REVA Medical has received approval from the German health authority BfArM to commence the RESTORE clinical trial, which evaluates the safety of ReZolve Bioresorbable Coronary Stent.
ReZolve stent combines REVA’s proprietary stent design with a proprietary polymer that is metabolised and cleared from the body.
The ReZolve stent is designed to offer full x-ray visibility, clinically relevant sizing and a controlled and safe resorption rate.
In addition, by early encapsulation of the stent in the artery tissue coupled with the loss of stent structure over time, the ReZolve stent reduces the incidence of late forming blood clots, or thrombosis.
REVA is in the process of finalising the design of its ReZolve stent and currently intends to initiate a pilot human clinical trial in the third quarter of 2011.
The trial will initially enroll patients in multiple centers in Brazil and Germany.
Approval was also granted by the Brazilian Ministry of Health, CONEP, earlier this month.