Edwards Lifesciences (EW) SAPIEN 3 THV Gets FDA Approval

Medical equipment major Edwards Lifesciences Corporation EW recently announced the receipt of FDA approval for aortic and mitral valve-in-valve procedures using SAPIEN 3 transcatheter heart valve (THV). This expanded indication represents the first appr
oval for the SAPIEN 3 valve in the U.S. for bioprosthetic valve replacement in aortic and mitral patients.

Basically, SAPIEN 3 is an artificial valve which falls under Edwards Lifesciences’ THV segment. This segment includes technologies designed to treat heart valve diseases using catheter-based appr
oaches as opposed to open surgical techniques.

The latest indication expansion was based on data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry. The results displayed that patients can be safely treated with SAPIEN 3 valve for bioprosthetic mitral valve replacement through valve-in-valve procedure rather than subsequent high-risk open heart surgery.

In the above mentioned procedure, the new transcatheter valve is inserted tightly within the failed prosthetic valve, pushing the old valve leaflets aside.

To be noted, Edwards Lifescience’s SAPIEN 3 valve got FDA approval in 2015 for severe, symptomatic aortic stenosis patients at high risk for open heart surgery. In 2016, it received approval for the treatment of patients who are at intermediate risk for open-heart surgery.

Taking into consideration the huge growth potential of the THV market, the recent FDA approval for SAPIEN 3 Valve is a strategic fit. As per Persistence Market Research report, the global heart valve repair and replacement market is projected to be worth $3,767.0 million in 2020 at a CAGR of 8.7%.

Of late, Edward Lifesciences has witnessed multiple developments in its THV segment. Management released positive patient outcomes of SAPIEN 3 valve including high survival rates and low rates of stroke and paravalvular leak. In another study, Edwards Lifesciences’ CENTERA valve displayed favorable results for transcatheter aortic valve replacement (TAVR) patients.

Meanwhile, over the last one month, Edwards Lifesciences has been trading above the Zacks categorized Medical – Instruments industry. The company has gained 6.3%, compared to the 4.9% gain of the broader industry. We believe that compelling clinical evidences and regulatory approvals at the THV segment will further boost share price in the near future.

SOURCE nasdaq