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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Following reimbursement approval in Germany, BioVentrix is making headway in long-neglected post-heart attack treatments.
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.