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, Quattro and QT Vascular of abetting in Konstantino’s alleged breaches.
Judge Yvonne Gonzalez Rogers agreed in July 2015, ordering Konstantino to disgorge the $250,000 he received for licensing the Chocolate rights and a 2.85% royalty on sales of the device. Gonzalez Rogers also ordered Konstantino to cough up his roughly 15 million shares in QT Vascular, which were worth about $2 million at the time, and any profits gleaned from sales of the stock and any remuneration from consulting on the Chocolate device. The judge also awarded nearly $3.0 million in lost profits and another $17.1 million in future lost profits to AngioScore on future sales from 2014 through the 2nd quarter of 2019.
TriReme, QT Vascular and Quattro Vascular appealed to the U.S. Court of Appeals for the Federal Circuit as soon as the decision was finalized last October, arguing that 1 of the inventors of the patents, Dr. Chaim Lotan, assigned his interest in them to TriReme. In February the appeals court ruled that the lower court didn’t consider Lotan’s involvement carefully enough.