ReDy receives CE clearance for third-generation Renal Denervation System

Renal Dynamics' (ReDy) third-generation Renal Denervation System received CE clearance and is now commercially available in Europe for treatment of Resistant Hypertension. The ReDy Renal Denervation System is based on a novel multi-electrode ablation technology that delivers a pre-determined RF ablation set with a single positioning.

The system includes a universal Renal Denervation Catheter and the SmartRF Generator that combines both bipolar and unipolar power with a proprietary algorithm and ensures complete lesion formation without unnecessary energy delivery.

"Obtaining CE clearance is a significant milestone," said ReDy's CEO and President, Mr. Shawn Moaddeb. "Preclinical results have indicated that the ReDy System is safe and effective. We now plan to initiate multi-center post market clinical studies to further support our existing data."

While renal denervation is gaining popularity with leading multi-nationals developing new devices and initiating new clinical trials in and outside the USA, the market still lacks a solution that addresses the basic limitations of the current technology, including difficulty in accessing the renal artery, inability to predict lesion formation and the need for multiple catheters per procedure.

"We are confident that our third-generation renal denervation system will increase efficiency, efficacy and patient comfort," said Professor Shlomo Ben-Haim, Founder of Renal Dynamics. "The ReDy System will make lesion formation more predictable, while using only one catheter per procedure and shortening procedure time."