About 300,000 patients nationally suffer from degradation of the aortic heart valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. While open aortic valve replacement for stenosis is the standard of care, about 30% of patients face contraindications to open surgery, which is obviously very invasive.
As a means of addressing the needs of this population, the Food and Drug Administration this week approved revised labeling for Edwards Lifesciences‘ (Irvine, CA) SAPIEN transcatheter heart valve, which is approved for patients who face major risks from open-heart surgery. The broader use of this innovative artificial heart valve allows surgeons to insert the implant through multiple pathways without major invasive surgery.
According to the FDA’s press release:
The FDA previously approved the valve for insertion through the femoral artery (transfemoral approach), through the leg or through the lower tip of the heart (transapical approach). The new labeling removes references to specific access points now making it available for inoperable patients who need an alternate access point.
To support the labeling change, Edwards Lifesciences Corp. submitted data from the Transcatheter Valve Therapy Registry (TVTR) in the United States and THV device registries in Europe, along with data from FDA-approved clinical studies, and peer-reviewed medical journals. The TVTR data came from several thousand procedures performed on patients using an alternative access point and showed no evidence that the device performs differently or has a different benefit-risk profile based on the access point.The manufacturer will continue to use data from the TVTR to study short- and long-term patient outcomes of THV procedures using alternative access sites.
Product page: Edwards SAPIEN Transcatheter Heart Valve…
FDA press release: FDA approval expands access to artificial heart valve for inoperable patients…