Renal Dynamics’ (ReDy) third-generation Renal Denervation System has been granted CE mark approval for the treatment of resistant hypertension and is now commercially available on the European market.
Based on a novel multi-ablation technology, ReDy claim that its renal denervation system delivers a pre-determined RF ablation with a single positioning. As well as a universal renal denervation catheter, the system uses the SmartRF generator, which combines both bipolar and unipolar power with a proprietary algorithm, designed to ensure complete lesion formation without unnecessary delivery of energy.
ReDy’s CEO and president, Shawn Moaddeb, says, “Preclinical results have indicated that the ReDy System is safe and effective. We now plan to initiate multi-centre 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,” says 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.”