Societies Gain FDA Go-Ahead, Medicare Coverage To Study New Access Methods For Edward’s Sapien Valve
This article was originally published in The Gray Sheet
It’s the first time Society of Thoracic Surgeons and American College of Cardiology have ever filed for an investigational device exemption. The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.
You may also be interested in...
Medtronic’s CoreValve Makes Strides In Japan And U.S.
The Japanese regulatory authority has approved Medtronic’s CoreValve transcatheter aortic valve based on data from the CoreValve Japan trial and U.S. trial data. Meanwhile, FDA granted CoreValve its first TAVR approval for a "valve-in-valve" indication for patients with prior replacements.
TAVR Registry Data Triggers Expansion Of FDA-Approved Indication
FDA has changed the indication for transcatheter aortic valves to include any access approach for inoperable patients. The new indication, based largely on registry data, is significant due to the “message that FDA is sending in that they are looking at ways of post-market surveillance,” said surgeon Michael Mack.
Edwards Finds Transcatheter Valve Adoption In U.S. Slower Than Expected
Edwards Lifesciences is lowering its revenue expectations for 2013 based on adoption rates so far of its transcatheter aortic valve implant technology.