Physicians at the Center of Cardiac Surgery Erlangen-Nuremberg at Friedrich Alexander Hospital have initiated a new training and certification program for implanting the CardioWest temporary Total Artificial Heart (TAH-t). Led by Prof. Michael Weyand, M.D., cardiac surgeon, Dr. Tandler, and members of the heart transplant team at the center, the training is a four-part certification process that includes the proctored implant of the center's first CardioWest TAH-t today, Dec. 14, 2006.

Possis Medical, Inc. has closed a $2.5 million equity investment in Rafael Medical Technologies, Inc., which gives Possis 15 percent ownership in Rafael Medical and a three-year option to purchase the company.

Volcano Corp., Stanford University, Cardialysis and the Cardiovascular Research Foundation in which Volcano will provide IVUS catheters free of charge for use in pivotal drug-eluting stent (DES) clinical trials. The offer will be made available to stent manufacturers utilizing the core lab services of Stanford, Cardialysis or CRF in trials where IVUS images and data are planned to be collected in 100 percent of patients at enrollment and at pre-determined follow-up periods.

Cardiac Science has begun shipping its news Powerheart G3 Plus, a CPR-enhanced addition to the Powerheart automated external defibrillator platform designed for the public access defibrillation market in the U.S. and abroad.

The FDA will convene a Medical Device Dispute Resolution Panel (MDDRP) on Dec. 15 to consider the first device to specifically treat enlarged hearts and potentially reduce heart failure progression. Acorn Cardiovascular’s CorCap cardiac support device is a mesh wrap that is placed around the heart to provide support of the muscle and reduce ventricular enlargement. More than 465 patients worldwide have received the new treatment.

MicroMed Cardiovascular, Inc. has received a CE Mark extension to continue marketing its DeBakey VAD system in Europe for another five years. The new, extended European Union CE Mark is valid until April 27, 2011.

The approval results from a rigorous scientific review of the technology and its accessories from both a design/manufacturing/quality perspective as well as a comprehensive review of all of the commercially implanted patient experience gained since the original CE Mark certification on April 27, 2001 for its approved Indications For Use.

The Laboratory Services unit of Rheologics has launched a Whole Blood Viscosity (WBV) testing program for physicians. The company specializes in facilitating the study of blood viscosity and its relationship to cardiovascular disease.

The FDA panel that convened for an intense, two-day review of drug-eluting stents last week heard key testimony from clinical experts at both Boston Scientific Corp. and Cordis Corp., the only two interventional device manufacturers in the U.S. that have FDA clearance to market the devices. The panel concluded that, for on-label indications, DES appear to increase the risk of late stent thrombosis but do not increase the risk of death or MI.

A strong grassroots effort among physicians played a key role in staving off a Medicare physician payment cut that would have taken effect Jan. 1, 2007. Over the weekend, the House and Senate voted to eliminate the impending 5 percent payment slash — the legislation provides a zero percent update for 2007, as well as a 1.5 percent incentive payment to physicians who report on quality measures beginning July 1, 2007 through Dec. 31, 2007.

The FDA panel that is re-evaluating the safety of drug-eluting stents convenes Dec. 7 and 8 at the Hilton Washington DC North in Gaithersburg, MD.

The Circulatory System Devices Panel has a full agenda of hearing public and corporate presentations related to the late thrombosis connection with DES. Specifically, the panel is commissioned to address the following questions, according to an FDA Web page:

Questions to the Panel

Circulatory System Devices Panel December 7 and 8, 2006 On-Label Use of DES

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