FDA OKs ReCor Paradise™ Ultrasound Renal Denervation

ReCor Medical’s Paradise™ Ultrasound Renal Denervation System has received Breakthrough Device Designation from the U.S. FDA for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications.

Background

It’s a long time since we last wrote about renal denervation for hypertension… 2015 in fact. A year earlier the bombshell had been dropped by Medtronic’s Symplicity study that called the therapy into question and provoked the exit of some leading players. However, ReCor Medical, covered fairly frequently on our pages, clearly believed in itself. We last covered ReCor here, (April 2015!) as its clinical program since when the company has been acquired, gained CE mark for its system and undertaken studies that have cost many millions of currency units.

California’s ReCor Medical pioneered the minimally invasive use of ultrasound in renal denervation, and developed the Paradise® System, to treat patients with hypertension. Paradise remains an investigational device in the United States. It is approved for sales in the EU and bears a CE mark.

Fast forwarding to December 2020, hypertension remains one of the leading contributors to disease burden worldwide.

So what’s the latest from ReCor? Well, the Paradise system remains fundamentally the same catheter-based system designed to denervate the renal nerves with ultrasound energy.

The newly reported RADIANCE-HTN TRIO trial evaluated the efficacy and safety of the Paradise System to reduce blood pressure in hypertensive patients (n=136) wherein all subjects were placed on a single-pill combination-drug containing 3 anti-hypertension medications (a calcium-channel blocker, an angiotensin II-receptor blocker, and a diuretic).  After confirmation of inadequately controlled hypertension despite these medications, patients were then randomly assigned to Paradise System treatment or a sham (placebo) procedure.

The trial met its primary efficacy endpoint of a greater reduction in daytime blood pressure (Daytime ABPM) between baseline and 2-month follow-up with the Paradise System as compared with the sham procedure.

ReCor has now been granted designation for Paradise as a Breakthrough Device for the treatment of hypertensive patients who may not be sufficiently responsive, or are intolerant, to anti-hypertensive medical therapy. The FDA Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough medical technologies that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide ReCor with priority review and interactive communication during the premarket review process.

Company comments

President & CEO, Andrew M. Weiss said; “ReCor is very pleased with the TRIO outcomes, which demonstrate a clear Paradise treatment effect versus sham.

“ReCor believes that TRIO is a unique randomized, sham-controlled study in hypertension given the use of single pill triple medication to set a common baseline medication level in all study subjects, thus helping to establish that the Paradise RDN procedure can provide an additional clinical benefit to patients who are resistant to anti-hypertensive medications.”

Investigator comments

“The RADIANCE-HTN TRIO results very nicely complement the previously presented RADIANCE-HTN SOLO trial data, now demonstrating efficacy of renal denervation in a higher-risk cohort of patients with treatment-resistant hypertension,” commented co-principal investigator Ajay J. Kirtane MD, SM, Professor of Medicine at the Columbia University Vagelos College of Physicians and Surgeons. 

“On behalf of my co-principal investigator Professor Michel Azizi and the entire steering committee, I would like to thank the study patients, investigators, and coordinators from more than 50 study centers in 7 countries who gave so much of themselves in order to complete this rigorously conducted trial, especially in the throes of a pandemic. We eagerly look forward to fully presenting and publishing the data in the near future.”

Source: PR Newswire

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