TriVascular Technologies, manufacturer of the Ovation Abdominal Stent Graft platform, announced on 3 August 2015 two major clinical milestones: surpassing 100 patients enrolled in the LIFE (Least invasive fast-track EVAR) study and completion of patient enrolment in the US Post Approval Study. These achievements demonstrate the company’s ongoing commitment to significantly advance endovascular aortic repair (EVAR) of abdominal aortic aneurysms.
The LIFE study is designed to evaluate clinical outcomes and healthcare economic data on patients treated with the Ovation system utilising the Fast-Track treatment protocol. Under Fast-Track, vessel access is gained via a bilateral percutaneous approach, local or regional anaesthesia is utilised, intensive care unit admission post-procedure is avoided and the patient is discharged the following day. This patient-friendly, resource-efficient treatment pathway is enabled by the Ovation system and has the potential to meaningfully improve the practice of EVAR. The LIFE study is led by co-national principal investigators Zvonimir Krajcer, co-director, Peripheral Vascular Disease Service at Texas Heart Institute in Houston, USA, and Venkatesh G Ramaiah, director of Research at the Arizona Heart Institute and Medical Director of the Arizona Heart Hospital in Phoenix, USA.
“The Ovation system’s low profile, and proven clinical value, when combined with less invasive percutaneous access and the potential to avoid general anaesthesia, should yield excellent patient outcomes with lower costs, shorter procedures and high patient satisfaction,” said Krajcer. “Dr Ramaiah and I are excited to partner with TriVascular on this important registry. The results of the LIFE study will significantly contribute to the existing literature and add momentum to the inevitable transition toward a fast-track, next-day discharge EVAR protocol.”
TriVascular also announced the completion of the US Post Approval Study (PAS). The PAS is a prospective, multicentre study that further evaluates the safety and effectiveness of the Ovation platform in a real world clinical setting. This study augments the Ovation global pivotal trial cohort as outlined in the conditions of the premarket approval application (PMA) with patients followed for up to five years, per the required study timeline.
“By a considerable margin, the Ovation system has the broadest indications for use of any system and, as a result, has allowed us to treat patients that are otherwise ineligible for an on-label EVAR solution,” commented Syed Hussain, the PAS national principal investigator, chairman of Vascular and Endovascular Surgery at Christie Clinic and assistant professor of Surgery at the University of Illinois. “We are excited to have partnered with TriVascular on this important study. The ongoing results of the study will further expand the clinical evidence demonstrating the safety and effectiveness profile of the Ovation system. In our practice, the Ovation system is our frontline device.”
“We are focused on developing products and providing clinical evidence to help expand EVAR access to more patients and improve EVAR outcomes for all patients,” said Christopher G Chavez, chairman, CEO and president of TriVascular. “We are excited to have reached these major clinical milestones and are grateful to all of the study investigators who put their trust in our technology when caring for their patients.”
The Ovation platform has been used in the successful treatment of over 7,000 patients worldwide. According to TriVascular, excellent clinical results have been reported from both the Ovation global pivotal trial and a 501-patient European Post-Market Registry. The Ovation platform is available for sale in over 35 countries.