FDA Approves Covered Stent For Treatment of Aortic Wall Injury

The U.S. Food and Drug Administration recently approved the Cheatham Platinum Stent System for the prevention and/or treatment of aortic wall injury in patients with coarctation of the aorta involving a compliant aortic isthmus or first segment of the descending aorta where there is adequate size and patency of at least one femoral artery and balloon angioplasty is contraindicated or predicted to be ineffective. “FDA approval of the NuMED CP and Covered CP stents marks important milestones in the catheter mediated therapy of children and adults with congenital heart disease,” states Richard E. Ringel, MD, FACC, a professor of pediatrics in the division of pediatric cardiology at Johns Hopkins School of Medicine. “These are the first large diameter, balloon expandable stents to be approved by the FDA for usage in the aorta. The Covered CP stent increases the safety of therapy for coarctation of the aorta.” Read more on ACC.org.