The Centers for Medicare and Medicaid Services (CMS) said today it wants to give Medicare patients better access to cutting-edge medical devices, and that it’s willing to pay more for them beginning in fiscal year 2020. In its proposed rule, CMS said it might pay more for “certain transformative new devices” for inpatients through a […]
Boston Scientific closes $270m Claret Medical buy
Boston Scientific (NYSE:BSX) said yesterday that it closed the $270 million buyout of Claret Medical and its Sentinel device, including a $50 million earnout pegged to a reimbursement win that just came in. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. The deal, announced […]
Boston Scientific puts $270m on the table for Claret Medical
Boston Scientific (NYSE:BSX) said today that it agreed to pay as much as $270 million to acquire Claret Medical and its Sentinel device. Marlborough, Mass.-based Boston Scientific said the deal involves an up-front cash payment of $220 million and another $50 million pegged to a reimbursement milestone. Claret’s Sentinel device is designed to trap and remove […]
Report: Extra insights, but no clear-cut answers from TAVR embolic protection studies
Data from two new studies has provided extra insights, but no clear-cut solution for predicting stroke and which patients should receive embolic protection devices during transcatheter aortic valve replacement procedures, according to a new Medscape report. Results from a meta-analysis of 1,285 patients indicated that the use of embolic protection devices during TAVR procedures did […]
Claret Medical raises $21m to support Sentinel system
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted last week. In a press release posted today, the company said that it raised $14.5 million in a Series C round led by Lightstone Ventures and joined by Easton Capital, HealthCor Partners, Incept and Sante Ventures. […]
Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates. The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said. […]
Claret Medical raises $11m
Claret Medical has raised $11.2 million in a new round of equity financing, according to an SEC filing posted this week. Money in the round came from 34 unnamed investors, according to the SEC filing, with the 1st sale dated on June 22. Claret Medical is still looking to raise an additional $6.5 million in […]
MassDevice Q&A: Claret Medical’s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause […]
Claret Medical wins de novo FDA nod for Sentinel TAVR filter
Claret Medical said today that the FDA granted de novo clearance for its Sentinel device, which is designed to trap blood clots before they reach the brain during heart valve replacement procedures. The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic […]
FDA panel supports Claret Medical’s Sentinel, despite efficacy questions
UPDATED Feb. 27, 2017, with reaction from Claret Medical. The FDA’s Circulatory System Devices Panel this week gave its support to de novo clearance for Claret Medical’s Sentinel embolic protection device despite weak efficacy data for the device. The Santa Rosa, Calif.-based company’s Sentinel device is designed to use a pair of temporary arterial filters during […]
Claret Medical wins a date with the FDA for Sentinel TAVR device
An FDA advisory panel is slated to review next month the Sentinel embolic protection device made by Claret Medical, following the company’s bid for de novo clearance last fall. The federal watchdog’s Circulatory System Devices Panel scheduled a hearing for Feb. 23 to review the clearance bid for Sentinel, which is designed to use a pair of […]
