The 510(k) clearance covers lead placement for procedures involving His-bundle pacing, Fridley, Minn.-based Medtronic said. The catheter is designed for use with the SelectSecure MRI SureScan Model 3830 lead, which the company claims as the only pacing lead on the U.S. market approved for HBP.
“There is a growing trend of physicians interested in His-bundle pacing for certain patients as it leverages the native conduction system,” cardiac rhythm & heart failure medical affairs GM Dr. Rob Kowal said in prepared remarks. “Medtronic is pleased to continue to lead the industry with product innovations and training to support this emerging therapy technique.”
“Pacing at the bundle of His is a promising procedure with a growing body of clinical evidence,” added Dr. Pugazhendhi Vijayaraman of the Geisinger Heart Institute in Wilkes-Barre, Pa. “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.”