Cardiovascular Device Update articles from June 2004

Cardiovascular Device Update archives from June 2004

Complex technologies sharpen focus on improved diagnostics.
June 1, 2004... SAN FRANCISCO, California -- The field of electrophysiology has changed dramatically over the past three decades, as the management of arrhythmias, or irregular heart rhythms, has evolved from simple pacemakers in the early 1970s to highly...

NEJM publishes data from two significant heart failure trials.(New England Journal of Medicine)
June 1, 2004... Data from two significant heart failure trials--COMPANION and DEFINITE--was published in the May 20 issue of the New England Journal of Medicine (NEJM), and both trials also were the subject of presentations at the Heart Rhythm Society's...

Guidant CEO Dollens reveals plans to retire by the end of the year.(chief executive officer)(Ronald Dollens)
June 1, 2004... Cardiovasular device powerhouse Guidant (Indianapolis, Indiana) reported on May 18 that Ronald Dollens, the company's president and chief executive officer and a guiding force for the company since its founding, will retire on Dec. 31. The...

Two firms' cardiac diagnostic tests are cleared for sale by FDA.
June 1, 2004... Two companies received FDA clearance last month for new cardiac diagnostic tests that could greatly aid in the rapid detection of a potential heart attack, and one in particular could be the wave of the future for emergency room diagnosis of...

Arrhythmias focus of UK service framework.(Report from Europe)
June 1, 2004... The UK Department of Health has launched a consultation on a new chapter of the National Service Framework (NSF) on Coronary Heart Disease. The new area will cover heart arrhythmias, which will form an important part of the heart disease...

Microtek Medical Holdings (Microtek; Columbus, Mississippi) said that its newly formed Netherlands-based subsidiary, Microtek Medical BV, has acquired International Medical Products BV (IMP) and its affiliates, from Cardinal Health (Dublin, Ohio).(Acquisitions)(Brief Article)
June 1, 2004... Microtek Medical Holdings (Microtek; Columbus, Mississippi) said that its newly formed Netherlands-based subsidiary, Microtek Medical BV, has acquired International Medical Products BV (IMP) and its affiliates, from Cardinal Health (Dublin,...

PDSHeart (West Palm Beach, Florida), a company focused on the delivery of cardiac telemedicine, has acquired the cardiac event, Holter and pacemaker monitoring business of TransMedEx (Long Island, New York).(Acquisitions)(Brief Article)
June 1, 2004... PDSHeart (West Palm Beach, Florida), a company focused on the delivery of cardiac telemedicine, has acquired the cardiac event, Holter and pacemaker monitoring business of TransMedEx (Long Island, New York). Terms of the purchase were not...

St. Jude Medical (St. Paul, Minnesota) said it completed its previously reported acquisition of Epicor Medical (Sunnyvale, California), a developer of high-intensity focused ultrasound (HIFU) devices for the surgical ablation of cardiac tissue.(Acquisitions)(Brief Article)
June 1, 2004... St. Jude Medical (St. Paul, Minnesota) said it completed its previously reported acquisition of Epicor Medical (Sunnyvale, California), a developer of high-intensity focused ultrasound (HIFU) devices for the surgical ablation of cardiac tissue....

In conjunction with Optical Sensors' (Minneapolis, Minnesota) recent name change to Vasamed, the company acquired a proprietary impedance cardiography (ICG) technology for non-invasive cardiac output (NICO) monitoring.(Acquisitions)(Brief Article)
June 1, 2004... In conjunction with Optical Sensors' (Minneapolis, Minnesota) recent name change to Vasamed, the company acquired a proprietary impedance cardiography (ICG) technology for non-invasive cardiac output (NICO) monitoring. Paulita LaPlante,...

Boston Sci buy adds to neurostimulation.(Business Developments)
June 1, 2004... Continuing its growth beyond its core arena of interventional cardiology, Boston Scientific (Natick, Massachusetts) early this month said it would buy neurostimulation specialist Advanced Bionics (Valencia, California), through the purchase of...

Endocardial Solutions (ESI; St. Paul, Minnesota) reached an agreement with the Mayo Foundation for Medical Education and Research (Rochester, Minnesota) for the development and license of an automated 3-D cardiac segmentation and modeling software product.(Agreements)(Brief Article)
June 1, 2004... Endocardial Solutions (ESI; St. Paul, Minnesota) reached an agreement with the Mayo Foundation for Medical Education and Research (Rochester, Minnesota) for the development and license of an automated 3-D cardiac segmentation and modeling...

Endologix (Irvine, California) has signed an agreement with Edwards Lifesciences (Irvine, California) for Edwards to distribute the Endologix PowerLink System in selected European markets, including Belgium, France, Germany and the UK.(Agreements)(Brief Article)
June 1, 2004... Endologix (Irvine, California) has signed an agreement with Edwards Lifesciences (Irvine, California) for Edwards to distribute file Endologix PowerLink System in selected European markets, including Belgium, France, Germany and the UK. The...

International Medical Innovations (IMI; Toronto, Ontario), a developer of predictive medicine products, together with its wholly owned Swiss subsidiary, unveiled an exclusive worldwide non-Canadian licensing agreement with McNeil Consumer Healthcare (Guelph, Ontario), a Johnson & Johnson (New Brunswick, New Jersey) company, for IMI's non-invasive cardiovascular risk assessment technology.(Agreements)(Brief Article)
June 1, 2004... International Medical Innovations (IMI; Toronto, Ontario), a developer of predictive medicine products, together with its wholly owned Swiss subsidiary, unveiled an exclusive worldwide non-Canadian licensing agreement with McNeil Consumer...

Lifestream Technologies (Post Falls, Idaho), a developer and marketer of consumer cholesterol monitors and professional screening instruments, said that Walgreens (Deerfield, Illinois) has agreed to distribute the Lifestream Cholesterol Monitor at its more than 4,400 retail locations nationwide.(Agreements)(Brief Article)
June 1, 2004... Lifestream Technologies (Post Falls, Idaho), a developer and marketer of consumer cholesterol monitors and professional screening instruments, said that Walgreens (Deerfield, Illinois) has agreed to distribute the Lifestream Cholesterol Monitor...

Royal Philips Electronics (Amsterdam, the Netherlands) and the National Volunteer Fire Council (NVFC; Washington), a non-profit membership association representing the interests of volunteer fire, EMS and rescue services, unveiled an exclusive.(Agreements)(Brief Article)
June 1, 2004... Royal Philips Electronics (Amsterdam, the Netherlands) and the National Volunteer Fire Council (NVFC; Washington), a non-profit membership association representing the interests of volunteer fire, EMS and rescue services, unveiled an exclusive,...

Task force eyes faster product development.(Market Updates)
June 1, 2004... The Department of Health and Human Services (HHS) reported last month that it will form a multi-department task force charged with speeding the development of medical technology. The task force will involve the FDA, the Centers for Disease...

MedCath.(Personnel File)(Brief Article)
June 1, 2004... Grant Wicklund has joined MedCath (Charlotte, North Carolina) as senior vice president and chief administrative officer. Wicklund, who will be responsible for human resources, managed care, materials management/purchasing, administration and...

Medtronic.(Personnel File)(Brief Article)
June 1, 2004... Medtronic (Minneapolis, Minnesota) has appointed William Hawkins president and chief operating officer. Hawkins joined the company in January 2002 as senior vice president and president of Medtronic's vascular business and currently serves as a...

FrostByte system is cleared by FDA.(Product Pipeline)
June 1, 2004... CryoCath Technologies (Montreal, Quebec) received 510(k) regulatory clearance from the FDA in May for FrostByte, a clamp ablation device to be used in the treatment of cardiac arrhythmias. The company said it expected to receive CE mark...

AGA Medical.(Product Pipeline)(Brief Article)
June 1, 2004... AGA Medical (Minneapolis, Minnesota) ha received FDA clearance for its Amplatzer Vascula Plug, an implantable device that provides physician with a minimally invasive alternative to current options for correcting common vascular disorders. The...

AngioDynamics (Queensbury, New York), a wholly owned subsidiary of E-Z-EM, reported the release of the Mariner angiographic catheter, a hydrophilic-coated angiographic catheter designed to deliver contrast media to anatomy that is difficult to reach.(Product Pipeline)(Brief Article)
June 1, 2004... AngioDynamics (Queensbury, New York), a wholly owned subsidiary of E-Z-EM, reported the release of the Mariner angiographic catheter, a hydrophilic-coated angiographic catheter designed to deliver contrast media to anatomy that is difficult to...

Angiolink.(Product Pipeline)(Brief Article)
June 1, 2004... Angiolink (Taunton, Massachusetts) said it has filed a premarket approval (PMA) application with the FDA for its EVS vascular closure system. The private company, which is developing wound management and interventional cardiology products, said...

Boston Scientific.(Product Pipeline)(Brief Article)
June 1, 2004... Boston Scientific (Natick, Massachusetts) reported that it has completed enrollment in ARRIVE, a peri-approval registry. ARRIVE was designed to collect and analyze "real world" clinical outcomes data for the Taxus Express2 paclitaxel-eluting...

Cardima (Fremont, California) said doctors at Lenox Hill Hospital (New York) reported two successful less-invasive cases using the company's Surgical Ablation System (SAS) to treat atrial fibrillation.(Product Pipeline)(Brief Article)
June 1, 2004... Cardima (Fremont, California) said doctors at Lenox Hill Hospital (New York) reported two successful less-invasive cases using the company's Surgical Ablation System (SAS) to treat atrial fibrillation. Cardima's SAS ablates cardiac tissue...

CardioTech International (Wilmington, Massachusetts) reported that the first publication of data from human studies using the Gish Biocompatible Surface (GBS) heparin coating developed by its subsidiary, Gish Biomedical (Rancho Santa Margarita, California), was presented at the Mechanisms of Perfusion meeting in Orlando, Florida.(Product Pipeline)(Brief Article)
June 1, 2004... CardioTech International (Wilmington, Massachusetts) reported that the first publication of data from human studies using the Gish Biocompatible Surface (GBS) heparin coating developed by its subsidiary, Gish Biomedical (Rancho Santa Margarita,...

CoreValve SA.(Product Pipeline)(Brief Article)
June 1, 2004... CoreValve SA (Paris) said it is seeking Institutional Review Board approval from two undisclosed medical institutions related to its proprietary self-expanding stented heart valve, to be implanted in a human using the CoreValve Percutaneous...

Daxor.(Product Pipeline)(Brief Article)
June 1, 2004... Daxor (New York) reported a new study involving blood volume measurement and the survival of congestive heart failure patients in The American Journal of Cardiology. Daxor's semi-automated BVA100 Blood Volume Analyzer was used to measure the...

Endologix (Irvine, California) reported details of its U.S. pivotal trial with the PowerLink system endoluminal stent graft (ELG) for the minimally invasive treatment of abdominal aortic aneurysms.(Product Pipeline)(Brief Article)
June 1, 2004... Endologix (Irvine, California) reported details of its U.S. pivotal trial with the PowerLink system endoluminal stent graft (ELG) for the minimally invasive treatment of abdominal aortic aneurysms. Results of the trial were presented at the...

ev3.(Product Pipeline)(Brief Article)
June 1, 2004... ev3 (Plymouth, Minnesota) said it has received CE mark approval for the Protege GPS Nitinol Self-Expanding Stent for use during carotid stenting procedures, which are minimally invasive procedures to open blockages in carotid arteries and...

Medtronic.(Product Pipeline)(Brief Article)
June 1, 2004... Medtronic (Minneapolis, Minnesota) reported the European market release of the high-energy Intrinsic implantable cardioverter defibrillator, the first ICD with Managed Ventricular Pacing (MVP). MVP is a new pacing mode designed to promote...

Myocor.(Product Pipeline)(Brief Article)
June 1, 2004... Myocor (Minneapolis, Minnesota) reported that the U.S. Patent and Trademark Office has issued the company patent No. 6,723,038, titled "Methods and devices for improving mitral valve function." The patent covers methods for improving heart...

OmniSonics Medical Technologies.(Product Pipeline)(Brief Article)
June 1, 2004... OmniSonics Medical Technologies (Wilmington, Massachusetts) reported that it has been granted two U.S. patents relating to its OmniWave Technology Platform. Patent No. 6,730,048, titled "Apparatus and method for ultrasonic medical device with...

Orbus Medical Technologies.(Product Pipeline)(Brief Article)
June 1, 2004... Orbus Medical Technologies (Fort Lauderdale, Florida) said it has concluded its Direct Stenting Study with the Orbus R stent (DIRECTOR) trial to angiographically evaluate the performance of the R stent when implanted using the direct stenting...

Possis Medical.(Product Pipeline)(Brief Article)
June 1, 2004... Possis Medical (Minneapolis, Minnesota) reported that it has received FDA approval to market the rapid exchange version of its XMI Rheolytic Thrombectomy Catheter, the XMI-RX, for coronary indications. The XMI-RX had previously been labeled for...

Rubicon Medical (Salt Lake City, Utah) reported that the major adverse cardiac event (MACE) rate 30 days following the procedures involving 33 initial patients enrolled in its RULE-SVG study of the Rubicon Filter in Europe was 3%.(Product Pipeline)(Brief Article)
June 1, 2004... Rubicon Medical (Salt Lake City, Utah) reported that the major adverse cardiac event (MACE) rate 30 days following the procedures involving 33 initial patients enrolled in its RULE-SVG study of the Rubicon Filter in Europe was 3%. The RULE-SVG...

Spectranetics (Colorado Springs, Colorado) reported the first successful CLiRpath procedures using new Extreme Excimer Laser Catheters, recently cleared by the FDA, performed by Craig Walker, MD, Mohammed Khan, MD, and David Allie, MD, at Cardiovascular Institute of the South (Houma, Louisiana) and by John Laird, MD, at the Washington Hospital Center (Washington).(Product Pipeline)(Brief Article)
June 1, 2004... Spectranetics (Colorado Springs, Colorado) reported the first successful CLiRpath procedures using new Extreme Excimer Laser Catheters, recently cleared by the FDA, performed by Craig Walker, MD, Mohammed Khan, MD, and David Allie, MD, at...

St. Jude Medical.(Product Pipeline)(Brief Article)
June 1, 2004... St. Jude Medical (St. Paul, Minnesota) reported FDA approval of the Riata i lead family, which the company called "the world's thinnest integrated bipolar implantable cardioverter defibrillator leads." The isodiametric body diameter of Riata i...

Thoratec.(Product Pipeline)(Brief Article)
June 1, 2004... Thoratec (Pleasanton, California) reported the expansion of the Phase I feasibility trial for the HeartMate II left ventricular assist system (LVAS). The HeartMate II is a next-generation heart assist device designed to provide long-term...

Toshiba America Medical Systems.(Product Pipeline)(Brief Article)
June 1, 2004... Toshiba America Medical Systems (TAMS; Tustin, California) said a research study in the April issue of Investigative Radiology showed its SureCardio multisegment reconstruction applications to be clinically superior to standard halfscan...

W. L. Gore & Associates.(Product Pipeline)(Brief Article)
June 1, 2004... W. L. Gore & Associates (Flagstaff, Arizona) reported the addition of collagen-coated polyester vascular prostheses and vascular patches to its medical products offering. The Gore polyester product family includes collagen-coated knitted and...

WorldHeart (Ottawa, Ontario) said last month that it received conditional approval from the FDA to proceed with full enrollment of recipients in the RELIANT (Randomized Evaluation of the Novacor LVAS In A Non-Transplant Population) trial.(Product Pipeline)(Brief Article)
June 1, 2004... WorldHeart (Ottawa, Ontario) said last month that it received conditional approval from the FDA to proceed with full enrollment of recipients in the RELIANT (Randomized Evaluation of the Novacor LVAS In A Non-Transplant Population) trial. The...

Zoll Medical (Chelmsford, Massachusetts) unveiled CodeNet, a software system that allows hospital teams to better document, manage and review cardiac arrest event and resuscitation information, at the American Association of Critical Care Nurses' National Teaching Institute in Orlando, Florida, last month.(Product Pipeline)(Brief Article)
June 1, 2004... Zoll Medical (Chelmsford, Massachusetts) unveiled CodeNet, a software system that allows hospital teams to better document, manage and review cardiac arrest event and resuscitation information, at the American Association of Critical Care...