Medtronic Redesigns Trial - Analyst Blog

Leading medical devices player Medtronic (MDT) has made some changes to the trial design of its CoreValve system in the US. The company has already received conditional approval from the US Food and Drug Administration (FDA) for its revised trial design.

The CoreValve trial in the US includes two studies, carried out on two types of patient populations – one having high risk for aortic valve surgery and the other extreme-risk patients. Subsequent to changes in the trial design, patients at extreme risk will not be considered for medical management but will only receive CoreValve devices in the study. Primary endpoint of the study will include death or major stroke within 12 months.

Although the study design of the extreme risk patients has been changed, patients in the high-risk group will be randomized to receive either transcatheter aortic valve implantation (TAVI) with CoreValve or surgical aortic valve replacement (SAVR).

The revised trial will also evaluate an alternative implantation route for delivering the transcatheter valve including the subclavian approach. While transcatheter aortic valves are generally delivered through the femoral artery in the groin, an alternative route will allow patients with poor blood vessels to avail the treatment as well. Successful development of an alternative route would expand the patient population.

Medtronic plans to enroll more than 1300 patients in the trial. Last month, the first patient was implanted with CoreValve. It is estimated that about 300,000 people are diagnosed with severe aortic stenosis globally, of which one-third are unfit to undergo open-heart surgery.

Consequently, a huge potential exists in the TAVI market. However, Edwards Lifesciences (EW) is a major competitor in this segment. Subsequent to encouraging data presented in the recent past, Edwards expects to receive approval for its Sapien heart valves in the US by the end of 2011.

We are currently Neutral on Medtronic, which is also supported by the Zacks #3 Rank (Hold).

 
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