World’s leading provider of heart valves and hemodynamic monitoring Edwards Lifesciences Corporation (EW) disclosed positive one-year data on Edwards Sapien XT trans-catheter 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.
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 patients.
The affirmative data from consecutively enrolled 2,688 inoperable patients at 93 centers assesses the performance of the trans-catheter 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 encouraging.
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 trans-catheter aortic valves offer the most promising opportunity in the cardiac device space for Edwards. Despite a sluggish first quarter, the company believes the trans-catheter 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 Conceptus Inc. (CPTS), CONMED Corporation (CNMD) and The Copper Companies (COO) are worth considering. These stocks carry a Zacks Rank #2 (Buy).
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