Shares of Edwards Lifesciences (NYSE:EW) got a boost today after researchers reported new data showing that a new approach for its Sapien heart valve improves outcomes for patients too sick for normal heart surgery.
The Sapien device is an artificial aortic valve replacement that’s usually inserted into the heart via catheter. The transapical approach implants the device directly into the heart through an incision between two ribs, at the apex of the aorta.
Data presented at the annual meeting of the Society of Thoracic Surgeons yesterday showed that patients in the transapical approach arms of a clinical trial had a much lower risk of adverse events including death.
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In the largest arm of the transapical cohort, 822 patients received the Edwards device transapically. After 30 days, the mortality rate for those patients was 8.2%, compared with 7.6% for patients treated with the transcatheter approach. The rate of stroke for the transapical arm was 2.0%, compared with 5.5% for the transcatheter arm, and the rate of death or stroke in the transapical arm was 9.9% vs. 12.0% for the transcatheter arm.
“It is encouraging that, in this much larger group of patients treated with transapical valve replacement, investigators observed a trend toward patients feeling better faster and having improved outcomes. We believe this more recent experience adds strong new support to the transapical procedure as an important option for patients who are at high-risk for surgery,” CEO Michael Mussallem said in prepared remarks.
The news sent EW shares up 5.9% today, to $82.91, as of about 2:30 p.m.
Leerink Swann analyst Miroslava Minkova waxed bullish on the stock, citing the positive transapical data, high interest in TAVR among surgeons at the STS conference, and the “overall positive TAVR ‘buzz’ at a surgeon meeting – a group that has historically been skeptical about TAVR procedures.”
“In our view, all this bodes well for EW – the TAVR market leader and sole US market player until at least the mid-2014 timeframe. We remain positive on EW shares as we think that ultimately (1) the TAVR opportunity will be large, (2) EW will be a key player, and (3) TAVR’s uptake will drive substantial profitability expansion at EW,” Minkova wrote in a research note to investors. “We would use any volatility around Sapien’s near-term uptake, regulatory and reimbursement uncertainties to accumulate EW shares.”
