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CMS Raises Concerns With New-Technology Payment Candidates

This article was originally published in The Gray Sheet

Executive Summary

Boston Scientific’s Watchman stroke device, Medtronic and Bard’s drug-coated balloons, Cardiovascular Systems atherectomy systems and two other devices each come in for criticism in the Medicare agency’s consideration of the next round of inpatient bonus payments for new technologies.

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LAA Closure Devices At The Tipping Point

Since the FDA approval of Boston Scientific Corp.'s WATCHMAN device in March, the US market for left atrial appendage closure devices has reached a tipping point. With first-to-market advantage in the US, and a four- to five-year lead on the competition in bringing a LAAC device to the US market, BSX is well positioned to gain a strong foothold in this potentially billion dollar plus market; however, several factors will dictate market adoption of these devices in the US, including reimbursement, clinical efficacy, cost and ease of use.

Boston Sci’s Watchman Stroke Device Finally Lands FDA Approval, With Favorable Labeling

Three separate FDA advisory panels examined the clinical data supporting the left-atrial appendage closure device and struggled to identify exactly which patients it benefits. But FDA has finally approved Watchman with an indication that analysts say will support meaningful market action for Boston Scientific. Reimbursement policies, however, remain a question mark.

Let The U.S. Drug-Coated Balloon Battle Begin

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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