Recor Medical announced that the FDA approved its Paradise ultrasound renal denervation (RDN) system for treating hypertension.
The long-awaited approval for the Otsuka Medical Devices portfolio company allows for the use of Paradise as an adjunctive treatment option when lifestyle changes and medications fail to adequately control a patient’s blood pressure.
Paradise had looked the most likely system to win approval in the race for the first FDA nod to use RDN to treat hypertension. An FDA panel voted in favor of FDA approving Paradise uRDN system in August. The same panel voted against recommending Recor’s closest competition, Medtronic’s Symplicity Spyral, a day later.
Recor presented a combined analysis of six-month follow-up data at last month’s Transcatheter Cardiovascular Therapeutics (TCT) symposium. The analysis demonstrated maintained blood pressure (BP) reduction following treatment with uRDN compared to sham. It also saw fewer antihypertensive treatments added in the treatment group. Paradise also met both primary safety and efficacy endpoints in the RADIANCE II trial, with results shared in February. RADIANCE II notably saw zero major adverse events.
“Recor is leading the way in bringing an innovative solution to clinicians and their patients struggling to control blood pressure. This FDA approval is the culmination of years of technical research and rigorous clinical studies,” said Lara Barghout, president and CEO of Recor Medical. “We are grateful to the patients who participated in the studies and to the clinical trial investigator teams whose diligence and dedication made FDA approval possible. We look forward to making this technology available to physicians and their patients nationwide.”
More about Recor Medical and the Paradise uRDN system
The first-of-its-kind Paradise 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 began developing and testing Paradise for treating hypertension in 2009. Its RADIANCE global program evaluated more than 500 patients with uncontrolled hypertension. The system already holds CE mark and remains investigational in Japan.
“Approval of the Paradise Ultrasound RDN system marks an important milestone for the company and provides a new adjunctive treatment option for hypertension which remains inadequately controlled despite conventional therapies,” said Noriko Tojo, president and representative director of Otsuka Medical Devices and executive director of Otsuka Holdings Co., Ltd. “We are excited for patients and their healthcare professionals to have access to this technology to assist in managing hypertension and improving outcomes.”
Will Medtronic be next?
All eyes now move toward Medtronic, which has an outstanding FDA submission for its Symplicity Spyral for the same indication.
Despite the negative vote from the FDA panel, there remains a pathway for premarket approval (PMA). A company spokesperson shared a statement with MassDevice in response to the news of Recor’s approval:
“We congratulate ReCor on the FDA approval of their Paradise RDN system, which marks a significant milestone in the field of RDN and for patients and physicians.
“Medtronic welcomes innovation in the field of renal denervation as it provides further validation of the therapy as a complementary treatment option in reducing blood pressure for patients, in addition to medications and lifestyle changes.
“Medtronic remains confident in the therapy and continues to have productive discussions with FDA regarding our PMA submission. We look forward to hearing soon from FDA regarding our submission for the Symplicity Spyral renal denervation (RDN) system.”