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.

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.

Subscribe to
© Copyright Wainscot Media. All Rights Reserved.
Subscribe Now