FDA Go-Ahead For Sentinel TAVR Filter Could Drive Procedure Volumes, Firm Says
Claret Medical plans to start rolling out the TAVR accessory immediately at clinical trial centers, with full market release expected in 2018. The company is also trying to get a Medicare add-on payment.
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Boston Scientific has inked a deal of up to $270m for embolic protection system developer Claret Medical, marking its second acquisition in the space of two weeks.
Medicare Bonus Payments: CMS Plans To End Three, But Considers Seven New-Tech Add-On Payments For FY 2019
While the US Medicare agency is proposing to end hospital inpatient new-technology add-on payments for Edwards Lifesciences’ and LivaNova’s minimally surgical valves, and for WL Gore's endoprosthesis aneurysm device, it is evaluating possible bonus payments for 7 more devices beginning Oct. 1.
The panelists said the agency should approve the filter, which is used to protect the brain during transcatheter aortic heart-valve replacement surgery, despite ongoing questions about its effectiveness.