News In Brief

A nationwide registry to collect data on transcatheter aortic heart valve replacements was launched Dec. 1 by the Society of Thoracic Surgeons and the American College of Cardiology. The two groups jointly developed the tool, dubbed the “TVT Registry,” to track real-world outcomes with the procedure in conjunction with FDA’s first-of-a-kind approval last month of Edwards Lifesciences’ Sapien valve. Edwards will employ the registry to meet certain post-market study requirements tied to the FDA approval, which targets use of the device in patients who are too sick, frail or high risk for conventional open-heart valve surgery. It is also highly likely that CMS will require hospitals to enter patient data in the registry as a condition of Medicare coverage once it finalizes a pending national coverage determination for the procedure. (See Also see "CMS Jumps Out Ahead Of FDA With Transcatheter Valve Coverage Analysis" - Medtech Insight, 3 October, 2011..) STS and ACC say the TVT Registry will be linked to the Social Security Death Master File and Medicare databases to track long-term outcomes. In addition, hospitals participating in the registry will receive quarterly reports comparing an institution’s procedure performance with national outcomes.

Molecular diagnostics and life sciences product maker plans to save about $50 million annually beginning in 2012 by streamlining its organizational structure and cutting its workforce of 3,800 by about...