SAN DIEGO, June 26 /PRNewswire/ -- REVA Medical, Inc. today announced enrollment of the first patients in a first-in-man clinical trial designed to evaluate the safety of the REVA Bioresorbable Coronary Stent for the treatment of coronary artery disease. The RESORB (REVA Endovascular Study of a Bioresorbable Coronary Stent) trial will enroll up to 30 patients at multiple sites in Germany and Brazil. RESORB is a non-randomized study with an initial assessment of major adverse cardiac events (MACE) at 30 days and a follow-up period of five years. A second trial is planned to study the safety of the REVA Paclitaxel-Coated Bioresorbable Stent in an additional 30 patients.
Principal investigator, Dr. Eberhard Grube, of the HELIOS Heart Center Siegburg, Germany, performed the first implants. "Bioresorbable stents offer great promise for the future treatment of cardiovascular disease," said Dr. Grube. "They may be an ideal solution to recent concerns regarding incomplete healing and late-stage thrombosis in stent patients."
The REVA Stent is intended to act as a temporary scaffold to support the vessel during the healing process. Once the vessel has healed, the stent is designed to resorb, leaving the patient free of a permanent implant. In preclinical studies, REVA's unique stent geometry and proprietary polymer have demonstrated mechanical performance similar to metal stents and sustained biocompatibility.
"From the beginning, REVA took a truly innovative approach to developing a fully bioresorbable stent," said Dr. Robert Schultz, REVA's President. "We've applied novel design and biomaterials solutions to create what we believe is a significant advancement in bioresorbable stent technology."
In 2004, REVA established a strategic relationship with Boston Scientific Corporation , a worldwide developer and marketer of interventional medical devices.
"We are pleased that REVA has reached the important milestone of enrolling patients in its first-in-man clinical trial," said Hank Kucheman, President of Boston Scientific's Interventional Cardiology Group. "We look forward to seeing the results of this trial and to learning more about the potential of this bioresorbable stent technology."
REVA Medical is dedicated to developing interventional medical devices that leverage the Company's novel stent designs and biomaterial technologies to improve the treatment of vascular disease. For more information, please visit http://www.teamreva.com/.
