On 29 April 2014, TriVascular Technologies announced FDA-approved changes to the indication statement for the Ovation and Ovation Prime Abdominal Stent Graft Systems (Ovation system).
The expanded indication for use statement eliminates the minimum aortic neck length requirement and also includes clarification on appropriate vascular access techniques. The Ovation Abdominal Stent Graft System received FDA PMA approval in October 2012. The PMA-S approval for the Ovation Prime Abdominal Stent Graft System followed in December 2012.
According to TriVascular, the Ovation system, with its unique sealing technology, is now the only FDA-approved EVAR stent graft that is not restricted by the conventional measurement of aortic neck length in its labeling. The Ovation system utilises an innovative, polymer-filled sealing ring that does not exert chronic outward force, and protects the aortic neck from dilatation by insulating it from the force of blood pressure. Unlike conventional self-expanding stent grafts, 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 statement provides that the Ovation system may be used when the inner wall diameter is no less than 16mm and no greater than 30mm at 13mm below the inferior renal artery.
Neck length is only considered in assessing angulation: patients with a proximal neck length of less than 10mm are indicated with an aortic angle of less than or equal to 45 degrees; otherwise angles up to 60 degrees are indicated.
“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,” commented Manish Mehta, director of Endovascular Services at the Vascular Institute for Health & Disease in Albany, USA, who was the principal investigator for the Ovation pivotal clinical trial. “The pivotal trial clinical results out to two years are excellent, and include data demonstrating complete absence of aortic neck dilatation.”
The expanded 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 prior Indications for Use. This change includes the word percutaneous directly in the indication statement. Examining an available database of 43,000 patient scans, 85% of those patients had an aortic neck length and access vessel diameter within the Ovation system’s revised indication statement.
“The recent approval from the FDA serves as a testament to the novel, innovative approach that the Ovation system offers and serves to increase the patient population suitable for EVAR with the Ovation system,” said Christopher G. Chavez, chairman, CEO and president of TriVascular. “Based on a minimum neck length requirement of conventional self-expanding stent grafts and their associated system profile of 18F OD or greater, the majority of diagnosed abdominal aortic aneurysm patients did not have an on-label option for EVAR prior to FDA approval of the Ovation system. With the Ovation system’s innovative sealing ring technology and ultra-low profile 14F OD system, a majority of diagnosed abdominal aortic aneurysm patients now have an on-label, clinically proven solution.”
The Ovation system has been used in the successful treatment of over 3,500 patients worldwide. According to TriVascular, excellent clinical results have been reported from both the Ovation global pivotal trial and a 500-patient European Post-Market Registry. In the pre-market clinical trial, the Ovation system demonstrated 100% freedom from type I and III Endoleaks at two years, as well as no aortic neck dilatation through the two year mark. The Ovation and Ovation Prime systems are available for sale in over 25 countries around the world.