Dissolving drug-eluting stents were one of those devices that sounded like a great idea, but which in practice didn’t really take off. Abbott withdrew the best-known one, Absorb, in 2017 after it failed to sell, and when Reva Medical went into bankruptcy protection in early 2020 the technology was largely regarded as defunct. But it takes more than that to keep Reva down, it seems: the company is back with a $45m series B round and a new bioresorbable device for a different indication. Where formerly it was trying to treat blocked coronary arteries with a scaffold called Fantom, it is now heading to pivotal trials in below-the-knee peripheral vascular disease with a scaffold called Motiv. Motiv is made of a polymer called Tyrocore that Motiv developed itself, and leaches the antiproliferative sirolimus. Reva believes that the new cash, from “a global strategic investor with deep experience in medical devices”, as well as Biostar Capital and existing investors, will allow it to take Motiv to the FDA. Data from an uncontrolled pilot trial were encouraging, but the pivotal, versus balloon angioplasty, will be a far harder test.
|Status of selected bioresorbable scaffolds
|Pilot trial data encouraging; pivotal study to start soon
|CE marked Apr 2017; company filed for bankruptcy protection Jan 2020
|CE marked Jun 2016, device still on sale
|Meril Life Science
|CE marked Aug 2019, device still on sale
|CE marked Jan 2011; FDA approved Jul 2016; withdrawn from sale worldwide Sep 2017
|CE marked May 2013, device not mentioned on company website
|CE mark had been expected Dec 2017; company website now defunct
|CE mark had been expected in Mar 2018; company website now defunct
|Arterial Remodeling Technologies
|CE marked May 2015; company website now defunct
|*For below-the-knee peripheral vascular disease; all others for coronary arteries. Source: Evaluate Medtech & company websites.