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

This article was originally published in The Gray Sheet

Executive Summary

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.

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Many medtech companies reported their sales and earnings for all of 2016, along with projections for 2017, at the end of January or early February. Medtech Insight has examined their reports as well as the comments of the analysts who track these companies to highlight a few that had especially good years, some that had down years, and some lesser-known companies worth watching in the future.

CMS Proposes CED Policy For Watchman With Some Unexpected Conditions

The proposed national coverage decision for the left-atrial appendage closure stroke device would grant Medicare coverage with stipulations, including one provision that appears to contradict a key element of FDA labeling and a challenging registry requirement.

Voices From TCT 2015: Ken Stein On The Future Of Watchman

In an exclusive podcast interview with "The Gray Sheet," Ken Stein, Boston Scientific's chief medical officer for cardiac rhythm management, says the company is well positioned to expand adoption of its novel Watchman left-atrial appendage closure device after a challenging regulatory process. He says CMS' recent denial of a new-technology add-on payment is actually good news for the device and the company is looking forward to that agency establishing a national coverage policy.

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