The Chocolate Heart device is a paclitaxel-coated version of the company’s Chocolate coronary balloon that is commercially available in the U.S. The combo therapy was designed to reduce the incidence of repeat procedures and minimize the need for a stent, according to TriReme.
The 1st-in-human study involved 14 patients treated with the Chocolate Heart device that would have otherwise received a stent. The data showed no late lumen loss and TriReme reported that no further interventions were needed after 2 years.
“I would like to change my approaches for coronary arteries and use more drug-coated Chocolate balloons; I believe it may be the best for my patients.” principal investigator Dr. Carlos Garcia-Lithgow said in prepared remarks.
“These are impressive 24-month angiographic results showing negative late loss which basically means the arteries stayed wide open after 2 years. When compared to published data on drug-eluting coronary stents (0.1– 0.3mm of late lumen loss at 9-13 months); these data suggest that permanent implants could be avoided in a subset of patients. This is a small study and if the data is confirmed in larger studies, it could lead to a change in the way coronary lesions are treated,” Dr. Alexandra Lansky, a professor of medicine at Yale University, said.
The Chocolate Heart drug-coated balloon won CE Mark approval in July last year and is not yet approved for use in the U.S.
“We are delighted with the angiographic results of Chocolate Heart showing maintenance of patency at 2 years,” QT Vascular CEO Eitan Konstantino added. “Those patients are doing well without a stent in their heart and this is exactly what we are here for.”