Covidien plc ( COV ) recently obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Fortrex over-the-wire percutaneous transluminal angioplasty (PTA) balloon catheter. Fortrex PTA balloon catheter is designed for both maintaining arteriovenous (AV) access for hemodialysis and treating peripheral artery diseases.
Hemodialysis is a procedure that filters waste and removes extra fluid from the blood in patients suffering from chronic kidney disease or end stage renal failure. AV access sites are used to provide hemodialysis to patients. However, plaque blockages at the dialysis site can limit access.
Engineered to maximize the inflation of the balloon to break up the blockages and open the vessel, Covidien's Fortrex PTA balloon provides better hemodialysis access. A high pressure solution is used to crack the short, fibrous lesions that can block AV access.
The balloon's unique material and design also provide clinicians with optimized balloon delivery, predictable and targeted treatment and procedural efficiency. The FDA clearance of this device builds on Covidien's existing PTA portfolio, providing clinicians with access to an advanced solution to improve AV access in patients being treated with hemodialysis.
Covidien's shares closed little changed at $99.32 yesterday. This Mansfield-based company has delivered a healthy return of roughly 46% so far this year.
Earlier this month, Covidien signed a deal to sell its Stellarex drug-coated angioplasty balloon (DCB) platform to Spectranetics for $30 million. Covidien decided to divest its Stellarex DCB platform so that the pending $43 billion merger with Medtronic, Inc. ( MDT ) can commence under the antitrust law.
Designed to treat peripheral arterial disease, Stellarex DCB is part of Covidien's vascular product line. An FDA sanction for this device is expected in 2017.
Covidien faces significant competition from the likes of Becton, Dickinson and Co. ( BDX ) and CR Bard Inc. ( BCR ), which is major headwind in the near term. Notably, C.R. Bard's Lutonix 035 DCB Catheter became the first drug-coated balloon to be cleared by the FDA for percutaneous transluminal angioplasty in Oct 2014.
Currently, Covidien carries a Zacks Rank #3 (Hold).
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