Cook Medical said it won premarket approval from the FDA for its Zenith Alpha thoracic endovascular stent graft designed for patients with isolated lesions of the descending thoracic aorta.
The approval came based on 2 pivotal clinical trials examining the safety and effectiveness of the graft in patients with aortic aneurysms or ulcers or with blunt traumatic aortic injuries, Cook said.
“Despite all the successes we’ve seen over the past few decades in endovascular aneurysm repair, we continue to be frustrated when we have to put a large sheath through iliac arteries that are smaller than the delivery system. Development, testing, and now approval of the Zenith Alpha Thoracic device is long-awaited in this regard,” Dr. Karl Illig of the USF Morsani College of Medicine said in prepared remarks.
The Zenith Alpha is the company’s new lower-profile stent graft, which is delivered with a 16-20 French delivery system designed to address vascular access issues associated with larger devices.
“The approval of Zenith Alpha thoracic accelerates Cook Medical’s vision to provide physicians with disease-specific treatment options that fit each patient’s unique anatomy and disease state,” aortic intervention division veep Nicky James said in a press release.
The Zenith Alpha Thoracic won CE Mark approval in 2013, and has been launched and commercialized in Europe.