First Patients Treated in TriVascular’s OVATION Post Market Registry
SANTA ROSA, Calif., July 25, 2011 /PRNewswire/ — TriVascular, Inc. today announced the successful treatment of the first 5 patients in the OVATION study, a multicenter, prospective, European Post Market Registry. The patients were treated in Germany at Stadtisches Klinikum, Karlsruhe by Prof. Martin Storck and at Universitares Herz und Gefasszentrum, Hamburg by Dr. Hans Krankenberg.
“It is an honor to be the first site to enroll a patient in TriVascular’s OVATION study. Ovation’s low-profile, 14F outer diameter design and sealing ring technology show great promise in the treatment of AAA across a broad patient population,” said Martin Storck, MD, Professor of Vascular Surgery, Karlsruhe, Germany.
This study, which will evaluate treatment of abdominal aortic aneurysms (AAA) in the real-world setting of routine clinical practice, will enroll 500 patients at 30 sites in Europe. Matt Thompson, MD, FRCS, Professor of Vascular Surgery, St George’s Vascular Institute is serving as the study’s coordinating investigator.
“Our participation in the original study gave us a very favorable view of Ovation. Our first patients were treated over a year ago, with excellent results. Through the OVATION study, we are pleased to continue our clinical partnership with TriVascular and learn how Ovation performs in real-world clinical practice,” said Hans Krankenberg, MD after enrolling 4 patients in the registry.
Patients enrolled in the study 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.
“We are excited to begin the OVATION post market registry,” said Michael Chobotov, Ph.D., President and CEO of TriVascular, Inc. “This study further demonstrates our commitment to generating data on Ovation, and we are grateful for the strong support from the physician community.”
TriVascular’s Ovation Abdominal Stent Graft System was launched commercially 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 anatomies. 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.
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.
SOURCE TriVascular, Inc.