QT Vascular wins CE Mark for Chocolate Heart DCB

QT Vascular said today that it won CE Mark approval in the European Union for its Chocolate Heart drug-coated balloon for treating coronary artery disease. The Chocolate Heart device is a paclitaxel-coated version of the Chocolate balloon that won FDA approval back in June 2014, the Singapore-based company said. “We are delighted with the CE Mark clearance of our novel Chocolate Heart drug-coated PTCA balloon,” CEO Eitan Konstantino said in prepared remarks. “The opportunity to minimize the use of metallic stents is greater in the coronary compared to any other arteries. We intend to increase our focus on the coronary business and build evidence to help improve patients care.” In September 2015, the company won CE Mark approval for its Chocolate Touch balloon for treating peripheral artery disease. In February, a federal appeals court reversed a $20 million loss for QT Vascular and sister companies Quattro Vascular and TriReme Medical, sending the case back to a lower court to reconsider whether founder Konstantino violated his duties to AngioScore when he started his trio of competing firms. AngioScore, which Spectranetics (NSDQ:SPNC) acquired in 2014 for $230 million, accused Konstantino of breaching his fiduciary duties to AngioScore by developing the Chocolate balloon catheter, which competes with AngioScore’s AngioSculpt balloon. The lawsuit, filed in June 2012 in the U.S. District Court for Northern California, also accused TriReme...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Drug-Device Combinations Regulatory/Compliance QT Vascular Source Type: news