FDA approves Epic tissue valve:
This article was originally published in Clinica
Executive Summary
The US FDA has approved St Jude Medical's PMA supplement for its Epic stented tissue valve. The product is identical to the company's Biocor Valve, which the St Paul, Minnesota-based firm claims is the fastest growing tissue valve in the US market. The Epic Valve incorporates anti-calcification technology which protects against tissue mineralisation. Around 100,000 US patients undergo heart valve replacement each year; the majority receive tissue valves. The valve will be launched in early 2008.