Cook Medical has released initial results from its STABLE clinical trial that is designed to evaluate the safety and efficacy of a proximal endograft and a distal uncovered stent for the endovascular treatment of Type B aortic dissection.
The Cook Medical stent-graft system is comprised of two components an endograft that seals the torn aortic section, and a second, uncovered stent that helps to support the true lumen of the aorta and promote apposition of the dissected vessel wall.
The trial’s focus is on a device designed for the endovascular treatment of Type B aortic dissection and the system as a whole is an investigational device not available in the US.
Cook Medical Aortic Intervention strategic business unit vice president Phil Nowell said that they are pleased with the initial data, and signifies an important step forward for Cook’s minimally invasive system for treating aortic dissection.
"Open surgery to repair dissection can take a devastating toll on a patient, and we hope the STABLE trial final results support an endovascular solution," Nowell said.