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| IN.PACT Admiral drug-coated balloon--Courtesy of Medtronic |
Medtronic ($MDT) is celebrating positive study results for its drug-coated balloon device for peripheral artery disease (PAD), days after Covidien ($COV) announced that it would sell off its own drug-coated balloon to clear the way for the companies' pending merger.
Medtronic's IN.PACT SFA trial enrolled 331 subjects at 57 sites across Europe and the United States, and treated a subset of patients with diabetes and PAD with its IN.PACT Admiral drug-coated balloon or traditional balloon angioplasty. The study found that 82.2% of the patients experienced restored blood flow through the diseased artery when treated with the company's drug-coated balloon, as opposed to 52.4% in the traditional angioplasty group.
Only 2.4% of patients treated with the drug-coated balloon required a repeat procedure at 12 months, while 20.6% of patients in the control group required an additional procedure.
The results bode well for Medtronic, as the company pushes for FDA approval of its drug-coated balloon. The Minneapolis, MN-based devicemaker won a CE mark for the product in 2009, but the balloon remains an investigational medical device in the U.S. Approximately 650,000 to 700,000 people in the U.S. and Western Europe undergo an interventional procedure for PAD each year, Medtronic said in a statement, opening the door for a potentially lucrative market.
Medtronic also faces one less competitor in the space, as Covidien recently announced that it would sell its clinical-stage Stellarex drug-coated angioplasty balloon to Spectranetics ($SPNC) for $30 million. The Dublin-based devicemaker hinted that it would divest the product in an earlier filing to clear the way for its $43 billion merger with Medtronic under antitrust law.
But Medtronic is not the only company developing drug-coated balloon products. Device heavyweights like C.R. Bard ($BCR) and Boston Scientific ($BSX) are hard at work on their own drug-coated balloons, chalking up regulatory approvals and rolling out next-generation products. In July, Boston Scientific won a CE mark for its drug-coated balloon catheter for PAD, expanding its footprint in the endovascular market and continuing its push to ramp up sales.
In October, C.R. Bard won FDA premarket approval for its Lutonix 035 Drug Coated Balloon Catheter, making it the first company to score U.S. regulators' signoff for a drug-coated balloon. The device prevents the reopening of narrowed or blocked arteries in the knee or thigh of patients with PAD and is approved to treat 60% of PAD patients in the U.S., the company said in an earlier statement.
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