The recent US Food and Drug Administration ("FDA") 510(k)
clearance for Affinity Fusion oxygenation system has enhanced the
structural heart business of medical devices major -
). The company also announced the first US clinical use of this
new oxygenation system. Notably, last September, the company
gained CE Mark for this system in Europe.
According to Medtronic, this new system, which combines
several advanced features, oxygenates and removes carbon dioxide
from blood during several open-heart surgical procedures. The
company claims that these new features potentially reduce the
risk of stroke, preventing the entry of air bubbles in blood
during the surgery procedure. According to the company, this
system can be helpful for hospitals, which are focusing on
implementation of patient blood management programs and other
With a number of heart patients undergoing cardiac surgery
annually, Medtronic remains hopeful about the greater adoption of
this oxygenation system among physicians and hospitals. The
company encouragingly noted that, this year, there would be about
1 million cases of cardiopulmonary bypass worldwide. The process
has already included the collaboration between the company and
more than 500 perfusionists globally.
Medtronic's consistent expansion of its portfolio via
approvals in the domestic and international market is
encouraging. With the FDA approval for Affinity Fusion
oxygenation system, the company extended its structural heart
portfolio. Medtronic's focus on the structural heart business is
likely to deliver positive results, as substantial adoption of
newer products should leverage the top line.
According to the company, the structural heart business is a
high-focus franchise in the emerging markets, especially in
China. Notably, Medtronic's peer in the structural heart business
) is also committed to meaningful portfolio expansion.
New product launches are expected to contribute at least $200
million in fiscal 2014 for Medtronic. However, unfavorable
currency movement, tough competitive landscape and global
economic uncertainties keep us on the sidelines. The stock
carries a Zacks Rank #3 (Hold). However, other stocks in the
medical device sector, carrying a Zacks Rank #1 (Strong Buy),
Medical Action Industries Inc.
) appear impressive.
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