Edwards Lifesciences Corporation (EW) received the U.S. Food and Drug Administration (FDA) approval for its Edwards SAPIEN XT transcatheter aortic heart valve. The valve finds use in treatment of severe symptomatic aortic stenosis (AS) patients, who are at high risk of surgery but need replacement of their surgical mitral or aortic valve.
The heart valve comes in three sizes – 23 mm, 26 mm and 29mm, with the last one better suited for treating patients with a large native annulus. Management believes that with the FDA approval now in its kitty, the Edwards SAPIEN XT valve will facilitate physicians to treat a greater number of patients.
The Edwards SAPIEN XT valve will be immediately available to patients at leading cardiovascular centers across the U.S., along with the NovaFlex+ transfemoral delivery system. This delivery system can be administered through a low-profile 16-French expandable sheath (eSheath) and the Ascendra+ transapical and transaortic delivery systems.
According to reliable sources, positive clinical outcomes of randomized studies have been observed in both high-risk and inoperable patients, who have chosen SAPIEN XT as their treatment option.
Edwards Lifesciences had been studying patients with AS under the Partner II trial in the U.S. to evaluate the safety and efficacy of this next generation heart valve. The study results revealed reduced complications and improved outcomes in inoperable patients treated with the transcatheter aortic valve replacement (TAVR) procedure using the SAPIEN XT valve.
So far, the SAPIEN family of valves has been used in the treatment of more than 70,000 patients across the globe – with the majority of them treated with SAPIEN XT. The Edwards SAPIEN XT valve has been commercially available in Europe since 2010, and has also received regulatory and reimbursement approval in Japan in 2013.
Moreover, earlier in 2014, Edwards Lifesciences became the only company in Europe to receive CE Mark for valve-in-valve procedures using the SAPIEN XT valve, providing minimally invasive treatment options to patients in need of surgical mitral or aortic valve replacement.
Edwards Lifesciences currently has a Zacks Rank #3 (Hold). Some better-ranked stocks worth considering in the medical instruments industry include Alphatec Holdings, Inc. (ATEC), Luminex Corporation (LMNX) and RTI Surgical Inc. (RTIX). All these stocks carry a Zacks Rank #1 (Strong Buy).
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