FDA Approves Edwards Lifesciences’ Sapien 3 Valve for Expanded Indication
On June 5, 2017, Edwards Lifesciences (EW) received FDA approval for its Sapien 3 transcatheter heart valve (or THV) for aortic and mitral valve-in-valve procedures. It is the first transcatheter heart valve to be approved for the replacement of bioprosthetic valve in high-risk aortic and mitral patients.
However, competition has intensified in the artificial heart valve market. Edwards Lifesciences’ peers Medtronic (MDT), Boston Scientific (BSX), and Abbott Laboratories (ABT) are not far behind and seek higher market share through technological advancement and new product launches.
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The chart above illustrates Edwards Lifesciences’ opportunities and growth plans for its THV segment. Investors can gain diversified access to Edwards Lifesciences stock by investing in the Vanguard Total Stock Market ETF (VTI), which holds ~0.10% of its total portfolio in EW.
In 2015, Sapien 3 was approved for the treatment of ssAs (severe, symptomatic aortic stenosis) patients at high risk of open-heart surgery. In 2016, the device received FDA approval for the treatment of intermediate-risk ssAs patients.
Expanded indication provides safer treatment alternative
The latest indication expansion of Sapien 3 was based on study data collected by the ST/ACC1 TVT (Transcatheter Valve Therapy) Registry. The data consisted of aortic valve-in-valve procedures performed on 314 patients and mitral valve-in-valve procedures performed on 311 patients.
The FDA noted that as shown in the data registry, more than 85% of patients experienced a clinically meaningful improvement in their heart failure symptoms 30 days after the procedure. For repeat surgery, the study reported substantially lower death rates than the expected mortality rate.
According to Larry L. Wood, Edwards Lifesciences’ corporate vice president of transcatheter heart valves, “Expansion of the SAPIEN 3 device indication to include valve-in-valve procedures is a meaningful advancement for patients at high risk of an additional open-heart valve procedure, particularly for those in need of a safe alternative for mitral valve replacement.”
- Society of Thoracic Surgeons and American College of Cardiology ↩