Endologix touts 5-year pivotal data on Ovation stent graft
Dr. Manish Mehta of New York’s Vascular Health Partners of Community Care Physicians, principal investigator in the Ovation study, said the data showed broad applicability, with 40% of patients treated off-label from other EVAR devices. The Ovation-treated patients stable neck diameters, with average expansion of 0.1% compared to 25% as reported with other EVAR devices, Endologix said. The study showed a 97.5% rate of freedom from secondary interventions for Type 1 endoleaks and no migration or conversions, the company said.
“The 5-year data from the Ovation pivotal trial confirm the long-term safety and durability of the Ovation system. The study included the broadest range of AAA patients ever treated in an endovascular AAA IDE trial, and demonstrates the effectiveness of Ovation system’s ultra-low profile delivery system and polymer sealing technology,” Mehta said in prepared remarks.
“Completion of the 5-year follow-up is an important milestone that validates the long-term durability of EVAR with the Ovation system. It also demonstrates the capability that the Ovation system enables physicians to treat more AAA patients than other devices. We would like to thank Dr. Mehta and all of the investigators for their participation in the clinical trial and congratulate them for their outstanding results,” added CEO John McDermott.