Deflectable catheter system for His-bundle pacing procedures receives FDA clearance

Medtronic announced it has received FDA clearance for a deflectable catheter system used for His-bundle pacing procedures.

The catheter system (SelectSite C304-HIS) features a deflectable, out-of-plane curve to reach the His bundle and can enable enhanced range maneuverability, fixation and implant success for a wider range of patient anatomies, the company stated in a press release.

The device’s adjustable form helps accommodate and secure the pacing lead in more challenging anatomies, including patients with a large right atrium, according to the release.

“Pacing at the bundle of His is a promising procedure with a growing body of clinical evidence,” Pugazhendhi Vijayaraman, MD, the director of electrophysiology at Geisinger Heart Institute in Wilkes-Barre, Pennsylvania, said in a press release. “The C304-HIS catheter’s adjustable curve design should help implanters reach the His bundle fibers more easily and accommodate a variety of patient anatomies.”

The device facilitates placement of the cardiac pacing lead (SelectSecure MRI SureScan Model 3830, Medtronic), which is the only pacing lead approved for His-bundle pacing, according to the release.

“There is a growing trend of physicians interested in His-bundle pacing for certain patients as it leverages the native conduction system,” Rob Kowal, MD, PhD, chief medical officer, vice president of medical affairs in the cardiac rhythm and heart failure division at Medtronic, said in the release. “Medtronic is pleased to continue to lead the industry with product innovations and training to support this emerging therapy technique.”

Disclosures: Vijayaraman reports he received speaking and consultant fees and research grants from Medtronic; he is a consultant for Boston Scientific and Abbott; and he has a patent pending for a His delivery tool. Kowal is an employee of Medtronic.