The American College of Cardiology (ACC) participated in a meeting on July 20 of the Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting regarding pre-market approval of Edwards Lifesciences SAPIEN Transcatheter Heart Valve. This is one of several devices in development for use in the emerging field of transcatheter valve therapy (TVT).
TVT has been documented by the PARTNER trial to improve outcomes in patients with severe aortic stenosis who are inoperable. It has been found to significantly reduce mortality and composite endpoints at one year compared to medical therapy, including balloon aortic valvuloplasty. A recent societal overview on TVT issued by the ACC and the Society of Thoracic Surgons (STS) underscored the need for collaboration between government, industry and medical societies as this new therapy moves forward.
During the public comment portion of the meeting, ACC President David R. Holmes, Jr., MD, FACC, provided well-received comments on behalf of the ACC that highlighted the issues outlined in the societal overview. He also stressed the benefits of using clinical data repositories like the NCDR® to document and optimize outcomes in patients, as well as identify areas that need to be changed or improved going forward.
Leaders from STS and The Society for Cardiovascular Angiography and Interventions (SCAI) also provided testimony. The STS testimony from President Michael Mack, MD, FACC, can be viewed here. The ACC has been working closely with STS, SCAI and others to align efforts to ensure the physician community is prepared to appropriately use the technology.
Following the hearing, the Advisory Committee voted on three main questions:
1) In a vote of 7-3, the committee agreed there was "reasonable assurance that the Edwards SAPIEN™ Transcatheter Heart Valve is safe for use in patients with severe aortic stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis." 2) In a vote of 9-1, the committee said there is "reasonable assurance that the Edwards SAPIEN™ Transcatheter Heart Valve is effective for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication."
3) In a vote of 9-0-1, the committee said the "benefits of the Edwards SAPIEN™ Transcatheter Heart Valve for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication outweigh the risks of the Edwards SAPIEN™ Transcatheter Heart Valve for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication."
It is now up to the FDA to make a final decision. More information will be posted here as it become available, including video coverage and blog discussions. Read the ACC's complete written testimony now.