The Sapien 3 and Sapien XT transcatheter aortic valve replacements can now be used for patients with an intermediate risk of death or complications during open heart surgery. The valves — implanted via a catheter in a minimally invasive procedure — were previously only approved for high-risk patients..
The FDA based its approval on results released in April of a clinical trial involving intermediate-risk patients. Individuals who received a valve replacement via the company’s TAVR implantation system had a significantly lower death and stroke rate than those who underwent surgical implantation.
The TAVR line of products already accounts for more than half of Edwards’ revenue. Analysts expect the additional approval to increase the Irvine, Calif.-based company’s addressable market by 50 percent.
More articles on supply chain:
FDA rejects Portola’s blood thinner antidote
Hillary Clinton vows to tackle high drug costs: 3 takeaways
Drug giants enter bidding war for cancer drugmaker Medivation
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.