Edwards Lifesciences (EW), will present data from the Cohort A of the PARTNER trial at the American College of Cardiology annual conference in New Orleans in early April.
The PARTNER trial is evaluating Edwards’ Sapien transcatheter heart valve (THV) in both operable (Cohort A) and inoperable (Cohort B) patients with severe aortic stenosis.
Patients (699) under Cohort A have been randomized equally for either high risk surgery or the Sapien THV, while Cohort B patients (358) were randomized equally for medical management or the Sapien THV.
Edwards submitted a pre-market approval (PMA) application for Cohort B to the US Food and Drug Administration (FDA) in October 2010 and expects to submit a PMA for Cohort A during the second quarter of 2011. The company anticipates launching Sapien THV in the US during the fourth quarter of 2011 and expects sales of approximately $20-$25 million from Sapien.
During the fourth quarter of fiscal 2010, Heart Valve Therapy, the largest segment of Edwards, recorded sales of $226.2 million, up 20.1% compared to the year-ago period. Sales of surgical heart valves grew 4.9% to $160.9 million led by continued adoption of the Magna valve platform and Physio II rings.
THV sales increased 87.2% compared to the year-ago quarter to $65.3 million with Sapien XT making a strong contribution. Moreover, THV sales doubled on an underlying basis, which included $3-$4 million of incremental stocking orders. With the introduction of Sapien XT, Edwards witnessed a 5%-10% improvement in pricing.
The market for THV is highly competitive with Medtronic (MDT) trying to get its CoreValve approved in the US. Moreover, Boston Scientific (BSX) will also emerge as a competitor in the Percutaneous Aortic Valves segment with its decision to acquire Sadra Medical.
We have a ‘Neutral’ recommendation on Edwards, which also corresponds to a Zacks #3 Rank (hold) in the short-term.
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