Medical technology company Medtronic has secured US Food and Drug Administration (FDA) clearance and for the SelectSite C304-HIS deflectable catheter system for use in procedures involving His-bundle pacing (HBP).
Medtronic has also announced the commercial launch of its new catheter system SelectSite C304-HIS, following the FDA clearance.
The medical company said that its new SelectSite C304-HIS deflectable catheter system features a deflectable, out-of-plane curve to reach the bundle of His and is designed to provide extended range manoeuvrability, fixation and implant success for a broad range of patient anatomies.
In addition, the adjustable form of the device helps accommodate and secure the pacing lead in widely challenging anatomies, including patients with a large right atrium.
Geisinger Heart Institute electrophysiology director Pugazhendhi Vijayaraman said: “Pacing at the bundle of His is a promising procedure with a growing body of clinical evidence. 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.”
Medtronic said that its new catheter system allows placement of its SelectSecure MRI, SureScan Model 3830 cardiac pacing lead, which marks the only pacing lead approved for HBP available in the US market.
As a physiologic alternative to the right ventricular pacing, His-bundle pacing involves placing a pacing lead at or near the bundle of His, using the heart’s native His-Purkinje conduction system to restore the heart’s normal rhythm.
Medtronic cardiac and vascular group vice president Rob Kowal said: “There is a growing trend of physicians interested in His-bundle pacing for certain patients as it leverages the native conduction system. Medtronic is pleased to continue to lead the industry with product innovations and training to support this emerging therapy technique.”
Recently, Medtronic entered into the guide extension catheter market by launching its FDA cleared and CE marked Telescope Guide Extension Catheter, to enable smooth delivery of coronary stents and balloons.
Headquartered in Dublin, Ireland, Medtronic is one of the world’s largest medical technology, services and solutions companies. Employing more than 90,000 people worldwide, the company serves physicians, hospitals and patients in more than 150 countries.