Interventional cardiology devices developer Medinol has completed enrollment of patients in its Bionics trial, which has been designed to assess the safety and effectiveness of a new eDES coronary stent system.
The company has enrolled around 1,918 patients in the multicenter Bionics trial in the US, EU, Canada and Israel.
The trial is a 1:1 randomized study, which is comparing the eDES system to Medtronic’s Resolute Integrity Stent System.
According to the firm, the primary endpoint of the study is target lesion failure (TLF) as determined at 12 months.
Bionics trial principal investigator Dr David Kandzari said: "The design of eDES enhances stent deliverability and conformability for the treatment of complex coronary disease."
Trial results will be used to obtain approval from the US Food and Drug Administration (FDA) for the elastomeric drug eluting stent to treat patients with narrowing or blockage of their coronary arteries.
Medinol’s eDES is coated with an elastomer, which maintains a smooth and uniform stent surface designed to prevent the cracking or peeling that may occur with brittle polymers.
The stent comprises cobalt chromium and a limus family drug that is intended to prevent restenosis. It is manufactured and coated in flat panels using the firm’s patented QualitySurface technology.
Medinol CEO Dr Judith Richter said: "We believe that our innovative eDES will offer a significant advancement in patient treatment options based on stent and elastomer coating design improvements and overall deliverability."
The eDES system is an investigational device and not yet approved for commercial sale.