TriVascular presented three-year primary safety and performance metrics from the Ovation Pivotal Trial at the 2014 Joint Annual Meeting of the New England Vascular Society and Eastern Vascular Society (11–14 September 2014, Boston, USA).
At the three-year mark, the study continued to show strong clinical results. Specifically, the data showed 100% freedom from aneurysm rupture, 100% freedom from conversion to open surgical repair, 100% freedom from type I and III endoleaks, and 100% freedom from device migration.
According to TriVascular, these results were compelling when analysing clinically complex patient subsets. Subset analysis of patients with proximal aortic neck lengths less than 10mm, as well as patients who presented with hostile aortic neck anatomy, showed 100% freedom from: type I and III endoleaks, rupture, migration, and conversion to surgical repair. Notably, the company added, the data continue to provide evidence of proximal aortic neck protection.
The Ovation system’s polymer-filled sealing rings are designed to insulate the aortic neck from blood pressure and do not exert chronic outward force on the vessel wall. The Ovation three-year data, unlike data from studies using conventional self-expanding stent grafts, show that the mechanism of proximal sealing does not provoke neck dilatation. The results were presented by Manish Mehta, director of Endovascular Services at the Vascular Institute for Health & Disease in Albany, USA, who was the principal investigator for the Ovation Pivotal Trial.
“I am encouraged by the three-year results from the Ovation Pivotal trial,” commented Mehta. “The follow-up suggests that the Ovation system is an important addition to the treatment tool kit for EVAR practitioners. The safety and performance metrics are compelling across a broad range of patients, but especially so when you consider the clinical complexity of this study’s patient cohort. Many of the patients treated in the trial would not be eligible for on-label EVAR prior to the Ovation platform. I look forward to additional trial results as patient follow-up and subset analysis continue.”
The Ovation Pivotal trial enrolled 161 patients across 36 sites and three countries. A further 77 patients were treated in a Continued Access arm at 28 sites in the United States. In the pivotal study cohort, nearly 40% of the patients treated would be considered off-label for conventional stent graft technology.
“We are excited, and proud, to share these three-year Ovation trial results,” said Christopher G Chavez, chairman, chief executive officer and president of TriVascular. “TriVascular is committed to clinical research and to providing physicians with the evidence they need to gain confidence in our technology. Ultimately, it is this confidence that will enable more patients to gain access to this less invasive, clinically proven, and life-saving therapy. Going forward, we will continue to invest in the generation of clinical data to prove, definitively, the multitude of clinical advantages offered by the Ovation platform.”
The Ovation system has been used in the successful treatment of over 4,500 patients worldwide. In addition to the Ovation Pivotal Trial, excellent clinical results have been reported from a 501-patient European Post-Market Registry. The Ovation and Ovation Prime systems are available for sale in over 25 countries around the world.