Thoratec has announced it has filed the first two modules of its Pre-Market Approval to market its HeartMate II for bridge-to-transplantation (BTT).

The company says that of October 26, 2006, it had implanted a total of 416 patients in its Phase II pivotal trial for the next generation assist device, enrolling 97 patients during the past three months, including a record 48 patients in the Destination Therapy arm.

The American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR) says it will launch a new initiative on Jan. 7, 2007, to improve safety and outcomes for patients with Acute Coronary Syndrome (ACS). The initiative will combine the data collection and quality reporting features of two leading national ACS registries to create the largest and most comprehensive national cardiovascular patient database ever developed.

The first patient of the PATRIOT (Peripheral Approach To Recanalization In Occluded Totals) U.S. pivotal study has been enrolled by Dr. Naveen Sachdev from Providence St. Vincent's Hospital in Portland, Oregon. The study is designed to determine the safety and efficacy of the CROSSER 14 and CROSSER 18 Catheters by FlowCardia for CTO recanalization in the upper and lower legs.

An initial review of the premarket approval application for the ATS 3f(R) Aortic Bioprosthesis Heart Valve has been completed by The Center for Devices and Radiological Health FDA.

The ATS 3f(R) brand — by ATS Medical, Minneapolis, MN — encompasses multiple tissue heart valve product offerings at varying steps from market introductions to clinical trials to development projects that incorporate less invasive valve replacement technology.

Company chairman and president says it’s an important milestone along the path to U.S. market approval of the device.

The FDA has cleared Boston Scientific’s NexStent Carotid Stent and Monorail Delivery System for use in patients with carotid artery disease who are at high risk for surgery. The NexStent Carotid Stent is manufactured by EndoTex Interventional Systems, Inc. and has been distributed exclusively by Boston Scientific outside the U.S. since receiving European CE Mark in 2005.

Stereotaxis has received FDA 510(k) clearance for its Niobe magnetic navigation system for use in neurovascular and peripheral applications with the company's family of Cronus magnetically enabled .014" vascular guide wires. The Niobe System and Cronus guide wires were previously cleared for coronary vasculature procedures only.

The Cronus guide wire family will now integrate with the Niobe magnetic navigation system to provide precise magnetic guide wire navigation in coronary, neurovascular and peripheral anatomy, according to a company press statement.

San Francisco-based McKesson announced it has agreed to purchase Per-Se Technologies, Alpharetta, Ga., in a deal worth $1.8 billion. The purchase is expected to close in the first quarter of 2007 if it meets regulatory approval.

An aspirin a day really does keep heart attack and stroke away for women, yet fewer than half of American women who could benefit from the simple measure do not take a daily pill, according to recent research.

Washington University surgeons at Barnes-Jewish Hospital, St. Louis, began training at UMC in Tucson on Nov. 2 to become one of only nine hospitals in the U.S. certified to implant the CardioWest temporary Total Artificial Heart (TAH-t). Ranked No. 10 on the “U.S. News and World Report’s” Best Heart Hospitals of 2006, the Barnes-Jewish program has earned a reputation for taking on the most challenging cases, including patients who may have been turned down at other implant centers.

A dedicated interventional cardiology track is slated during the 2006 Scientific Sessions of the AHA in Chicago that starts this weekend. Beginning with the Pre-Sessions Symposium and running throughout the conference, the program will feature the latest scientific advancements and clinical practices in interventional cardiology.

The meeting will cover a broad array of topics tailored to interventional cardiologists, and will include late-breaking clinical trials data, the newest translational science and renowned speakers.

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