PLEASANTON, Calif., June 21, 2017 /PRNewswire/ -- TriReme Medical LLC (the "Company"), a subsidiary of QT Vascular Ltd, announced today its angiographic data from 24-month follow-up of patients with De Novo lesions treated with Chocolate Heart™ as a standalone therapy. The initial six-month results were announced on 5 January 2016.
Chocolate Heart™ is the drug-coated version of the Chocolate® coronary balloon that is commercially available in the United States. The Company has added a proprietary coating with paclitaxel to the Chocolate® coronary balloon to reduce the incidence of repeat procedures. This combination of the Chocolate® technology and the therapeutic agent is intended to allow certain patients to be treated with Chocolate Heart™, minimizing the need for a stent.
The First-In-Human study was conducted at CECANOT Hospital in Santo Domingo, Dominican Republic. The follow-up included 14 patients treated with Chocolate Heart™ that would have otherwise received a stent. The results show no late lumen loss (negative 0.06) and no further interventions were needed at two 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." said Carlos H. Garcia-Lithgow, MD, Head of interventional Cardiology, CECANOT, Santa Domingo, Dominican Republic and the Study Principal Investigator.
"These are impressive 24-month angiographic results showing negative late loss which basically means the arteries stayed wide open after two 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," stated Alexandra Lansky, MD, Professor of Medicine, Heart and Vascular Clinical Research Program Yale University School of Medicine.
"We are delighted with the angiographic results of Chocolate Heart™ showing maintenance of patency at two years," stated Eitan Konstantino, PhD, CEO of QT Vascular. "Those patients are doing well without a stent in their heart and this is exactly what we are here for."
Chocolate Heart™ is not approved for use in the United States and CE mark does not constitute such approval.
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SOURCE TriReme Medical, Inc.