Update: June 11, 2012
The FDA briefing documents for the June 13 advisory committee to review the PARTNER-A label expansion indicate that the trial was biased by the fact that 7% of the patients randomized to open heart surgery never received surgery. Meanwhile, the stroke rate was 100% greater in the Sapien valve, and the valve function was inferior with aortic regurgitation.
July 22, 2011
Steven Greer, MD gave a 5-minute slide presentation to the July 20th FDA advisory committee that was convened to evaluate the possible approval of the new Edwards Lifesciences (EW) percutaneous aortic valve. He drew comparisons to the now infamous JNJ Cypher coronary stent, pioneered by Dr. Marty Leon and his CRF crew, and the new Edwards Sapien valve, also being led in development clinically by Dr. Leon, et al. and urged caution before approving the valve without adequate safety data.