New Renal Denervation System Hits The Spot And Delivers Therapy Says Medtronic

“Renal denervation is an important advancement in the management of treatment-resistant hypertension. 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.”

In short

Medtronic, Inc. has announced the successful completion of the first phase of the feasibility study of its next-generation renal denervation system featuring a simultaneously firing multi-electrode catheter and advanced radio-frequency (RF) generator. The first-in-man use of the device was performed in Australia and demonstrated 100% success in accessing the target and delivering therapeutic does of RF energy.

Background

Renal denervation therapy is a minimally invasive, catheter-based procedure intended to modulate the output of nerves that line the walls of the arteries leading to the kidneys. These nerves impact the sympathetic nervous system, which affects the major organs that are responsible for regulating blood pressure: the brain, the heart, the kidneys and the blood vessels.

 Despite not yet being available in the U.S., 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. Indeed the adoption of renal denervation outside the U.S. has been noteworthy as a case study in the differing approaches across the pond to the adoption of a new technology. The single-electrode Symplicity system’s catheter and proprietary generator and algorithms were really the first out there and as such it was always likely that a next generation device would emerge either through Medtronic or its competitors.

And so it seems is the case. Medtronic’s “next-generation” renal denervation system builds upon Medtronic’s experience with the Symplicity™ system for treatment-resistant hypertension. Somewhat like the St.Jude EnligHTN™ system it 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, highly conformable with a non-occluding design, according to the company.

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, all comparative weaknesses of the current system which is said to be harder to handle than some of the newer offerings and with its single electrode take longer to deliver its therapeutic energy dose.

Medtronic’s new 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.

So the news then is that a total of nine patients were treated in Australia with a 100 percent acute success rate in accessing the vessels and delivering therapy.

Physician comments 

“Renal denervation is an important advancement in the management of treatment-resistant hypertension,” said Robert Whitbourn, M.D., 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.”

Company comments

“We look forward to moving forward with our clinical evaluation of this next-generation system that aims to augment our portfolio by offering more sophisticated features that should benefit both physicians and patients,” said Sean Salmon, Senior Vice President and President, Coronary & Renal Denervation, Medtronic. “This feasibility study represents Medtronic’s commitment to providing physicians with a broader range of solutions for performing renal denervation and to collaborating with physician partners in the ongoing evaluation of this groundbreaking therapy.”

Regulatory status

The FDA granted Medtronic approval for the protocol for SYMPLICITY HTN-3, the company’s U.S. clinical trial of the single-electrode Symplicity renal denervation system for treatment-resistant hypertension, in August 2011.

The investigational next-generation Symplicity™ system is not yet commercially available anywhere in the world.