Cardica Inc. has announced that it has received FDA 510(k) clearance to market its C-Port Flex A Anastomosis System in the U.S. The Flex A is a variation of Cardica's C-Port xA Distal Anastomosis System product line and further facilitates the automated anastomosis, or attachment of blood vessels and grafts, during less invasive coronary artery bypass graft (CABG) procedures.

April 4, 2007 — Stereotaxis, Inc. has announced that its partnered magnetically enabled 8mm ablation catheter has received FDA approval and will soon be commercially available in the U.S.

Two leading European electrophysiology centers have been building successful clinical experience using this catheter to treat atrial cardiac arrhythmias.

April 4, 2007 — Vital Images, Inc., a leading provider of enterprise-wide advanced visualization and analysis software, and Toshiba Medical Systems Corp. have agreed to renew their U.S. and international marketing and distribution agreement for two years, through December 31, 2008.

April 4, 2007 — Volcano Corp. and ev3 Inc. have announced they have entered into a joint marketing and distribution agreement.

Under the terms of the agreement, Volcano will have the opportunity to sell ev3’s SpiderFX Embolic Protection Device in conjunction with its Intravascular Ultrasound (IVUS) and Functional Measurement (FM) devices for use in saphenous vein grafts (SVGs) in the U.S. The SpiderFX is FDA cleared for use during the endovascular treatment of both SVGs and carotid arteries.

April 4, 2007 — A Japanese study has shown that people who take statins and also consume omega-3 fatty acids, typically found in fish and fish oil, have a better chance of avoiding heart problems than patients who take statins alone. The “Japan EPA Lipids Intervention Study” was published in the March 31 issue of The Lancet.

April 3, 2007 — Cardiovascular Associates, Kingsport, TN, has announced it is studying a medical device in patients to measure the potential health benefits of a new implantable pulse generator called the Optimizer. Developed by Impulse Dynamics, the Optimizer delivers electrical impulses to the heart for patients who suffer from moderate-to-severe heart failure.

April 3, 2007 — GE Healthcare and Volcano Corp. have successfully implemented, at multiple sites, Innova IVUS, the world's only fully Integrated IVUS and Cath Lab system. An exclusive collaboration between Volcano Corp. and GE Healthcare made implementation of the fully integrated intravascular ultrasound system for the cath lab and interventional suite possible.

April 3, 2007 —FoxHollow Technologies Inc. has announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for its NightHawk Plaque Excision System. The intended use of the NightHawk System is in the evaluation of peripheral vascular morphology.

April 3, 2007 — Medicare has announced it will approve additional hospitals for ventricular assist device implantations.

Under the previous Medicare regulations, approved facilities had to meet requirements outlined in a 2003 National Coverage Determination.

The updated requirements, which could open the door to certification of more facilities, include having an experienced surgeon on hand, and certification by the Joint Commission on Accreditation of Healthcare Organizations.

April 2, 2007 — Mount Sinai Medical Center, Miami Beach, FL, has implanted one of the first of a new device intended to strengthen the heartbeat of patients with heart failure. The pacemaker-like device called the Optimizer System is a pulse generator designed to deliver electrical impulses to the heart for treatment of moderate to severe heart failure.

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