Who's Next? Emerging LAA Closure Devices
As first-to-market in the US with a transcatheter left atrial appendage closure device, Boston Scientific has blazed a regulatory and reimbursement trail for other companies in this space and opened up a potentially billion-dollar-plus market. In this second part of our two-part series on LAAC devices, Medtech Insight reports on other companies with current and emerging LAAC devices and looks at how close they are to bringing their technology to the US market.
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J&J's Biosense Webster heart-rhythm device unit has acquired privately held partner Coherex Medical, solidifying its stake in the left atrial appendage closure market that Boston Scientific currently leads.
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.
Updates include an FDA safety communication for the Lariat suture device addressing use for left atrial appendage closure, new FDA draft guidance documents, and CMS proposals to cut radiation therapy payments and launch new payment models for hip and knee replacements.