Johnson & Johnson’s (NYSE:JNJ) Biosense Webster said yesterday it launched a European trial of its Qdot Micro novel radiofrequency ablation catheter designed for treating paroxysmal atrial fibrillation.
The Irvine, Calif.-based division said that the first patient in the trial has already been enrolled and treated by Aalst, Belgium’s OLV Hospital.
“The concept of high power, short duration ablation is novel and a potentially groundbreaking advancement for the industry. This new modality could result in improvements in clinical outcomes and procedural efficiencies and I look forward to further investigation,” Dr. Tom De Potter of OLV Hospital said in a prepared statement.
In the Qdot AF study, researchers will examine the delivery of high power, short duration ablation with the Qdot Micro at eight European centers, expecting to enroll a total of 50 patients.
The Qdot Micro is a next-gen cath designed to treat AF in catheter ablation procedures, and can deliver 90 watts of RF power in a four-second temperature-controlled catheter ablation session, the company said. The catheter features optimized temperature control and micro-electrode technology for efficient and consistent lesion creation, the company claims.
The steerable, multi-electrode catheter is only available for investigational use in Europe, BioSense Webster said.
“Qdot Micro will be a significant advancement in catheter ablation technology that has the potential to elevate the standard of care for atrial fibrillation treatment. Biosense Webster has a legacy of leadership in cardiac ablation and we are excited by the prospects this new device may provide for millions of patients,” J&J medical devices cardiovascular and specialty solutions grouop chair Shlomi Nachman said in a press release.
In January, BioSense Webster said that the first patient has been enrolled in an investigational device exemption trial for its WaveCrest system.