Research...

Guilford Pharmaceuticals.(Personnel File)(Craig Smith)(Brief Article)
October 1, 2004... Craig Smith, MD, will retire as chairman, president and CEO of Guilford Pharmaceuticals (Baltimore). Smith, a co-founder of Guilford, will remain in those positions until the company's next annual meeting, unless a successor is identified...

MedicalCV.(Personnel File)(Marc Flores )(Brief Article)
October 1, 2004... Marc Flores has been named president, CEO and a member of the board of directors of MedicalCV (Minneapolis). Lawrence Horsch, who had been serving as acting CEO, will remain chairman of the board. Flores most recently served as vice president...

SynCardia Systems.(Personnel File)(Carole Marcot )(Brief Article)
October 1, 2004... Carole Marcot has joined SynCardia Systems (Tucson, Arizona) as vice president of quality and regulatory affairs. Marcot most recently served as vice president, regulatory affairs and quality systems at Ventana Medical Systems. SynCardia, a...

Expanded indication for Guidant devices.(Product Pipeline)
October 1, 2004... Guidant (Indianapolis) said that the FDA has approved an expanded indication for the company's portfolio of cardiac resynchronization therapy defibrillators (CRT-D). The expanded indication makes Guidant's CRT-D devices available to thousands...

Advanced Stent Technologies (AST; Pleasanton, California), a developer of bifurcated stent technologies, reported receiving FDA conditional approval to incorporate its bare-metal Petal coronary bifurcation stent and delivery system into its ongoing U.S. BOSS clinical trial and has enrolled the first patient at the Lindner Clinical Trial Center (Cincinnati).(Product Pipeline)(Brief Article)
October 1, 2004... Advanced Stent Technologies (AST; Pleasanton, California), a developer of bifurcated stent technologies, reported receiving FDA conditional approval to incorporate its bare-metal Petal coronary bifurcation stent and delivery system into its...

Analogic.(Product Pipeline)(Brief Article)
October 1, 2004... Analogic (Peabody, Massachusetts) reported the formal market release of the Lifegard ICG Patient Monitor. The Lifegard ICG provides continuous cardiac output by measuring the ICG (impedance cardiogram) to calculate cardiac output. The monitor...

AngioScore.(Product Pipeline)(Brief Article)
October 1, 2004... AngioScore (Alameda, California) reported receiving the CE mark for its flagship AngioSculpt scoring balloon catheter. The company will begin shipment of the product to its distributors in Europe this month. The AngioSculpt scoring balloon...

Boston Scientific (Natick, Massachusetts) reported that enrollment has begun in its ATLAS clinical trial, the first trial using its new Liberte coronary stent as a platform for the company's paclitaxel-eluting coronary stent system.(Product Pipeline)
October 1, 2004... Boston Scientific (Natick, Massachusetts) reported that enrollment has begun in its ATLAS clinical trial, the first trial using its new Liberte coronary stent as a platform for the company's paclitaxel-eluting coronary stent system. Taxus...

Cardica (Redwood City, California) reported clinical trial results from a multi-center study of its C-Port Distal Anastomosis System, technology used for creating a mechanical connection between two vessels during coronary artery bypass graft surgery.(Product Pipeline)(Brief Article)
October 1, 2004... Cardica (Redwood City, California) reported clinical trial results from a multi-center study of its C-Port Distal Anastomosis System, technology used for creating a mechanical connection between two vessels during coronary artery bypass graft...

CardioDynamics (San Diego), manufacturer of BioZ Impedance Cardiography (ICG) non-invasive cardiac monitoring systems, reported the results of its PREDICT (Prospective Evaluation and Identification of Decompensation by ICG Test) study, demonstrating a significant relationship between BioZ ICG parameters and the occurrence of a major heart failure outcome.(Product Pipeline)(Brief Article)
October 1, 2004... CardioDynamics (San Diego), manufacturer of BioZ Impedance Cardiography (ICG) non-invasive cardiac monitoring systems, reported the results of its PREDICT (Prospective Evaluation and Identification of Decompensation by ICG Test) study,...

Dade Behring.(Product Pipeline)(Brief Article)
October 1, 2004... Dade Behring (Deerfield, Illinois) said a study in the Sept. 14 issue of Circulation concluded that information regarding platelet function obtained with its PFA-100 analyzer may help in the risk stratification of patients presenting with...

Edwards Lifesciences (Irvine, California) reported that the company has initiated a pivotal clinical trial of its next-generation Carpentier-Edwards BioPhysio aortic valve, which it said is the only replacement heart valve designed to mimic the physiologic motion of a natural heart valve.(Product Pipeline)(Brief Article)
October 1, 2004... Edwards Lifesciences (Irvine, California) reported that the company has initiated a pivotal clinical trial of its next-generation Carpentier-Edwards BioPhysio aortic valve, which it said is the only replacement heart valve designed to mimic the...

EP MedSystems.(Product Pipeline)(Brief Article)
October 1, 2004... EP MedSystems (West Berlin, New Jersey) reported that it had received market clearance from the FDA for an enhancement to its EP-4 Computerized Cardiac Stimulator allowing the physician to stimulate the heart using either constant current or...

ev3.(Product Pipeline)(Brief Article)
October 1, 2004... ev3 (Plymouth, Minnesota) said it has received CE mark approval for use of its Protege GPS Nitinol Self-Expanding Tapered Stent for treatment of carotid artery disease. The Protege GPS stents are designed to provide a more appropriate fit to...

Medtronic.(Product Pipeline)(Brief Article)
October 1, 2004... Medtronic (Minneapolis) reported FDA approval and U.S. market release of the Sprint Fidelis family of defibrillation leads. At 6.6 Fr in size, Sprint Fidelis leads are the world's smallest right ventricular defibrillation leads, the company...

Medtronic Vascular (Santa Rosa, California) reported that it has completed patient enrollment in the ENDEAVOR III clinical trial in the U.S.(Product Pipeline)(Brief Article)
October 1, 2004... Medtronic Vascular (Santa Rosa, California) reported that it has completed patient enrollment in the ENDEAVOR III clinical trial in the U.S. The data from the ENDEAVOR III trial will be used to support U.S. product approval of the company's...

MIV Therapeutics.(Product Pipeline)(Brief Article)
October 1, 2004... MIV Therapeutics (Vancouver, British Columbia) reported the completion of in vivo safety studies on its biocompatible Hydroxyapatite (HAp) nanofilm coating, designated for passive application on cardiovascular stents and other implantable...

Siemens Medical Solutions.(Product Pipeline)(Brief Article)
October 1, 2004... Siemens Medical Solutions (Malvern, Pennsylvania) said its Angiography and X-ray Division has introduced Interventional Cardiac 3D (IC3D) technology to create 3-D images of the coronary vessels in the heart. When paired with an Axiom Artis...

Smiths Medical.(Product Pipeline)(Brief Article)
October 1, 2004... Smiths Medical (Rockland, Massachusetts) has introduced the Snuggle Warm Convective Warming Sterile Cardiac Blanket. Designed to maintain patient temperature during cardiac surgery and help the patient arrive in the recovery room or intensive...

St. Jude Medical.(Product Pipeline)(Brief Article)
October 1, 2004... St. Jude Medical (St. Paul, Minnesota) reported European CE mark approval for the QuickSite 1056T bipolar left-heart pacing lead. The company said it is the first cardiac resynchronization therapy (CRT) lead to offer physicians a composite body...

Vasomedical (Westbury, New York) said that two separate presentations on the clinical improvements achieved with EECP (enhanced external counterpulsation) therapy in the treatment of heart disease were presented at the European Society of Cardiology congress.(Product Pipeline)(Brief Article)
October 1, 2004... Vasomedical (Westbury, New York) said that two separate presentations on the clinical improvements achieved with EECP (enhanced external counterpulsation) therapy in the treatment of heart disease were presented at the European Society of...

Vitatron (Arnhem, the Netherlands), a European-based subsidiary of Medtronic (Minneapolis), reported the recent FDA approval and U.S. launch of the Vitatron T-series pacemaker, an advanced implantable heart device based on a digital processing platform.(Product Pipelines)(Brief Article)
October 1, 2004... Vitatron (Arnhem, the Netherlands), a European-based subsidiary of Medtronic (Minneapolis), reported the recent FDA approval and U.S. launch of the Vitatron T-series pacemaker, an advanced implantable heart device based on a digital processing...

Zargis Medical (Princeton, New Jersey), a subsidiary of Speedus, said it has received FDA clearance to include a graphical display of the median energy level, timing and duration of suspected heart murmurs during specific segments of the diastolic and systolic intervals of heartbeats recorded through the Zargis Acoustic Cardioscan.(Product Pipeline)(Brief Article)
October 1, 2004... Zargis Medical (Princeton, New Jersey), a subsidiary of Speedus, said it has received FDA clearance to include a graphical display of the median energy level, timing and duration of suspected heart murmurs during specific segments of the...