Following years of anticipation, the U.S. Food and Drug Administration (FDA) has approved Edward Lifesciences’ transcatheter aortic valve implantation (TAVI) device, the SAPIEN valve, for patients ineligible for traditional aortic valve surgery replacement. While the device has been in use in Europe since 2007, this is a first of its kind technology in the U.S. This announcement arrives not long after CMS’ initiation of a national coverage analysis for TAVI in late September, effectively beginning the process to determine Medicare beneficiary coverage eligibility for the device.
As reported by our Technology Insights colleague Ashley Ford, SAPIEN’s approval comes on the heels of a July FDA panel where the SAPIEN received a positive recommendation for approval. Based on one-year data from Cohort B of the pivotal PARTNER trial, TAVI demonstrated improvements in overall mortality. Cohort B, one of the two trial arms, randomized inoperable patients to therapy with TAVI or standard therapy such as balloon valvuloplasty.
These data were reviewed during the FDA panel, which stipulated that the device be approved for non-surgical candidates only. Cohort A, which randomized high-risk surgical patients to TAVI or surgical replacement, published its one-year data at ACC in April and therefore was not included in the original panel. Additional labeling to expand TAVI approval to high-risk patients will only come after a second FDA panel in the future.
During the FDA panel review, many concerns regarding commercial approval were discussed. Hot topics included physician credentialing, side effects such as stoke and vascular complications and, most notably, patient selection and the concept of “risk creep.” Presently, TAVI is positioned as a “hybrid” procedure requiring both surgical and interventional expertise for device delivery. It is no surprise that the product label included an advisement that a heart surgeon be involved in determining whether the SAPIEN transcatheter heart valve (THV) is a suitable treatment for a patient.
SAPIEN’s approval comes just days before the annual Transcatheter Therapeutics (TCT) Conference, to be held next week in San Francisco. As the largest interventional cardiology conference in the U.S., significant attention is devoted to transcatheter valves. With two full days of scientific symposia devoted to transcatheter aortic and mitral valves, as well as four late-breaking trial presentations on Thursday, SAPIEN’s approval comes at an exciting time for TAVI and for TCT.
The Cardiovascular Roundtable has been keeping a close watch on developments surrounding this game-changing technology, releasing a briefing on transcatheter valve technology earlier this fall detailing the latest volume forecasts, expected reimbursement figures, and key program elements for centers evaluating TAVI and other transcatheter-based therapies. Furthermore, the Roundtable’s latest publication, Heart and Vascular Service Line Integration, provides detailed best practices for developing an integrated, multidisciplinary care model that not only supports the use of transcatheter-based therapies, but also provides a foundation for future growth and prosperity.