MINNEAPOLIS, MN — With a clear eye toward its competition's unenviable position, Boston Scientific has decided to stop development of its bioabsorbable vascular scaffold, Renuvia.
The decision to halt the Renuvia program comes in the wake of accumulating negative data for Abbott Vascular's first-generation bioabsorbable scaffold, Absorb BVS.
In March, the FDA issued an alert cautioning physicians about its use in smaller coronary vessels after data showed a significant increase in major adverse cardiac events vs Abbott's everolimus-eluting metal stent (Xience).
A new meta-analysis also shows poorer 2-year outcomes with Absorb BVS than with Xience, including significantly higher risks for target-vessel MI (relative risk 1.68) and scaffold thrombosis (RR 3.35).
"First-generation bioresorbable stents [BRS], like Abbott's Absorb, have demonstrated poor acute performance and increased safety concerns, limiting their use in real-world clinical settings and ultimately resulting in a market that is developing more slowly than previously expected," Boston Scientific spokesperson Timette Nevala told theheart.org | Medscape Cardiology in an email.
In addition to the FDA investigation in the US, she noted that the demonstrated higher safety risks with Absorb has resulted in severe use limitations in Europe, Japan, Australia, and other countries.
"While our Renuvia bioresorbable scaffold is a second-generation technology designed to overcome many of the limitations of first-generation BRS, pursuing commercialization of that product is not a primary focus for us at this time," Nevala said.
"In order to make the greatest impact to patients and clinicians, we are focusing our efforts on next-generation enhancements to our [drug-eluting stent] portfolio."
Boston Scientific, however, is expected to present Renuvia early feasibility data at TCT 2017 in October in Denver.
The data are reportedly promising, but in a report by the Minneapolis-St Paul Star Tribune, Boston Scientific's global chief medical officer Dr Ian Meredith notes that these early patients had relatively simple medical histories.
"You have to ask the question, do we actually put the effort into studying this in much more complex patients, many of whom are at higher risk of events anyway, against a background of literature from all over the world showing consistently that this strategy is associated with worse outcomes?" he is quoted as saying. "We think it doesn't make sense to do this."
Medscape Medical News © 2017
Cite this: Boston Scientific Halts Bioabsorbable-Scaffold Program - Medscape - Aug 02, 2017.