Let The U.S. Drug-Coated Balloon Battle Begin
This article was originally published in The Gray Sheet
Medtronic gained FDA approval for its drug-coated balloon for the peripheral artery, as expected, and it is now gunning to take share from first-to-market C.R. Bard with the help of impressive clinical data and a formidable Covidien peripheral vascular device sales force.
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Drug-coated balloon (DCBs) catheters have become the latest weapon in the fight against peripheral artery disease in the US, although they have been in use in Europe for some time. While the number of procedures employing DCBs is still dwarfed by conventional angioplasty procedures, they are expected to grow at a much faster rate, fueling a market projected to reach $1 billion by 2020; meanwhile other procedures such as mechanical atherectomy are also expected to show significant growth.
Product announcements from LivaNova, Smith & Nephew, Medtronic, Boston Scientific and Animas.
The positive hospital inpatient reimbursement decision for recently launched Medtronic and CR Bard peripheral artery devices follows prior positive policy rulings in the outpatient setting. Meanwhile, CMS rejected Boston Scientific's new-technology add-on application for the Watchman stroke device, but the agency did establish a pricier payment category for the new procedure.