Global leader in heart valves and hemodynamic monitoring – Edwards Lifesciences Corporation (EW) – disclosed positive five-year data from the PARTNER trial, reflecting benefits of Sapien valves in patients unable to undergo an open heart surgery.
These long-term results from the PARTNER trial, a randomized trial for transcatheter aortic valve replacement (TAVR) in inoperable patients, were published at the 26th Transcatheter Cardiovascular Therapeutics (TCT) of the Cardiovascular Research Foundation. According to Edwards, the trial outcome showed TAVR as associated with a continued significant mortality benefit, consistent symptom benefit and significant reduction in rehospitalizations.
According to the company, the PARTNER Trial has played an important role so far in the development of TAVR as well as the significance of Edwards’ Sapien valves for inoperable aortic stenosis (AS) patients. Earlier, one- and two-year results from the PARTNER trial were published in The New England Journal of Medicine. In Cohort B of this trial, inoperable patients with severe, symptomatic AS were evenly randomized to receive either transfemoral TAVR with the Sapien valve or standard therapy, which included balloon aortic valvuloplasty or medical management of symptoms.
We are encouraged by Edwards’ focus on building its pipeline that should further strengthen its foothold across all its operating businesses. In Transcatheter Heart Valves (THV), enrollment of 1,000 intermediate risk patients in the U.S. SAPIEN 3 trial is on track, and is expected to be completed by the end of 2014. The company also reported completion of enrollment in the high-risk and inoperable patient arm, FDA approval for which is expected in 2016.
In the meantime, Edwards is gaining experience with Centera, the commercial launch of which in Europe is expected this year. Further, at the EuroPCR meeting in May, the company presented data on its early experience with Sapien 3 which demonstrated a notable reduction in PV Leak – an important complication. Successful commercialization of these products should drive the company’s top line in the long term.
The stock currently carries a Zacks Rank #2 (Buy). Some well-ranked medical product stocks worth considering are Alphatec Holdings, Inc. (ATEC), ERBA Diagnostics, Inc. (ERB) and RTI Surgical Inc. (RTIX). All the three stocks sport a Zacks Rank #1 (Strong Buy).
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