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Medtronic receives CE Mark for catheter system and cardiac pacing lead

Bundle of His helps improve and preserve heart function and reduce heart failure-related hospitalisations in patients who require frequent ventricular pacing therapy

Medtronic has announced CE (Conformité Européenne) Mark for a system that delivers electrical pacing at a different location, called the bundle of His, which may help improve and preserve heart function and reduce heart failure-related hospitalisations in patients who require frequent ventricular pacing therapy.

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CE Mark was granted for the Medtronic SelectSite C304-HIS deflectable catheter system and CE Mark labelling expansion for the Medtronic SelectSecure MRI SureScan Model 3830 cardiac pacing lead for use in His-bundle pacing procedures.

Permanent His-bundle pacing is an alternative to traditional pacing in the right ventricle, harnessing the heart’s native His-Purkinje system. In recent years, clinical studies have explored the His bundle as an alternate location within the heart to position a pacemaker lead (wire) through which to deliver electrical impulses.

“This catheter promises to be an exciting advance and is expected to make implantation of the Medtronic SelectSecure lead on the His bundle more straightforward,” said Zachary Whinnett, Consultant Cardiologist, Imperial College, London. “This new tool is an important step in making His-bundle pacing accessible to more patients.”

The SelectSite C304-HIS deflectable catheter system features a deflectable, out-of-plane curve designed to reach the bundle of His. Its adjustable form helps accommodate and secure the pacing lead in more challenging anatomies, including patients with a large right atrium. The C304-HIS expands the reach beyond that of the currently available C315HIS catheter, allowing for this therapy to be successful in more patients.

“We understand the importance of continually evolving tools to be able to reach the bundle of His in more patient anatomies,” said Rob Kowal, Chief Medical Officer of the Cardiac Rhythm Management business, which is part of the cardiovascular portfolio at Medtronic. “The C304-HIS launch builds upon our decade-long commitment to creating innovative solutions for His-bundle pacing.”

Following the completion of benchmark testing and real-world clinical analysis, Medtronic also recently received CE Mark labelling expansion for the Medtronic SelectSecure MRI SureScan Model 3830 cardiac pacing lead to be placed at or near the bundle of His. It is the only pacing lead CE Mark-approved for His-bundle pacing.

The steroid-eluting, catheter delivered bipolar SelectSecure SureScan MRI model 3830 lead (lengths of 59, 69 and 74 cm) is attached to a single or dual-chamber pacemaker, and is approved for pacing and sensing in the right atrium, right ventricle, or at the bundle of His as an alternative to right ventricular pacing. The SelectSecure SureScan MRI model 3830 lead can be delivered to the bundle of His with either the C315HIS or C304-HIS catheters.

In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

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