January 16, 2019:
Chocolate Touch® drug-coated balloon: QT Vascular Ltd., has announced that the United States Food and Drug Administration has granted approval to include the use of atherectomy for lesion preparation in its ongoing Chocolate Touch® drug-coated balloon pivotal study and addition of subgroup analysis related to the use of atherectomy. Atherectomy is an important vessel preparation modality that is commonly used in United States (“US“) hospitals and Outpatients Based Labs (“OBL“). (QT Vascular Ltd., (the “Company” or “QT Vascular“, and together with its subsidiaries, the “Group“), is a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease.
The Chocolate Touch® US pivotal study is a prospective randomized study in the US, Europe, and New Zealand that will evaluate patients with disease in the superficial femoral and popliteal arteries in the legs. Patients are randomized 1:1 to CR Bard’s Lutonix drug-coated balloon. The study evaluates acute end points such as procedural successes and freedom from bail-out stenting, and long term endpoints such as patency and target lesion revascularization among others.
Chocolate Touch® drug-coated balloon pivotal study is being conducted in up to 50 centers in the US and selected centers outside the US. The Co-Principal Investigators of the study are Dr. Mehdi Shishehbor of the University Hospitals Harrington Heart and Vascular Institute in Cleveland and Professor Thomas Zeller of the Heart Center in Bad Krozingen, Germany.
“The inclusion of atherectomy in the study is a unique element that expands the potential use of Chocolate Touch®, both in hospitals and OBL,” said Dr. Mehdi Shishehbor. “The study will provide an important data set that is consistent with real world practice, especially at OBL where more and more patients are getting treated.”
Chocolate Touch® is the drug-coated version of the Company’s Chocolate® PTA balloon which was acquired by Medtronic, Inc. (the completion of which was announced on January 29, 2018) and is broadly available in hospitals across the US. Chocolate Touch® is not commercially available in the US and can only be used in the IDE clinical study. The study is registered on www.clinicaltrials.gov (NCT02924857). Chocolate Touch® received CE Mark on August 2015 and is available in EU and other countries.