RADIANCE CED will collect real-world data and build on the existing safety and efficacy evidence for the company’s Paradise uRDN system.
The first-of-its-kind Paradise ultrasound renal denervation (uRDN) technology denervates the sympathetic nerves surrounding the renal arteries. This lowers blood pressure by reducing the overactivity that can lead to hypertension.
Paradise delivers two to three doses of 360-degree ultrasound energy, lasting seven seconds each. The energy travels through each of the main renal arteries to the surrounding nerves. Its catheter features the Recor HydroCooling system that circulates sterile water during the procedure to protect the renal artery wall.
Recor Medical received the first FDA nod for its Paradise uRDN system in November 2023. Medtronic, the second company with such approval, won approval for the Symplicity Spyral system just weeks later. Both companies last month announced new CMS coverage that includes their RDN technologies.
Today, Recor CEO Lara Barghout posted on LinkedIn that CMS has now approved the company’s study, satisfying the Coverage with Evidence Determination (CED) requirement for the recent National Coverage Determination on renal denervation. She says that Medicare beneficiaries now have better access to Paradise as a result.
Recor’s approval from CMS came through today, while Medtronic also got the green light for its SPYRAL CARE real-world study last month.
“We are grateful to CMS for recognizing the value of the Paradise uRDN system as a treatment option for their beneficiaries with uncontrolled hypertension,” Barghout said.
