RESTORE Results Support Bolton Medical's Relay Thoracic Stent Graft

January 31, 2011—According to Bolton Medical, Inc. (Sunrise, FL), the final results of the international RESTORE (Relay Endovascular Registry for Thoracic Disease) registry confirm the safety and efficacy of the company's Relay thoracic stent graft for treating a broad range of thoracic aortic pathologies. Principal investigator Vincent Riambau, MD, et al have published the study online ahead of print in the Journal of Vascular Surgery.

The company stated that the RESTORE study is a multicenter, European, prospective, monitored clinical registry that included 304 patients with any of the following thoracic aortic pathologies: aneurysms, dissections, pseudoaneurysms, penetrating atherosclerotic ulcers, intramural hematomas, and trauma or emergent applications. The study included patients in 20 centers in Spain, Germany, Italy, Austria, France, Greece, and the Netherlands. Patients were followed at 1-, 6-, 12-, and 24-month intervals. The entire series had an average follow-up time of 334 days.

In the RESTORE study, the Relay thoracic stent graft demonstrated a stroke rate of 1.6% within the entire population. This rate was achieved with the proximal landing zone being located in the aortic arch in 79% of cases and with enrollment including high-risk patients and patients with acute situations and difficult anatomies.

Bolton Medical also noted that the rate of endoleak of any type was 4.6%, and there were no intraoperative conversions to open procedures. In 80% of cases, only one stent graft was required for complete treatment, which minimized the risk of disconnection, time of intervention, fluoroscopic load, and cost. The 30-day mortality rate was 7.2%. Survival rates at 12 and 24 months were 97.3% and 95.9%, respectively.

“The results of RESTORE support the safety of thoracic endovascular aortic repair with the Relay stent graft, even in acute and complicated situations,” commented Dr. Riambau. “The device was highly efficient in angulated aortic anatomies, with acceptable mortality and a low rate of neurologic complications.”