TriVascular announced on 22 March 2010 the first European clinical study implants of its Ovation Abdominal Stent Graft. The innovative, low-profile system is designed to expand the patient population suitable for endovascular aortic repair (EVAR) by addressing a wider range of diseased anatomy. Cases were performed in Germany by Thomas Nolte, chief of Vascular Surgery at Herz- und Gefäßzentrums Bad Bevensen, and Horst Sievert, director of the CardioVascular Center Frankfurt.
“The Ovation Abdominal Stent Graft performed exceptionally well,” said Nolte, principal investigator for the European study. “The clinical benefits of the reduced profile and unique sealing technology were evident immediately. I believe this offering will expand the pool of patients to whom I can offer an endovascular solution.”
The European clinical study will evaluate the safety and performance of the Ovation system. In the United States, the Ovation stent graft is an investigational device and currently not approved for sale.
“I was very pleased with the performance of the Ovation stent graft,” said Sievert. “The system was easy to use and addresses many of the limitations of current generation devices, especially in cases of difficult anatomy and iliac access.” Sievert utilised a bilateral percutaneous approach to gain femoral access.
“The start of our European clinical study is a significant milestone for our organisation,” said Mike Chobotov, president and CEO of TriVascular. “We are fortunate to partner with thought leading clinicians in Europe. More importantly, we are excited to provide next generation endovascular solutions to patients suffering from aortic disease.”