Boston Scientific wins CE mark for next-generation drug-coated balloon catheter

Boston Scientific's Ranger DCB catheter--Courtesy of Boston Scientific

Boston Scientific ($BSX) won a CE mark for its next-generation drug-coated balloon (DCB) catheter for peripheral artery disease (PAD), expanding its presence in the endovascular market and continuing its push to reinvigorate sales.

The company's Ranger DCB product incorporates Sterling balloon technology and is coated with paclitaxel, an antistenotic drug that treats diseased vascular tissue without leaving behind a permanent implant. An estimated 12% to 14% of the general population is affected by PAD, and Boston Scientific's device treats below- and above-the-knee lesions while optimizing drug delivery, the company said in a statement. Boston Scientific is currently launching the product in Europe.

"This latest innovation in drug and coating technology is another example of our commitment to advancing the care of patients worldwide. We are pleased to add a state-of-the-art drug-coated balloon to our leading portfolio of peripheral solutions," Jeff Mirviss, president of Peripheral Interventions, said in a statement.

The regulatory blessing bodes well for Boston Scientific, which continues to counter slumping sales and a tough reimbursement economy with new product offerings. The company recently acquired Bayer AG's interventional division for $415 million to beef up its peripheral vascular disease offerings, adding Bayer's AngioJet Thromectomy System, the Fetch 2 Aspiration Catheter and the JetStream Atherectomy System to its portfolio as part of the transaction.

New device approvals also help Boston Scientific compete in a saturated market, as archrivals Medtronic ($MDT) and C.R. Bard ($BCR) are moving forward with their own drug-eluting balloons products. In June, Medtronic submitted final data to the FDA for its IN.PACT Admiral drug-coated balloon, just ahead of the first agency panel review for competitor C.R. Bard's device. The company sees the drug-eluting market as worth $600 million by fiscal year 2018, and hopes to win approval for its product by May or June 2015, Cardiac & Vascular Group President Michael Coyle said at a recent analyst event.

- read the release

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