TriVascular announced the launch of the Ovation Abdominal Stent Graft System at the Leipzig Interventional Course (LINC) annual meeting in Germany. The company received CE mark approval last year and initiated a pilot release. The commercial rollout builds upon the success of the pilot phase. At 14F outer diameter, Ovation is the lowest profile system on the market and expands the patient population suitable for EVAR.
“Ovation represents a truly next generation offering for EVAR. The very low-profile system separates, and optimises, the two most important requirements of EVAR: fixation and seal,” said Dierk Scheinert, head of the Department of Medicine, Angiology and Cardiology and Chairman of the Center for Vascular Medicine at the Park-Krankenhaus Leipzig. “We believe that this novel approach serves to expand the patient population that can benefit from minimally invasive aneurysm repair. We are excited to offer this technology to our patients.”
“The clinical performance is quite compelling,” said Michael Dake, professor, Cardiothoracic Surgery at Stanford University School of Medicine, USA. “Across three continents, and within a diverse mix of patients, Ovation has performed very well.”
TriVascular is currently conducting a US investigational device exemption (IDE) study to evaluate the safety and effectiveness of the Ovation Abdominal Stent Graft System. In the United States, the Ovation Abdominal Stent Graft System is an investigational device and currently not approved for sale.