Medtronic completes first-in-man study for investigational next-generation multi-electrode renal denervation system


On 3 September, Medtronic announced that it has successfully completed the first phase of the feasibility study of its next generation renal denervation system featuring a simultaneously firing multi-electrode catheter and advanced radiofrequency (RF) generator. 

A total of nine patients were treated with a 100% acute success rate in accessing the vessels and delivering therapy. The investigational next-generation Symplicity system is not commercially available anywhere in the world.

Medtronic’s single-electrode Symplicity renal denervation system has been used for five years to treat more than 5,000 patients with treatment-resistant hypertension worldwide. The single-electrode Symplicity system’s catheter and proprietary generator and algorithms were carefully and specifically developed through years of clinical experience to enhance the safety and effectiveness of the renal denervation procedure.

The single-electrode Symplicity renal denervation system is only available in the United States for investigational use.

The next-generation system will feature a new four electrode catheter that delivers RF energy simultaneously and is designed to significantly reduce ablation time during renal denervation procedures. The new catheter will be 6 Fr compatible. This new design is intended to provide ease of deliverability and consistency of RF energy application, while also enabling the treatment of a wide range of renal anatomies.

The next-generation Medtronic renal denervation system also incorporates a new generator with an improved user interface. The new generator will leverage the benefits of Medtronic’s proven and proprietary Symplicity treatment algorithm with its built-in safety features and will be compatible with both the single-electrode Symplicity catheter and the next-generation multi-electrode catheter.

“Renal denervation is an important advancement in the management of treatment resistant hypertension,” said Robert Whitbourn, professor/director of the Cardiac Cath Labs & Coronary Intervention, St Vincent’s Hospital, Melbourne, Australia and principal investigator of the study. “This next-generation system has several innovative features that could take this procedure to the next level by providing the flexibility to treat a wide range of different anatomies, as well as helping to improve efficiency of care through significantly reduced ablation and procedure times.”