In a bid to strengthen its endovascular portfolio, medical
) submitted its foremost pre-market approval (PMA) module to the
U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral
drug-eluting balloon. This is in line with Medtronic's plan to
submit the first module of the PMA to support the regulatory
approval in a timely manner.
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This is a significant landmark as the device is a major clinical
advancement for the treatment of peripheral artery diseases
(PAD). The IN.PACT Admiral drug-eluting balloon is a unique
peripheral angioplasty device that will be used to treat
atherosclerotic lesions in the superficial femoral artery (SFA).
The range of IN.PACT drug-eluting balloons are available in
several countries outside the U.S. since it won the CE mark way
back in 2008 and 2009. In the U.S., IN.PACT Admiral drug-eluting
balloon is not yet commercially available. It is limited for
investigational purposes under an investigational device
exemption (IDE) granted by the FDA.
As per management, the company continues to work for the timely
launch of the IN.PACT Admiral drug-eluting balloon in the U.S.
Medtronic expects to launch the device (yet to gain FDA approval)
in the second half of 2015.
Medtronic expects to serve a vast market for IN.PACT Admiral
drug-eluting balloon in the U.S. following the launch in the
second half of 2015. PAD constricts the supply of oxygenated
blood to the body, mainly the limbs as it obstructs the blood
vessels. Major risk factors contributing to PAD are obesity,
smoking, diabetes, high blood pressure, high cholesterol old age
(over 50 years) and familial history.
According to a publication from medical journal
, the incidence of PAD has increased approximately 24% over the
last decade i.e., from 164 million cases in 2000 to 202 million
reported cases in 2010 worldwide. Thus, the commercialization of
the drug-eluting balloon should expand Medtronic's addressable
We also look forward to the expected launch of other lucrative
Endovascular products like Endurant II in Japan in the ongoing
However, headwinds such as macroeconomic weakness, slower sales
recovery cycle, segment pressure and currency headwinds warrant
caution. Currently, Medtronic carries a Zacks Rank #3 (Hold).
While we have a neutral stance on the medical device major, other
stocks such as
) are worth considering. These stocks carry Zacks Rank #1 (Strong