Insufficient Evidence on Safety & Effectiveness to achieve FDA Approval for MiItraclip
Published date : 19 March 2013
Article date : 19 March 2013
Nasdaq reports that the FDA has recommended against approving Abbott Vascular's Mitraclip heart device on the basis that they believe there is insufficient evidence to demonstrate that it is safe and effective.
The device is designed to repair heart valves in patients who are not considered to be good candidates for valve-replacement surgery.
The article says that on Monday, the FDA released a review of Mitraclip in advance of a meeting this Wednesday where an advisory committee will consider the manufacturer's application for approval. Apparently, the review recommends that the device should remain available as an investigational device so it can be used in two ongoing clinical trials where the patients are considered high-risk and inoperable.
Source: Jennifer Corbett Dooren, Dow Jones Business News, 18 March 2013.
