FDA approves clinical trial for QT Vascular ’ s Chocolate Touch DCB

QT Vascular said today that it won an investigational device exemption from the FDA for a pivotal study of its Chocolate Touch drug-coated balloon. The device won the CE Mark for treating peripheral artery disease in September 2015 and in July it won approval for treating coronary artery disease. The Singapore-based company is slated to enroll patients in the U.S., Europe and New Zealand to evaluate the efficacy of the Chocolate Touch DCB. The study is designed to compare that device with C.R. Bard’s (NYSE:BCR) Lutonix balloon to treat patients with peripheral vascular disease. “We are thrilled to receive this conditional IDE approval from FDA,” CEO Eitan Konstantino said in prepared remarks. “This approval concludes a highly sophisticated research effort and marks a significant step towards joining the exclusive list of companies able to sell drug-coated balloons in the US.” In February, a federal appeals court sent a possible $20 million loss for QT Vascular and its sister companies Quattro Vascular and TriReme Medical back to a lower court to reconsider whether founder Konstantino violated his duties to AngioScore when he founded QT Vascular. AngioScore accused Konstantino of breaching his fiduciary duties to the company by developing the Chocolate balloon device, which competes with AngioScore’s AngioSculpt balloon. The lawsuit was filed in June 2012 in the U.S. District Court for Northern California. The suit alleged that TriReme, Quatto and Q...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) AngioScore Inc. Peripheral Artery Disease QT Vascular Source Type: news