ReCor Medical today applauded updated and expanded recommendations for managing arterial hypertension overseas.
The European Hypertension Society (ESH) this month issued updated guidelines on the role of renal denervation in the hypertension care pathway. It announced the guidelines at the ESH 32nd Annual Meeting and simultaneously published them in the Journal of Hypertension.
These new guidelines serve as a resource for the latest scientific evidence in hypertension treatment. They include recommendations on the use of renal denervation, for which ReCor develops the Paradise system.
Last week, Medtronic issued a similar statement to express its excitement with the new guidelines.
“The ESH guidelines support the experience of European clinicians who are already using the Paradise Ultrasound RDN System for some patients who need an additional treatment option to achieve meaningful reductions in blood pressure,” 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 and bringing the benefits of ultrasound RDN to patients who need it. In the coming months, we will work with the FDA to complete their review of our PMA seeking approval of ultrasound RDN in the U.S.”
How the guidelines benefit ReCor Medical
The guidelines consider renal denervation an additional treatment for patients with resistant hypertension on three or more antihypertensive medications. It also offers a treatment option for patients with uncontrolled hypertension despite antihypertensive drug combination therapy. Finally, renal denervation’s use extends to instances in which a patient’s drug treatment elicits serious side effects and poor quality of life.
Michel Azizi serves as a professor of medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France. Azizi called the guidelines “a significant milestone for the field of arterial hypertension management.”
ReCor completed three global, independently powered, sham-controlled randomized clinical trials for the Paradise system. The trials for the ultrasound renal denervation system treated more than 500 patients with uncontrolled hypertension. RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II all met primary efficacy endpoints. They demonstrated blood pressure reduction with positive safety outcomes.
Paradise already has CE mark for treating hypertension in Europe. It remains investigational in the U.S. and Japan.
The company most recently shared positive data from RADIANCE II in February. ReCor submitted a premarket approval application to the FDA for Paradise in November 2022. An FDA panel intends to meet next month to make recommendations and vote on devices for reducing blood pressure in patients with hypertension.