November 2006 Issues

Transcatheter Cardiovascular Therapeutics (TCT) Part I -- Drug-Eluting Stents

Summary: U.S. DES usage is likely to go down – and perhaps substantially. Cardiac surgeons, medical cardiologists, and reporters are not going to drop the late stent thrombosis issue, personal injury attorneys are starting to discover it, and patients are concerned. ♦ The FDA may consider DES label changes, but no recall of drug-eluting stents is likely. The Circulatory Systems Advisory Committee meeting on December 7-8, 2006 , will focus on labeling, post-marketing studies, and the definition of stent thrombosis. But it will also give DES critics a forum and increase publicity about patient deaths. ♦ Experts believe the cause of stent thrombosis is multifactorial, but in the longer term the issue may drive interest in, and acceptance of, bioabsorbable stents. ♦ The everolimus-eluting Vision stent (Abbott’s Xience V/Boston Scientific’s Promus) is expected to capture significant market share quickly when approved in the U.S. , but will hospitals buy it from Abbott or Boston Scientific? The decision is likely to be up to hospital purchasing agents, not cardiologists.

Centers for Medicare & Medicaid Services (CMS) Issues New Rules -- Quick Pulse

Summary: On November 1, 2006 , CMS Acting Administrator Leslie Norwalk and Acting Deputy Administrator Herb Kuhn announced several new Medicare rules being implemented. Norwalk said the measures are designed to provide “higher quality, increased transparency, personalized care, and accurate payments.”

LASIK Update -- Quick Pulse

Summary: As a preview to the American Academy of Ophthalmology (AAO) meeting in Las Vegas this weekend, 12 refractive surgeons were interviewed about trends in refractive surgery.