Study investigators reported positive steps in Cook Medical’s efforts to gain FDA approval of the treatment assessed in the STABLE clinical trial, 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 for purposes of seeking FDA approval.
The findings were presented by Joseph Lombardi at the VEITHsymposium in November 2010. The trial is the first and only one of its kind to focus on a device uniquely designed for the endovascular treatment of type B aortic dissection. The system as a whole is an investigational device not available in the United States.
“The initial data for the STABLE clinical trial show promise,” said Lombardi, the study’s principal investigator and chief of vascular and endovascular surgery at Cooper University Hospital and associate professor of surgery at the Robert Wood Johnson Medical School, University of Medicine & Dentistry of New Jersey. “Aortic dissection can be a life-threatening condition, and surgical intervention is a highly invasive procedure. If confirmed, these initial results are a positive step toward proving the safety and efficacy of a minimally invasive treatment for aortic dissection.”
“We are very pleased with the initial data, and this signifies an important step forward for Cook’s minimally invasive system for treating aortic dissection,” said Phil Nowell, vice president and global leader of Cook Medical’s Aortic Intervention strategic business unit. “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.”
The Cook 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.