LimFlow On Target For 2021 US Launch Of Deep Vein Arterialization System
The results from the PROMISE I feasibility study give LimFlow confidence that the PROMISE II pivotal trial will prove that the LimFlow percutaneous deep vein arterialization system is a safe and effective alternative to amputation for patients with critical limb ischemia.
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R&D Roundup, November 2019: LimFlow Starts Pivotal Trial Of Peripheral Shunt; Conservative Coronary Treatment Matches Intervention In Trial
An overview of November’s 10 most-read Medtech Insight articles on topics related to research and development of new medical technology.
As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.
The US Medicare agency revised and clarified its policies on how it evaluates new technology add-on payments and highlighted its new policy on payments for FDA-approved breakthrough devices, in a final 2020 Inpatient Prospective Payment System (IPPS) rule released on 5 August.