ReCor Medical has obtained CE mark approval for its Percutaneous Renal Denervation System (PARADISE) to treat resistant hypertension (HTN).
The PARADISE data from the F-I-M clinical trial demonstrated that systolic blood pressure was reduced by an average of 31 mm Hg in 7 patients at 60-day follow-up.
ReCor Medical CEO Mano Iyer said PARADISE is designed to offer a minimally invasive ultrasound therapy to resistant hypertension patients to help reduce their blood pressure.
"We are pleased with our First-In-Man clinical results as we prepare to introduce PARADISE in Europe,"Mano Iyer added.
PARADISE comprises a 6 French-compatible catheter with a cylindrical transducer that emits ultrasound energy uniformly all the way around the arterial wall while simultaneously cools the endothelium, which allows for a rapid and highly efficient renal denervation procedure.