The FDA approved the COBRA PzF NanoCoated coronary stent system to improve coronary luminal diameter in certain patients with ischemic heart disease.
CeloNova Biosciences, which manufactures the stent system, announced the approval on March 1.
The company said the stent is indicated for patients with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with reference vessel diameter of 2.5 mm to four mm and a lesion length of 24 mm or less. Patients who receive the COBRA PzF also must take dual antiplatelet therapy for at least 30 days following the intervention.
The FDA approval was based on results of the PzF SHIELD trial, which enrolled 296 patients with symptomatic ischemic heart disease at 35 centers in the U.S. and other countries.
All of patients were treated with the COBRA PzF stent. After nine months, no patients had stent thrombosis and 4.6 percent of patients had target lesion revascularization. Target vessel failure occurred in 11.5 percent of patients. One patient had a cardiac death, 7 percent had an MI and 5.9 percent had target vessel revascularization. The full results were published in the Journal of the American College of Cardiology: Cardiovascular Interventions on Jan. 23.
The COBRA PzF stent received a CE Mark in 2012 and launched in Europe and the Middle East in 2013.
In February 2016, CeloNova Biosciences began enrolling patients in the randomized COBRA REDUCE trial, which is comparing the COBRA PzF stent with drug eluting stents. The company said researchers are examining whether the COBRA PzF stent can help reduce bleeding by reducing dual antiplatelet therapy to 14 days in patients who are at high risk for bleeding and require treatment for coronary artery disease.
“There continues to be an unmet clinical need for patients who may not be candidates for drug-eluting stents or longer term dual antiplatelet therapy,” Donald Cutlip, MD, principal investigator of the PzF SHIELD trial and professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, said in a news release. “Given the observed low rates of stent thrombosis and target lesion revascularization that need to be confirmed in future studies, the COBRA PzF stent system may hold potential unique benefit for these patients.”
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.