The British Standards Institute has given CE Marking to Ventracor for its VentrAssist left ventricular assist device (LVAD), allowing the company to market and sell the device throughout Europe.

Ventracor CEO Peter Crosby stated that his company will continue its drive to develop strong clinical data published in reputable scientific journals by key opinion leaders, which is essential to build market acceptance that will drive future sales.

The Washington Post reports that while people with implanted cardioverter defibrillators (ICDs) or pacemakers do reap life-saving benefits from shocks to their hearts, these individuals also face unwanted and disturbing jolts when other injury or terminal illness brings them to life’s end. The article by Rob Stein says that the implants can make the act of dying harder, forcing terminally ill patients and families to make wrenching decisions about turning them off.

The Healthcare Information and Management Systems Society (HIMSS) will put its healthcare IT mission into action as the organization heads to New Orleans for its 2007 Annual HIMSS Conference & Exhibition Feb 25 to March 1 by partnering with the Common Ground Health Clinic in the Katrina-ravaged city.

Two Illinois medical centers are now ready to use the TandemHeart PTVA System from CardiacAssist: Northwestern Memorial Hospital in Chicago and Sherman Hospital in Elgin have joined the more than 75 hospitals nationally and more than 90 centers worldwide using the TandemHeart System for extracorporeal circulatory support. The TandemHeart System is used in 17 of the top 20 heart and heart surgery hospitals in the U.S. and 11 of the nation's top 14 hospitals overall.

The FDA has given CoAxia Inc. approval to move forward on a safety and feasibility study for the NeuroFlo perfusion augmentation therapy in ischemic stroke patients who present for treatment as late as 24 hours after stroke onset. Perhaps the first interventional device trial approved for this patient population, the study will enroll up to 25 patients and the results will determine future expansion to a pivotal study in late presenting stroke patients.

The FDA medical devices dispute resolution panel that met on Dec. 15 voted 3 to 1 to uphold a previous FDA decision that did not approve the CorCap cardiac support device. The agency says the heart device needs more study.

Acorn Cardiovascular Inc. disagreed with the FDA and said it had provided enough information to support a reasonable assurance of safety and effectiveness of its implantable mesh bag designed to support the blood-pumping muscle of patients with heart failure.

Diagnostic & Invasive Cardiology editor Kim Phelan spoke with Jeff Mirviss, vice president of Stent Marketing at Boston Scientific to get a first-hand perspective and highlights from the FDA panel that reviewed the safety of drug-eluting stents on Dec. 7 and 8. Following are excerpts from that phone interview Dec. 12.

Outline what you consider to be the key highlights from the two-day meeting.

The embolic protection system Boston Scientific Corp. originally designed for coronary saphenous vein graft interventions has received FDA clearance for use in carotid artery stenting procedures. FilterWire EZ was approved in August 2004 for the SVG indication and, the company says, it is the current market-leading embolic protection device for carotid stenting outside the U.S.

Medtronic was honored at a ceremony this week that recognizes the best and brightest technology innovators in Minnesota. In the category of Medical Technology — Devices, Diagnostics and Equipment, the 2006 Tekne Awards selected the Medtronic for its Chronicle(R) ICD, a first-of-its-kind implantable heart failure device that can transmit a patients’ information from their home to their physicians via a standard phone line.

A new study, released today by the Society for Cardiovascular Angiography and Interventions, shows that the minimally invasive technique of carotid stenting has made a successful transfer from the academic environment where it was created into the hands of real-world physicians who have received proper education and training.

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