World's leading provider of heart valves and hemodynamic
Edwards Lifesciences Corporation
) disclosed positive one-year data on Edwards Sapien XT
transcatheter aortic heart valve from the post-approval study in
Europe. The company presented the data from the SOURCE XT
Registry at the EuroPCR 2013 in Paris.
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The SOURCE XT Registry is evaluating the performance of Edwards
Sapien XT on high-risk and inoperable patients with acute,
symptomatic aortic stenosis in an actual commercial setting. The
patients were enrolled between Jul 2012 and Oct 2012 and will be
monitored closely over five years.
The one-year outcome from this monitored and adjudicated
prospective registry from 17 nations across Europe depicts the
clinical efficacy of the company's Sapien XT with improved
patient outcomes. According to the data from EuroPCR,
Edwards Sapien XT has immense potential as it eliminates
procedural complications and leads to fewer vascular events in
The affirmative data from consecutively enrolled 2,688 inoperable
patients at 93 centers assesses the performance of the
transcatheter aortic valve replacement (TAVR). This reflects over
20% of the total number of patients treated with Edwards Sapien
XT during the time period of the post-approval study.
The data from Europe demonstrates the clinical benefits of the
company's lower-profile Sapien XT valve. The positive patient
outcomes on Sapien XT from actual and clinical trial settings are
Other Updates on Sapien XT
While data from Europe continues to demonstrate the clinical
competency of the Sapien XT valve, the valve is yet to be
launched in the U.S. Edwards continues to enroll patients in the
intermediate risk cohort (Cohort A) of The Partner II Trial in
the U.S. The enrollment is expected to round off by mid-2013.
With plans to submit Cohort B clinical results from The Partner
II Trial for the U.S. Food and Drug Administration (FDA) approval
shortly, Edwards envisages the U.S. approval to come through in
2014. The company also expects regulatory approval and
reimbursement in Japan for Sapien XT in the ongoing year.
We believe that the transcatheter aortic valves offer the most
promising opportunity in the cardiac device space for Edwards.
Despite a sluggish first quarter, the company believes the
transcatheter heart valve (THV) product group remains the revenue
driver and is expected to do well in the upcoming quarters. We
also believe that the THV segment of the company has the
potential to lead sales and earnings over the long haul.
With a dismal start to 2013 when Edwards' revenues and earnings
missed the Zacks Consensus Estimate and considerable guidance
cut, the estimate revision trend also reflects a bearish tone
towards the stock. As a result, the stock carries a Zacks Rank #4
(Sell). While we prefer to avoid Edwards, we believe that other
medical stock such as
The Copper Companies
) are worth considering. These stocks carry a Zacks Rank #2