Edwards Lifesciences (EW) recently presented positive data on 2,300 patients enrolled in the post-market European SOURCE Registry. It was observed that the clinicians achieved success after one-year in patients (deemed unfit for surgery) treated with the Sapien valve. Data obtained from the patients since November 2007 were presented at EuroPCR 2011.
Although the mortality rate was high in many of these patients, survival rates remained at the higher side – 76% in the 1,038 patients treated under Cohort I (after 1 year of commercialization) and 77% in 1,269 patients treated in Cohort II (after second year).
During the first quarter of fiscal 2011, Heart Valve Therapy recorded sales of $244.9 million, up 24.5% compared to the year-ago period. Sales of surgical heart valves grew 9.2% to $172.2 million (one of the strongest quarters in recent times) led by continued adoption of the Magna family of valves.
Transcatheter heart valve (THV) sales increased 85.7% compared to the year-ago quarter to $72.7 million driven by expanding sales of Sapien XT in Europe, coupled with $2−$3 million of incremental stocking orders of the new 29 mm Sapien XT valve. During the reported quarter, the company saw transfemoral sales triple over the year-ago period while sales of the new 29 mm valve lifted transapical sales by almost 40% year over year. The company also received CE Mark approval for E-sheath, an expandable sheath technology, to be used for Sapien XT with NovaFlex (transfemoral) delivery system. The company launched the product, which can reduce vascular complications, at EuroPCR 2011.
Although Edwards has witnessed strong growth in the THV based on the successful launch of Sapien products in Europe, the product is yet to receive approval in the US. However, the company expects to launch Sapien THV in the US during the fourth quarter of 2011 and expects sales of approximately $20-$25 million. Following its potential approval in the US, Edwards will try to receive reimbursement for the product. Approval of the device in the US or Japan should boost revenues of the company in the long term.
We have a Neutral rating on Medtronic, which also corresponds to the Zacks #3 Rank (Hold) for the short term.
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