TAVI Approval: An Alternate Perspective (7 Nov 2011)

Norman Silverman, MD

The FDA’s decision to release for general use the Sapien transcatheter aortic heart valve implantation (TAVI) technology ends the conflicting reports of either imminent approval or six months delay for further evaluation. This had created quite a stir. Self-proclaimed patient advocates aver that enough vetting has occurred and decry that excessive regulatory obstruction is denying the American public the benefits of noninvasive valve replacement. They cite the safety and hemodynamic benefits reported by many European centers. And these results have accrued in very high-risk, elderly patients who MAY (my emphasis added)… Continue Reading