ReCor Medical this week announced that its Paradise Ultrasound Renal Denervation System won FDA breakthrough device designation following positive results in a study.
The Palo Alto, Calif.-based company’s Paradise System is an investigational device that is designed to treat hypertensive patients who may not be sufficiently responsive or are tolerant to anti-hypertensive medical therapy. It is a catheter-based system that denervates the renal nerves with ultrasound energy to reduce blood pressure in hypertensive patients.
“ReCor is pleased the FDA granted breakthrough designation to the Paradise System,” VP of regulatory and medical affairs Leslie Coleman said in a news release. “ReCor believes that Paradise is truly innovative and has the potential to provide an important and innovative therapy option to hypertensive patients worldwide.”
The system won breakthrough device designation following positive results in the Radiance-HTN Trio study that evaluated the efficacy and safety of the Paradise System. In the study, patients 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). Once the patients were confirmed as having inadequately controlled hypertension with the medications, they were randomly assigned to Paradise System treatment or a placebo procedure.
ReCor’s trial met the primary efficacy endpoint of a greater reduction in daytime blood pressure between baseline and 2-month follow-up with the Paradise System, according to the company.
“ReCor is very pleased with the Trio outcomes, which demonstrate a clear Paradise treatment effect versus sham,” president and CEO Andrew Weiss said. “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.”