Leading medical devices player, Medtronic (MDT), has enrolled the first patient in the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial. The randomized clinical trial aims to compare the CoreValve system with surgical aortic valve replacement (“SAVR”) in patients with severe aortic stenosis who are at intermediate risk to undergo open-heart surgery.
The trial plans to evaluate approximately 2,500 patients at up to 75 clinical sites that are equipped with experienced heart teams encompassing interventional cardiologists and cardiac surgeons. The patients will be randomized equally to undergo either surgery or implantation of CoreValve, through one of the following procedures – transfemoral, subclavian or direct aortic access – depending on the requirements.
It will assess whether the CoreValve system is non-inferior to SAVR based on data on all-cause mortality and major stroke at 24 months. The company is also working with the US Food and Drug Administration (“FDA”) to include US patients in the trial. All patients will be followed through five years.
Medtronic’s CoreValve system received CE Mark in 2007, making it the only transcatheter aortic valve implantation system approved for implantation via the direct aortic approach and the subclavian approach. The device is yet to be approved in the US.
The company had earlier announced completion of enrollment in the extreme risk arm of the US pivotal study of CoreValve. Besides, the study for the high-risk arm was scheduled to be over by the summer of 2012. Successful development of the system for the intermediate risk patients will be of immense benefit to a considerably large patient population.
Acknowledging the challenges at play in its core segments, Medtronic is in the process of launching several new products in promising areas that are likely to drive growth in this difficult scenario. Many of the recently launched products are contributing significantly to the top line. Besides, the company is increasing its focus on the emerging markets. Such a strategy is also being followed by its peers Boston Scientific (BSX) and St Jude Medical (STJ).
We have a Neutral recommendation on Medtronic. The stock retains a Zacks #3 Rank (Hold) in the short term.
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