CardioFocus said today that it won CE Mark approval in the European Union for its HeartLight X3 endoscopic ablation system.
The Marlborough, Mass.-based company said that the HeartLight X3 is its third-generation endoscopic ablation system intended to perform pulmonary vein isolation procedures using laser energy to block the abnormal electrical pathways that cause atrial fibrillation.
The newly cleared HeartLight X3 uses direct tissue visualization, titratable laser energy and compliant balloon technology alongside a motor control system to allow for high-speed, circumferential lesion creation, CardioFocus said.
Approval of the device came based on results from the 60-patient pivotal trial of the device, which indicated very rapid pulmonary vein isolation and completion of all required ablations in less than 20 minutes, the company said.
“Our clinical results using the HeartLight X3 system have been outstanding, with unprecedented treatment speed and precise lesion creation. Based on our experience with the device, we feel confident that the HeartLight X3 system is poised to change the way AFib ablation is performed in Europe,” pivotal trial investigator Dr. Boris Schmidt of Frankfurt, Germany’s Cardioangiologisches Centrum Bethanien said in a press release.
CardioFocus said that it will begin a commercial launch in the region immediately, and that current HeartLight platform users can use the HeartLight X3 technology after an upgrade.
“We are eager to begin the commercialization of the breakthrough HeartLight X3 System in the European market. In partnership with our physician users, we are committed to continued innovation and delivering the best treatment modalities in the AFib ablation space,” prez & COO Burke Barrett said in a prepared statement.
Last July, CardioFocus said that it launched its HeartLight endoscopic ablation system in Japan in conjunction with its distribution partner JapanLifeline.
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