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Wednesday, January 18, 2012

REVA : the RESTORE Clinical Trial First Human Implants With ReZolve(TM) Scaffold

REVA Medical
Dec. 21, 2011 - REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company") is pleased to announce that it has initiated patient enrollment in a pilot clinical study designed to evaluate its ReZolve™ Bioresorbable Sirolimus-Eluting Coronary Scaffold. The RESTORE Trial (Pilot Study of the ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold) will evaluate the safety and performance of ReZolve in 50 patients at multiple leading heart centers in Brazil and Europe.

ReZolve is a fully bioresorbable polymer scaffold designed to provide 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 first patient implant was performed by the study's principal investigator, Dr. Alexandre Abizaid, Chief of Coronary Interventions at the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil. Dr. Abizaid is a renowned interventional cardiologist and the institute is one of the world's leading heart centers.

"The procedure went very smoothly in a 90% occluded coronary artery utilizing standard practices that are used to implant conventional metallic stents around the world today. The REVA fully bioresorbable polymer scaffold deployed and became well-apposed against the artery wall and we were able to visualize the entire scaffold under standard x-ray imaging, which was very helpful," commented Dr. Abizaid. "While we will need to continue to gather data over the coming year to measure the safety and efficacy of this device, I was pleased with the outcome of today's procedure; the ReZolve scaffold delivered and deployed as designed." Dr. Abizaid also added, "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. I am excited about the potential clinical benefits ReZolve may provide our patients and my team looks forward to enrolling additional patients in the RESTORE trial."... [PDF] REVA Medical's Press Release -