Leading medical devices maker
) achieved a milestone by submitting the final pre-market
approval (PMA) module to the U.S. Food and Drug Administration
(FDA) for its Lutonix Drug-Coated PTA Dilatation Catheter (DCB).
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This new technology, which combines the advantages of angioplasty
balloons and drug-releasing stents, is used for the treatment of
peripheral arterial disease in superficial femoral (SFA) and
Bard acquired Lutonix in Dec 2011. Lutonix DCB is available for
sale in Europe and some other nations. In the U.S., the company
is conducting a pivotal Levant 2 investigational device exemption
(IDE) clinical trial comparing the Lutonix drug-coated balloon to
standard balloon angioplasty.
The Levant 2 study is the first IDE trial approved by the FDA. It
analyzed 476 patients with diseased femoropopliteal leg arteries
across 55 medical centers globally. Data from Levant 2 along with
Levant 1 and the Levant Continued Access Safety Registry have
been submitted to the FDA regulatory panel.
Approval of the Lutonix balloons from the FDA will be a
significant achievement for BCR's vascular products portfolio.
The market opportunity for this new technology is huge.
Demand for the novel drug-coated balloons have been increasing
among doctors as this advanced technology is capable of treating
diseased arteries without the requirement of a permanent implant.
As per independent research, it is forecasted that the global
peripheral vascular market for this technology might exceed $1
billion annually over the next decade.
However, we are aware of stiff competition from other players in
) has already submitted its foremost PMA module to the FDA for
its IN.PACT Admiral drug-eluting balloon.
), another medical technologies giant, acquired CV Ingenuity in
Jan 2013 to access its key product - a DCB platform with a unique
tunable rapid-release system. The product is still in the
CR Bard presently has a Zacks Rank #3 (Hold). However,
) is a better-ranked stock than BCR in the medical/dental
supplies industry, carrying a Zacks Rank #1 (Strong Buy).