Recor Medical’s Paradise uRDN System Launched in United States

November 14, 2023—Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd., have announced the first commercial uses of Recor’s Paradise ultrasound renal denervation (uRDN) system for the treatment of hypertension.

On November 7, the company announced FDA approval of the Paradise system for renal denervation therapy in the United States. The Paradise uRDN system is now available as an adjunct treatment option for patients who have been unable to achieve blood pressure goals with standard lifestyle changes and oral medications.

The first commercial procedures were performed on November 7 by interventionist at four centers:

• Ajay J. Kirtane, MD, and Sahil A. Parikh, MD, at NewYork-Presbyterian/Columbia University Irving Medical Center in New York, New York
• Suhail Dohad, MD, and Raj Makkar, MD, at the Smidt Heart Institute at Cedars-Sinai in Los Angeles, California
• Vijay Iyer, MD, at Gates Vascular Institute in Buffalo, New York
• Aravinda Nanjundappa, MD, at the Cleveland Clinic in Cleveland, Ohio

According to Recor Medical, the Paradise uRDN system delivers two to three doses of 360º ultrasound energy—lasting 7 seconds each—through the main renal arteries to the surrounding nerves. The Paradise catheter features the company’s HydroCooling system, which circulates sterile water through the balloon during the procedure to help cool and protect the inner layers of the renal artery.

“It is truly remarkable that patients with difficult-to-control hypertension who are in need of other treatments beyond lifestyle modification and medications now have another option,” commented Dr. Kirtane in the company’s press release. “I just want to thank all of the collaborators and the many patients who committed along the years to the careful study of this technology, allowing this to come to fruition.”

Dr. Kirtane is a professor of medicine and Director of the Columbia Interventional Cardiovascular Care program at Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital.

Florian Rader, MD, Medical Director of the Hypertension Center of Excellence in the Smidt Heart Institute at Cedars-Sinai, added, “A new nonpharmacologic approach to lowering blood pressure in patients whose hypertension has been difficult to control with medications is a welcome addition to the current treatment options available to patients.”

Also, in Recor Medical’s press release, Dr. Iyer observed, “Catheter-based interventional strategies like that of the Paradise uRDN system have shown promising results in providing better blood pressure management for eligible patients with resistant hypertension. It is humbling to be part of this breakthrough technology because of the implications and huge potential it has to transform treatments for the entire spectrum of cardiovascular disease for a diverse set of patients in our region and beyond.”

Dr. Iyer is Director of the Structural Heart Program at Kaleida Health, an interventional cardiologist with Great Lakes Cardiovascular and Chief of the Division of Cardiology at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo.

Finally, Dr. Nanjundappa, an interventional cardiologist at Cleveland Clinic, stated, “This new renal denervation technology for a high-risk patient population—individuals with difficult to control hypertension—has been long awaited. We look forward to offering this procedure now to those that will likely derive benefit.”

Recor Medical’s Paradise uRDN system was tested through the RADIANCE Global Program of three prospectively powered and sham-controlled randomized controlled clinical trials: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-to-moderate hypertension. Each trial met its prespecified primary efficacy endpoint, showing statistically significant and clinically meaningful blood pressure reductions compared to a sham arm and favorable safety profiles, noted the company.