There is a concern that cardiac stents are overused.
In fact, a study published in the Journal of the American Medical Association in 2011 found that only 50 percent of stent procedures reflected in the National Cardiovascular Data Registry, were categorized as appropriate. Back in 2015, a pilot program won grant money from the Centers for Medicare and Medicaid Services to understand how physicians make decisions on stenting and other cardiovascular procedures and lay the ground for proper physician education and change.
While value-based care models are making their way into cardiac care, one company in San Antonio, Texas believes that it’s nanocoated stent will appeal to physicians who are looking for alternatives to drug-eluting stents for patients with high risk of bleeding.
CeloNova Biosciences, whose Cobra PzF Nano Coated stent is coated with a thin biocompatible polymer, announced Wednesday that the Food and Drug Administration has approved the device.
One of the device’s chief attractions is that patients need to be on dual anti-platelet therapy for a much shorter period of time following the stenting, said Dennert Ware, executive chairman and acting CEO of CeloNova, in a phone interview prior to the approval. The company’s approval announcement said the DAPT therapy needs to continue for a minimum of 30 days.
Compare that to drug-eluting stents, where DAPT therapy continues for 6-to-12 months following the procedure. For bare metal stents, the period is lower — one month.
CeloNova’s Cobra stent is made of cobalt chromium with a proprietary Polyzene-F nano-thin polymer. Data presented to FDA for approval found that stent thrombosis — a complication of stenting — was non-existent 9 months after the Cobra was inserted.
Device thrombosis occurs when a thrombus or blood clot suddenly forms in a stented coronary artery impeding blood flow…