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Pacing lead receives expanded labeling from FDA
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Medtronic announced that a cardiac pacing lead has received labeling expansion from the FDA for patients who require His-bundle pacing.
The pacing lead (SelectSecure MRI SureScan Model 3830, Medtronic) is the only approved device on the market for His-bundle pacing, according to a press release from the company.
“There is growing interest among some physicians in His-bundle pacing as an alternative to right ventricular pacing, and we are pleased to offer the SelectSecure MRI lead for those who would like the option of this pacing approach for appropriate patients,” Rob Kowal, MD, PhD, vice president and chief medical officer of the cardiac rhythm and heart failure division of the cardiac and vascular group at Medtronic, said in the press release.
The lead, which is both steroid eluting and bipolar, is available in lengths of 59 cm, 69 cm and 74 cm and attaches to either a single or dual chamber pacemaker, according to the release. It has been approved for sensing and pacing in the right ventricle, atrium or at the bundle of His.
A delivery catheter (C315HIS, Medtronic) can be used to easily place the lead at or near the bundle of His, and through this method of pacing, the heart is able to control its native His-Purkinje system, according to the press release.
Disclosure: Kowal is an employee of Medtronic.
Editor's Note: This article was updated on August 1, 2018 to correct the model number of the lead. The Editors regret the error.