The ESC upgraded renal denervation to a Class IIb recommendation for patients with uncontrolled and resistant hypertension. Officials presented the new guidelines at the ESC Congress on Aug. 30 in London.
Medtronic said the new guidelines outline patient selection criteria includes all adult patients with uncontrolled and resistant hypertension. They place emphasis on patients with high cardiovascular risk who remain uncontrolled. These patients express a preference to undergo RDN in a tailored, shared decision-making process.
According to Medtronic, the new guidelines are the second set from Europe. These follow ESH guidelines and consensus statements from leading countries. The medtech giant says these guidelines underscore the role of its Symplicity Spyral RDN system.
Medtronic received a landmark approval for the system in November 2023. Approval made Medtronic the second company with such approval, following Recor Medical’s nod earlier that month.
Symplicity Spyral delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure. These nerves can become overactive and contribute to high blood pressure. Medtronic’s RDN system holds approval for commercial use in more than 75 countries.
“Uncontrolled hypertension has a devastating impact around the world, which makes us further emboldened to provide innovative solutions like the Symplicity blood pressure procedure to patients who could potentially benefit,” said Jason Weidman, SVP and president of the Coronary and Renal Denervation business at Medtronic. “These updated guidelines are also important for physicians as they reinforce RDN as an additional hypertension care option for those patients who may not respond adequately to lifestyle changes and medication management.”
Recor Medical joins Medtronic with praise for guidelines
On Sept. 3, Recor Medical announced its own endorsement for the updated recommendations.
Dr. Michael Böhm, cardiologist and clinical director of Internal Medicine III at Saarland University Hospital in Homburg, Germany, said in a news release that the recommendation follows the demonstration of the efficacy and safety of RDN in randomized sham-controlled trials.
I am very pleased that RDN is now recommended in the ESC Guidelines as a treatment option for refractory and non-adherent patients,” Böhm said. “It is now up to us to implement these guidelines in everyday clinical practice and provide patients with the services they need.”
Recor said it completed three global, independently powered, sham-controlled randomized trials for its Paradise uRDN system. All studies met their prespecified primary efficacy endpoints of blood pressure reduction with positive safety outcomes.
The company says the growing support for RDN “provides further momentum for the ongoing adoption of Recor’s hypertension therapy.”
“We are delighted that the ESC guidelines recommend the consideration of renal denervation as an effective option to treat uncontrolled hypertension,” said Recor President and CEO Lara Barghout. “The urgent global need to address the burden of uncontrolled hypertension remains, and we’re committed to revolutionizing the way hypertension is treated by bringing the benefits of Paradise ultrasound RDN to patients who need it.”
This article originally ran on Aug. 31 following an announcement by Medtronic. It was updated on Sept. 3 to include commentary from Recor Medical.
