Novel Bioresorbable Coronary Stent Begins Clinical Evaluation
June 27, 2007 — REVA Medical, Inc. recently 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 in 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.
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.
In 2004, REVA established a strategic relationship with Boston Scientific Corporation a worldwide developer and marketer of interventional medical devices.
For more information: www.teamreva.com