Leading medical devices player,
), 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
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
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
St Jude Medical
We have a Neutral recommendation on Medtronic. The stock retains
a Zacks #3 Rank (Hold) in the short term.
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