CardioFocus said today it launched a clinical trial of its next-generation HeartLight Excalibur balloon device designed for pulmonary vein isolation procedures.
The Marlborough, Mass.-based company said the next-gen device incorporates the balloon design from its HeartLight endoscopic ablation system alongside a new advanced feature set intended to improve speed and the magnitude of target tissue contact during procedures.
“The HeartLight Excalibur balloon conforms effectively to the range of anatomies that we encounter during PVI procedures. It is also very responsive, which may result in both better procedural efficiencies and potentially better patient outcomes. We are very pleased with the experience thus far,” Dr. Jan Petrů of the Electrophysiology Laboratory said in a press release.
The HeartLight Excalibur balloon includes the company’s proprietary dynamic response technology intended to make the balloon responsive to technique and differing amounts of pressure applied while optimizing vein contact.
“The new HeartLight Excalibur balloon is designed to capitalize on the existing features of our HeartLight system, which offers an accurate, consistent and controlled treatment option for AF patients whose heart arrhythmias are insufficiently controlled with medication. We are encouraged by the positive feedback we have received and the early clinical outcomes,” exec chair Paul LaViolette said in prepared remarks.
CardioFocus said said the device is undergoing a clinical trial in Europe “as part of a broader development program that seeks to confirm its design objectives.”
Last September, CardioFocus said it launched its HeartLight endoscopic ablation system in the US, touting that the 1st commercial procedure with the device had been performed at New York City’s Mount Sinai Hospital.
The HeartLight system allows electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural flexibility, a company spokesperson wrote to MassDevice.com. The device includes a compliant balloon to accommodate diverse PV anatomies and has a short learning curve to allow for quick adoption of the tech.