FDA Approves Nanocoated Cardiac Stent as Alternative Device for Heart Disease Patients

Patients with coronary artery disease are often treated using surgically-implanted cardiac stents, which help to ensure a consistent supply of blood to the heart. While these medical devices have been shown to speed recovery after a heart attack, they are more controversial in the treatment of patients with stable angina.

In 2011, a study published in the Journal of the American Medical Association found that only half of all stent procedures recorded in the National Cardiovascular Data Registry, were appropriate. Despite the debate surrounding the procedure, medical device company CeloNova Biosciences believe their nanocoated stent may be a good alternative to traditional drug-eluting stents for some patients.

The Cobra PzF Nano Coated stent is composed of cobalt chromium alloy, which is coated with a biocompatible polymer of Polyzene-F. The device – which was just approved by the FDA this week – has the major advantage of requiring patients to be on blood thinning drugs for a shorter period of time after surgery.

Conventional drug-eluting stents require patients to be on dual anti-platelet therapy (DAPT) for six to 12 months after the stent is inserted. For patients treated with CeloNova’s stent, DAPT therapy could be completed in as little as 30 days post-op; this timeline is on par with uncoated metal stents.

According to the company, a clinical trial of the stent found that the incidence of stent thrombosis – a complication of surgery in which a blood clot blocks the flow of blood in the stented artery – was non-existent in the nine months following surgery. Other commonly-used devices have a stent thrombosis rate of 0.7 percent each year.

“We are pleased to have met our primary endpoint and are reassured by low rates of stent thrombosis and target lesion revascularization that need to be confirmed in future studies,” said Dr. Donald Cutlip, principal investigator of the trial and professor of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School in Boston. “The results hold potential unique benefit for patients who may not be candidates for drug-eluting stents or longer term dual antiplatelet therapy, a continued unmet clinical need.”

According to Dennert Ware, executive chairman and acting CEO of CeloNova, the stent represents an additional option for patients who are at a high risk of bleeding. The biocompatibility of the polymer device coating is designed to attract proteins that are critical to the healing process, while repelling those that encourage clotting.

“What often happens is that people who require a stent are also people who are older and have comorbidities,” Ware told MedCity News. “That increases the probability of bleeding and in those cases we offer a far superior alternative, a choice the doctor can make to keep the patient safe.”

The device is now being compared to drug-eluting stents in the COBRA REDUCE clinical trial. While the nanocoated stent is newly-approved in the US, it is already being used in Europe and the Middle East.