TriVascular Initiates the OVATION Post-Market Registry in Europe

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Global study of innovative, low-profile system to enroll 500 patients at 30 sites

TriVascular, Inc. announced, at the 33rd annual Charing Cross International Symposium, the start of OVATION, a multicenter, prospective, post-market study, which will evaluate the safety and performance of the OvationTM Abdominal Stent Graft System. This study will evaluate treatment of abdominal aortic aneurysms (AAA) in the real-world setting of routine clinical practice.

"I am pleased to be partnering with TriVascular on this important clinical effort,” said Matt Thompson, MD, FRCS, Professor of Vascular Surgery, St George's Vascular Institute. “I believe the Ovation Abdominal Stent Graft has the potential to offer minimally invasive EVAR to a broader cohort of patients.” Professor Thompson is the Coordinating Investigator for the OVATION study and leads the study Steering Committee, whose members include:

  • Dr. Afshin Assadian, Wilhelminenspital der Stadt Wien, Austria
  • Prof. Jean-Pierre Becquemin, University Hospital Paris XII, France
  • Prof. Roberto Chiesa, Università Vita-Salute San Raffaele, Italy
  • Prof. Hans-Henning Eckstein, Klinikum rechts der Isar der TU-München, Germany
  • Dr. Hans Krankenberg, Universitäres Herz und Gefässzentrum Hamburg, Germany
  • Prof. Frans Moll, University Medical Center Utrecht, Netherlands
  • Prof. Claudio Rabbia, Molinette Hospital, Italy
  • Prof. Vicente Riambau, Hospital Clínico de Barcelona, Spain

Patients who meet the study’s single-arm inclusion criteria will be treated with the Ovation Abdominal Stent Graft and followed for five years. The study’s primary endpoint is treatment success, a composite of technical and clinical success at 12 months. Technical success includes successful delivery and deployment of the stent graft. Clinical success includes freedom from aneurysm expansion, aneurysm rupture, type I and III endoleak, conversion to open surgical repair, stent graft migration, and stent graft occlusion.

TriVascular launched the Ovation Abdominal Stent Graft System in Europe in January 2011. At 14F OD, Ovation is the lowest profile commercially available AAA device, and is designed to expand the pool of treatable patients by addressing a wider range of diseased anatomy. In the United States, Ovation is an investigational device and not currently available for sale. Enrollment in the U.S. IDE study was completed in March 2011.

“We are excited to partner with thought leading clinicians in Europe to enhance the body of clinical data supporting Ovation,” said Michael Chobotov, Ph.D., President and CEO of TriVascular, Inc. “We are committed to gathering clinical evidence and believe the data will demonstrate enhanced benefits of EVAR across a broader patient population”.

About TriVascular, Inc. - TriVascular’s initial product offerings are novel endovascular grafts focused on significantly advancing EVAR. Building upon partnerships with thought leading clinicians worldwide, TriVascular’s products are designed to address unmet clinical needs and expand the pool of patients who are candidates for EVAR. Based in Santa Rosa, California, TriVascular offers highly talented, motivated individuals the opportunity to positively impact global healthcare.

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Vivek Jayaraman
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