Reva Presents 12-Month RESTORE Data and ReZolve2 Program Update

May 21, 2013—At EuroPCR 2013 in Paris, France, Reva Medical, Inc. (San Diego, CA) released 12-month data on a subset of patients enrolled in the RESTORE clinical trial. The RESTORE trial is evaluating the safety and performance of the first-generation ReZolve sirolimus-eluting bioresorbable coronary scaffold, which was implanted in 22 patients between December 2011 and July 2012. Alexandre Abizaid, MD, is principal investigator of the study. Dr. Abizaid is also Director of Invasive Cardiology at the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil.

In an analysis of the patients who completed 12-month angiographic follow-up (8 to date, out of 22), imaging results demonstrated a mean in-stent late lumen loss of 0.2 mm, indicating very little change in the lumen area between the time of treatment when blood flow was restored and the time of follow-up. The company noted that permanent drug-eluting stents have historically exhibited late loss values in the range of 0.2 mm to 0.4 mm, which has generally corresponded to positive long-term outcomes.

Dr. Abizaid commented in the company's press release, “The 12-month late loss demonstrated to date with the ReZolve scaffold is well within the range of safety and performance of drug-eluting metal stents and bioresorbable scaffolds that are used today. This preliminary analysis is very encouraging, as it indicates that the ReZolve scaffold has the potential to successfully treat coronary artery disease, with the added benefit of resorbing from the body over time, allowing the artery to return to its natural function.”

Reva noted that since the most recent report of clinical data, which included an analysis of all patients through a 6-month follow-up, two additional patients were re-treated for focal in-stent restenosis or renarrowing of the artery at the implant site, and an additional patient died from unknown causes.

According to Reva, the ReZolve2 device is a lower-profile, sheathless version of the first-generation ReZolve scaffold that offers improved deliverability and an approximate 30% increase in scaffold strength to provide increased support to significant coronary artery lesions before being resorbed by the body. Implantation procedures with the ReZolve2 device began in March 2013. The initial three clinical sites enrolled eight patients during the first month of the study; enrollment with ReZolve2 will expand to approximately 30 clinical centers, including additional sites in Australia, Germany, and New Zealand. The company expects to enroll 125 patients with ReZolve2 by September 2013 to provide the data needed to apply for European CE Mark approval.