TriVascular of Santa Rosa, California announced receiving FDA approval to bring to market its Ovation Prime Abdominal Stent Graft System. This is an upgrade to the Ovation stent system that received a Humanitarian Device Exemption (HDE) in the U.S. two years ago.
Used for minimally invasive treatment of abdominal aortic aneurysms (AAA), the Ovation Prime, just like it’s older cousin, is delivered via 14 French catheter but has improved delivery characteristics. It features polymer-filled sealing ring technology for improved stability in placement.
Delivered through a 14 French (4.7 mm) outer diameter catheter, Ovation Prime is the lowest profile commercially available system for endovascular aortic repair (EVAR).
Ovation Prime utilizes innovative polymer-filled sealing ring technology and has the broadest indications for use (IFU) of any endovascular graft, thereby expanding the pool of patients eligible for EVAR.
Ovation Prime was developed in close collaboration with a global network of endovascular specialists. The new delivery system is designed to simplify device preparation, enhance deliverability, increase visualization, and facilitate optimized orientation and cannulation, all while maintaining the excellent implant performance of Ovation.
The Ovation IDE pivotal study included 36 sites from the U.S., Germany and Chile, with a total of 161 patients treated. There were no device related major adverse events, no aneurysm ruptures, and no conversions from EVAR to open surgical repair reported in the study. An independent imaging core laboratory reported 0% type I and type III endoleaks and 0% migration. Nearly 40% of patients treated had complex anatomies, with proximal neck lengths shorter than 10 mm, distal access vessels smaller than 6 mm, or both. The method of vessel access was left to the discretion of the physician, with 43% of patients treated percutaneously. Worldwide, over 1,300 patients have been treated with Ovation.
Product page: Ovation Prime Abdominal Stent Graft System…