QT Vascular said today that it launched the U.S. pivotal trial for its Chocolate Touch drug-coated peripheral balloon in the hopes of winning FDA approval. The device won CE Mark clearance in September 2015.
The trial is slated to compare the safety and effectiveness of the Chocolate Touch balloon with Bard‘s(NYSE:BCR) Lutonix drug-coated balloon catheter. The company said it plans to evaluate non-inferiority and superiority of its DCB over Bard’s device.
QT Vascular plans to enroll 510 patients and complete an interim analysis after 75% of the participants finish a 12-month follow-up. The study’s primary efficacy endpoint is primary patency in the absence of bailout stenting, according to the Singapore-based company.
“I’m delighted to start enrollment in this important study,” co-principal investigator Thomas Zeller said in prepared remarks. “We believe that the unique properties of Chocolate, namely larger lumen with less dissections and bailout stenting, make this a differentiated DCB option. This head-to-head study against Lutonix DCB is set up to demonstrate this point.”
“We are excited about the first patient enrollment in this worldwide study evaluating Chocolate, a second-generation DCB,” co-principal investigator Mehdi Shishehbor added. “This first of a kind trial will help guide physicians as they choose the best DCB for their patients.”
In the Chocolate Touch Endure study, 12-month outcomes included a 1.4% incidence of bailout stenting.
“DCBs are demonstrating significant US sales despite limitations and lack of differentiation,” CEO Eitan Konstantino said. “The Chocolate platform is different and we are encouraged by the clinical results to date.”