ReCor Medical has announced updated data from the REDUCE first-in-man clinical study of its percutaneous renal denervation system (PARADISE), used for treating resistant hypertension, a major risk factor for cardiovascular disease.
The CE-marked PARADISE device features two components, an ultrasound energy delivery catheter and an automated, portable customised generator which controls pressure-in-balloon during automated inflation and deflation processes.
The 6 French-compatible catheter, with a cylindrical transducer of PARADISE, emits ultrasound energy circumferentially, allowing for efficient renal denervation procedures.
The updated data showed that in eight patients the systolic blood pressure was reduced by an average of 36mm Hg at 90-days follow-up, following treatment with the ultrasound transcatheter renal denervation system.
According to the scientific literature, just a 5mm Hg reduction in blood pressure results in a 14% decrease in stroke, a nine percent decrease in heart disease and a seven percent decrease in mortality rates.
PARADISE technology has the ability to uniformly denervate all the way around the arterial wall while simultaneously cooling the endothelium, to help enable a safe and consistent renal denervation procedure.
ReCor Medical CEO Mano Iyer said the system is designed to offer minimally invasive ultrasound therapy to resistant hypertension patients, to help reduce their blood pressure.
"These updated clinical data will boost our momentum as we get ready to launch PARADISE in Europe," Iyer added.
The company said the device is approved for sale in Europe, but it is not yet approved for sale or investigational use in the US.
ReCor is a private venture-backed, early-stage company developing therapeutic non-focused ultrasound catheter technology for performing renal denervation in patients with resistant hypertension.