Boston Scientific closes acquisition of Claret Medical

Boston Scientific Corporation has recently closed its acquisition of Claret Medical, Inc., a privately-held company that has developed and commercialized the Sentinel Cerebral Embolic Protection System, the only device cleared to protect patients against the risk of stroke in transcatheter aortic valve replacement (TAVR) procedures. The company also announced that the US centers for medicare and medicaid services (CMS) granted a new technology add-on payment (NTAP) designation for the Sentinel System as part of the federal fiscal year 2019 inpatient prospective payment system (IPPS). The NTAP designation, awarded to new medical devices determined to substantially improve the diagnosis or treatment of Medicare beneficiaries, will be effective on October 1, 2018.

The Sentinel System – which received the CE Mark in 2014 and FDA clearance in 2017 – is the only commercially available device used to protect patients against the risk of stroke during TAVR, a minimally–invasive procedure to replace the aortic valve in patients with severe aortic stenosis. Embolic debris such as calcium or tissue can break loose during the procedure, travel through the bloodstream toward the brain, and potentially cause neurological and neurocognitive damage. Recent studies have estimated approximately 4 percent of patients experience a clinically-apparent stroke within 30 days of a TAVR procedure. The landmark Sentinel trial, which led to regulatory clearance, demonstrated that the Sentinel System reduced the incidence of strokes by 63 percent within the first 72 hours of the procedure.

Boston Scientific announced a definitive agreement to acquire Claret Medical on July 20, 2018 for USD 220 million in up-front cash with an additional USD 50 million payment for reaching a reimbursement-based milestone, which has been fulfilled with the recent NTAP designation.