Start-Up Spotlight: BioVentrix Expects Revivent TC Heart Failure Device To Succeed Where Others Failed
Two-year data from a European trial showed BioVentrix’s Revivent TC system significantly reduces left-ventricular volume and improves left-ventricular function in patients with heart failure following a myocardial infarction. The company expects to complete a US pivotal trial of the device in 2021 and launch the device in the US with funding from a planned initial public offering.
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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.
BioVentrix Inc. is developing a unique, minimally invasive approach to reshaping the heart’s scarred and enlarged left ventricle aimed at patients who develop ischemic heart failure following a heart attack. The company has made considerable headway with its technology, which offers an interesting balance between a catheter-based and surgical-based procedure; however, CEO Kenneth Miller, well aware of the pitfalls that have plagued earlier companies in this field, is taking a cautious approach to the US market.
Device Week, 17 January 2020 – FDA's Amy Abernethy Describes Medtech's Future; Researchers Want More Oversight Of Robotic Surgery
In this edition of Device Week, Medtech Insight's Marion Webb discusses her experiences at the recent Consumer Electronics Show in Las Vegas, including her interview with Amy Abernethy, who is the US Food and Drug Administration's principal deputy commissioner. Deputy editor Reed Miller discusses a recent study from the University of Michigan that suggests the growth of robotic-assisted surgery may be outpacing the evidence to support that technology.