News | July 16, 2012

Initial Enrollment of ReZolve Bioresorbable Stent Trial Completed

Data so far shows no reported MACE

July 16, 2012 — Reva Medical Inc. announced it completed clinical enrollment with the ReZolve drug-eluting bioresorbable scaffold. A total of 26 patients have been enrolled and there are no major adverse coronary events (MACE) reported to date.

The ReZolve sirolimus-eluting bioresorbable coronary stent is a fully bioresorbable polymer device designed to provide all of the proven benefits of a metal drug-eluting stent, with the advantage of dissolving from the body when it is no longer needed, leaving the patient free of a permanent implant.

The first patient in the study was enrolled in December 2011. Reva plans to provide an update on data from these patients at the Transcatheter Cardiovascular Therapeutics (TCT) 2012 conference, which will be held in October in Miami, Fla.

Reva anticipates resumption of clinical trials in the fourth quarter of 2012, when patients will be treated with Reva's lower profile (6 French guide compatible) ReZolve2 scaffold. ReZolve2 will be evaluated at up to 25 clinical study sites in Brazil, Europe, Australia and New Zealand.

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