Medtronic’s next-gen renal denervation (RDN) catheter will be similar to the FDA-approved Symplicity Spyral pictured here. [Image courtesy of Medtronic]
“We’re going into the renal artery and doing renal denervation, and then going up into the [liver’s] hepatic artery and doing hepatic artery denervation because we have preclinical work that has shown us if you do those together, you further augment the reduction and the impact you can have on blood pressure,” Medtronic VP and RDN GM Jason Fontana said in an interview with Medical Design & Outsourcing.
And with Medtronic CEO and Chair Geoff Martha saying RDN “could be the biggest thing we ever do,” the next-gen catheter and procedure programs both have names befitting a space race.
Previously: What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains
Medtronic Coronary and Renal Denervation Operating Unit Global Marketing VP and Renal Denervation GM Jason Fontana [Photo courtesy of Medtronic]
He said Medtronic has already fully developed that next-generation catheter for wrist access (instead of the current generation’s access via the femoral artery) and could have it on the market in about 18 months.
“We’re leveraging our background on the coronary side to continue to bring that benefit of an easier, simpler procedure for patients and that quicker recovery,” he said. “We’re working our way through the manufacturing portion of it and the continued work with the FDA on it, but we’re feeling really good.”
The current Spyral catheter is something close to a one-size-fits-all device because it uses nitinol to self-expand within a patient’s renal arteries before ablating nerves in the vessel wall with radiofrequency (RF) energy. Fontana said the catheter should already be small enough for the next-gen procedure given the similar diameters of the renal and hepatic arteries. Similarly, the current RF generator should work for the procedure given appropriate adjustments to the RF energy delivery algorithm.
Medtronic’s Symplicity Spyral renal denervation (RDN) ablation catheter expands inside the renal arteries to apply energy that calms overactive nerves that help regulate blood pressure. [Illustration courtesy of Medtronic]
Medtronic is still studying the current system and procedure through its Global Symplicity Registry following about 2,000 patients outside the U.S. for three years after their procedures.
Medtronic is also following Symplicity patients through the Affirm Trial, which has broad population enrollment and is targeting underserved populations like Black patients, Latin Americans patients and older patients.
“Not only are we reinforcing the safety and efficacy profile we have, but then learning more about some of these subgroups and how we can continue to benefit them from a blood pressure reduction perspective, Fontana said. “That’s ongoing.”
These studies may address concerns from experts in medicine and statistical analysis on the Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee who said in 2023 that Symplicity Spyral’s risks outweighed its benefits.
2023: What Medtronic learned on its long road to RDN approval
Fontana also shared his thoughts on what defines minimally invasive medtech. You can read that here along with minimally invasive insights from other executives, engineers and physicians.
