Medtronic Completes First-In-Man Study for Multi-Electrode Symplicity Renal Denervation System

October 3, 2012—Medtronic, Inc. (Minneapolis, MN) announced completion of the first phase of the feasibility study of its next-generation Symplicity renal denervation system. Investigators treated nine patients with a 100% acute success rate in accessing the vessels and delivering therapy.

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

Additionally, the next-generation system incorporates a new generator with an improved user interface, which will leverage the benefits of the Symplicity treatment algorithm with its built-in safety features and be compatible with both the single-electrode Symplicity catheter and the next-generation multi-electrode catheter, stated Medtronic.

“Renal denervation is an important advancement in the management of treatment-resistant hypertension,” commented Principal Investigator Robert Whitbourn, MD, of St. Vincent's Hospital in Melbourne, Australia. “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.”

According to Medtronic, the single-electrode Symplicity renal denervation system has been used for 5 years to treat more than 5,000 patients with treatment-resistant hypertension worldwide. The company stated that it developed the system's catheter, generator, and algorithms 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 investigational next-generation multi-electrode Symplicity renal denervation system is not commercially available anywhere in the world, the company advised.