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March 16, 2014

Five-Year Results Support TEVAR With Cook's Zenith TX2

March 17, 2014—Jon S. Matsumura, MD, et al published 5-year results from a clinical trial evaluating the Zenith TX2 graft (Cook Medical, Bloomington, IN) for thoracic endovascular aortic repair (TEVAR) compared with open surgical repair of descending thoracic aortic aneurysms and large ulcers at 42 international sites. The study is available online ahead of print in the Journal of Vascular Surgery.

The background of the study is that although several studies have demonstrated early safety and advantages with TEVAR, longer follow-up is needed due to concerns about durability.

As summarized in the Journal of Vascular Surgery, this prospective, nonrandomized study enrolled 160 TEVAR patients treated with the Zenith TX2 device and 70 open surgical repair patients.

The investigators reported that although follow-up was limited, the 5-year mortality rate was similar for both groups at 37%. The aneurysm-related mortality rate was 5.9% with TEVAR compared to 12% with open surgical repair (P = .11). There were no ruptures of the treated aneurysms in either group or open conversions in the TEVAR group. Predefined severe morbidity occurred at a significantly lower rate in the TEVAR group (21%) compared with the open surgical repair group (39%; P < .001). Aneurysm growth was seen by the core laboratory in 5.9% of patients and endoleak in 5.7% of patients. Secondary intervention rates were similar between TEVAR (8%) and open surgical repair (12%; P = .49).

The investigators found that the 5-year results indicate similar all-cause mortality and aneurysm-related mortality with TEVAR compared with open repair. There was a persistent reduction of severe complications with TEVAR. Reinterventions occurred with similar frequency. 

The investigators concluded that TEVAR with the Zenith TX2 graft is a safe and effective alternative to open surgical repair for the treatment of anatomically suitable descending thoracic aortic aneurysms and ulcers.

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March 17, 2014

Biocardia's Morph AccessPro Steerable Introducer Approved in Europe

March 17, 2014

Biocardia's Morph AccessPro Steerable Introducer Approved in Europe