Leading medical devices player,
) has progressed with respect to its CoreValve US pivotal trial.
The company has completed the enrollment of high-risk patients in
the trial. More than 1,500 patients have been enrolled with severe
aortic stenosis in two studies - high or extreme risk - for aortic
valve surgery. Approximately two-thirds of the patients enrolled
are in the high risk study. Enrollment of extreme risk patients is
currently ongoing as part of the Continued Access Policy of the US
Food and Drug Administration ('FDA).
Medtronic also received conditional approval from the FDA to
study the CoreValve System in patients at intermediate risk for
open-heart aortic valve replacement. Intermediate risk patients
represent huge potential as estimates put the patient size in this
category at almost double compared to the existing patient
population that has been studied so far in the pivotal study.
Patient enrollment in the US is expected to begin shortly as
part of the SURTAVI (CoreValve
mplantation) trial. Within the SURTAVI Trial, CoreValve
implantation can be performed by transfemoral, subclavian or direct
aortic access, depending on the needs of the patient.
Since 2007, the CoreValve System has been implanted in more than
30,000 people in more than 60 countries outside the US. Medtronic
is expecting approval of the system in the US in fiscal 2015.
Besides, the company is working on getting the device approved in
We are encouraged by Medtronic's focus on portfolio expansion
along with its aim to boost revenues from emerging markets.
Although the company is progressing with its CoreValve program in
) has the first mover advantage in the region with its Sapien
transcatheter heart valve. Moreover, both Medtronic and Edwards are
vying to increase their respective market share in
Meanwhile, Medtronic continues to target returning 50% of free
cash flow to shareholders. However, unfavorable currency and
macroeconomic uncertainties in Southern Europe adversely affected
sales during the recently reported first quarter. These headwinds
have also adversely affected the company's peers including
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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