Neck and Access Indications Modified for TriVascular's Ovation and Ovation Prime EVAR Systems

April 29, 2014—TriVascular Technologies, Inc. announced that the US Food and Drug Administration (FDA) has approved a modification to the indications for the company’s Ovation and Ovation Prime abdominal stent graft systems. The modified indication for use statement clarifies the unique anatomical considerations for patient selection and also includes clarification on appropriate vascular access techniques. The Ovation system received FDA approval in October 2012. The Ovation Prime system was approved in December 2012.

According to TriVascular, the Ovation systems utilize the company’s polymer-filled sealing ring, which does not exert chronic outward force and protects the aortic neck from dilatation by insulating it from the force of blood pressure. The Ovation system does not require a minimum length of parallel vessel walls in order to achieve aneurysm seal. The sealing ring provides circumferential seal at a specified location in the aorta.

The clarified indication states that the Ovation systems may be used when the inner wall diameter is no less than 16 mm and no greater than 30 mm at 13 mm below the inferior renal artery. Neck length is only considered in assessing angulation: patients with a proximal neck length of less than 10 mm are indicated with an aortic angle of less than or equal to 45º; otherwise, angles up to 60º are indicated.

The modified indication statement also includes a clarification that both percutaneous access and femoral cutdown are appropriate vascular access techniques. The option for either percutaneous or femoral cutdown was already approved in the previous indications for use. This change includes the word “percutaneous” directly in the indication statement. 

In the company’s press release, Manish Mehta, MD, who served as the Principal Investigator for the Ovation pivotal clinical trial, commented, “I am pleased to see the recent update to the Ovation system indications for use. This provides support that TriVascular’s innovative sealing ring technology is very different from conventional stent grafts, and provides the less invasive solution, even in patients with hostile aortic neck anatomy. The pivotal trial clinical results out to 2 years are excellent, and include data demonstrating complete absence of aortic neck dilatation.” Dr. Mehta is Director of Endovascular Services at the Vascular Institute for Health & Disease in Albany, New York.