CE Mark For PARADISE™ Ultrasound Transcatheter Renal Denervation System

“This degree of blood pressure reduction has significant health benefits for patients.”

In short

Last week we announced the start of two clinical initiatives evaluating the broader, real-world clinical use of Medtronic’s Symplicity™ renal denervation system across multiple conditions. Now German company ReCor Medical, has announced today that it  has received the CE mark for its PARADISE (Percutaneous Renal Denervation System) designed to treat patients with ‘resistant’ hypertension (“HTN”), a major risk factor for cardiovascular disease. In contrast to Medtronic’s and indeed St Jude‘s Radiofrequency-based systems, PARADISE utilises ultrasound energy to achieve denervation of the renal sympathetic nervous system, with additional safeguards against vessel wall damage including cooling fluid in its positioning balloon.

According to the company release, “PARADISE is designed to offer a minimally invasive ultrasound therapy to resistant hypertension patients to help reduce their blood pressure”

Background

PARADISE includes a 6 French-compatible catheter with a cylindrical transducer that emits ultrasound energy circumferentially, allowing for a rapid and highly efficient renal denervation procedure. The advantage of PARADISE is its ability to uniformly denervate all the way around the arterial wall while simultaneously cooling the endothelium, to help enable a safe, consistent, and fast renal denervation procedure.

The First-in-man clinical data for PARADISE were reported at the “TRenD 2012” transcatheter renal denervation scientific meeting by cardiologist Thomas A. Mabin, M.D., Vergelegen Medi-Clinic, South Africa. The PARADISE data showed that systolic blood pressure was reduced by an average of 31 mm Hg in 7 patients at 60-day follow-up.

Company comments

“PARADISE is designed to offer a minimally invasive ultrasound therapy to resistant hypertension patients to help reduce their blood pressure,” said Mano Iyer, CEO, ReCor Medical. “We are extremely pleased with our First-In-Man clinical results as we prepare to launch PARADISE in Europe.”

Clinician comments

“The initial results with PARADISE are impressive,” added Professor Marc Sapoval, Hôpital Européen Georges-Pompidou, Paris, who is a member of ReCor Medical’s Medical Advisory Board. “This degree of blood pressure reduction has significant health benefits for patients.”

Regulatory status

PARADISE™ is approved for sale in Europe; it is not approved for sale or investigational use in the United States

Source: ReCor Medical