Leading medical devices maker CR Bard 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).
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 popliteal arteries.
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 the field. Medtronic, Inc. (MDT - Free Report) has already submitted its foremost PMA module to the FDA for its IN.PACT Admiral drug-eluting balloon.
Covidien plc , 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 investigational phase.
CR Bard presently has a Zacks Rank #3 (Hold). However, Align Technology (ALGN - Free Report) is a better-ranked stock than BCR in the medical/dental supplies industry, carrying a Zacks Rank #1 (Strong Buy).