TriVascular’s Ovation stent-graft system received FDA approval for endovascular treatment of AAA last month. The device features a low-profile 14F delivery system – a 4.7 mm outer-diameter (OD) carrying catheter for the main body. It is expected to expand the reach of EVAR, especially to many female patients and others with small and otherwise disadvantaged access femoral-iliac arteries.
It should be noted that TriVascular had already received CE Mark European approval in August 2010. According to the company, the Ovation pivotal IDE clinical trial enrolled 161 patients at 36 sites from the United States, Germany, and Chile.
Forty percent of the patients treated had complex anatomies, with proximal neck lengths shorter than 10 mm, distal access vessels smaller than 6 mm, or both; 43% of the patients were treated percutaneously. There were no device-related major adverse events, no aneurysm ruptures, and no conversions to open repair. Core-lab scrutiny of the post EVAR images uncovered no type I or III endoleaks, and no migration.
Ovation becomes the first commercially available ultra-low-profile EVAR stent-graft system with an impressively small 14F OD diameter. This is much smaller than anything we have ever had access to and may well change the abdominal aortic aneurysm treatment landscape significantly as adoption increases rapidly in the foreseeable future.
But tempering such enthusiasm is the recognition that the device remains – essentially – clinically unproven because of the lack of long-term data and the small number of treated patients.
Time will tell.