FDA Approves Covered Stent For Treatment of Aortic Wall Injury
The U.S. Food and Drug Administration (FDA) recently approved the NuMED Cheatham Platinum (CP) Stent System for the prevention and/or treatment of aortic wall injury (AWI) 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.
Stent therapy for coarctation of the aorta offers a non-surgical alternative to traditional operative repair of the aortic obstruction with similar results and complication rates. Stent treatment also has a lower rate of recurrence and aortic wall injury compared to balloon dilation alone.
Covered stent therapy provides similar outcomes and allows for simultaneous treatment of aortic wall injuries, such as aneurysm and pseudo-aneurysm that might be present, related to previous surgical or catheter based therapy of the coarctation.
In the COAST II clinical trial, published in JACC: Cardiovascular Interventions, the average ascending-to-descending aorta systolic gradient improved from 27 ± 20 mm Hg to 4 ± 6 mm Hg. Complete coverage of pre-existing AWI was achieved in 66 of 71 patients (93 percent) with AWI who received the stent. No patients have required additional or subsequent surgical therapy. Approximately 15 percent of patients require further dilation of the stent after a few years, mostly to keep up with patient growth. Only two patients experienced clinically apparent access artery injury, requiring repair. Subclinical femoral artery injury was suspected in nine patients and borderline femoral artery injury occurred in ten additional patients.
“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.”
He adds that, “For years coarctation of the aorta therapy has been conducted safely by catheter techniques in the catheterization laboratory. However, the risk of serious, life threatening complication has now been further reduced by giving physicians the ability to immediately repair an unexpected aortic tear. Furthermore, physicians can hopefully make aortic tears even rarer, by using the Covered CP stent prophylactically when treating coarctation of the aorta in high risk patients.”
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