Reva Medical has commenced patient enrolment in a pilot study designed to investigate its ReZolve bioresorbable sirolimus-eluting coronary scaffold.
ReZolve is a fully bioresorbable polymer scaffold that provides all of the proven benefits of a metal drug-eluting stent, with the advantage of dissolving from the body after it is no longer needed, leaving the patient free of a permanent implant.
The pilot trial, RESTORE, is a prospective multicentre study intended to evaluate the safety and performance of ReZolve in 50 patients with symptomatic coronary artery disease due to one or more discrete areas of blockage. It will be conducted at leading heart centres in Brazil and Europe.
In the study, the primary endpoint is freedom from symptomatic target lesion revascularisation at a six-month clinical evaluation, and imaging of the stented area at 12 months.
Instituto Dante Pazzanese de Cardiologia in São Paulo, Brazil Coronary Interventions chief Alexandre Abizaid said that the company's fully bioresorbable polymer scaffold was well-apposed against the artery wall and able to visualise the entire scaffold under standard X-ray imaging.
"The procedure went very smoothly in a 90% occluded coronary artery utilising standard practices that are used to implant conventional metallic stents around the world today,'' Abizaid said.
"Bioresorbable scaffolds represent an exciting new frontier to the treatment of coronary artery disease due to their potential to return the vessel to normal function after restoring blood flow."
Reva chairman and CEO Bob Stockman said that Reva now joins other companies who have advanced the treatment of coronary artery disease, and will evaluate the novel and highly anticipated technology.
The company plans to initiate a larger scale clinical trial to support an application for the CE mark.