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."
Hypertension is a chronic medical condition in which the blood pressure in the arteries is elevated. Blood pressure is expressed by two measurements, the systolic and diastolic pressures, which are the maximum and minimum pressures, respectively, in the arterial system.
Normal blood pressure at rest is within the range of 100-140 mmHg systolic and 60-90 mmHg diastolic. Hypertension is present if the blood pressure is persistently at or above 140/90 mmHg for adults. Sustained hypertension over time is a major risk factor for heart disease, coronary artery disease, stroke, aortic aneurysm, peripheral artery disease and chronic kidney disease. Hypertension affects over 1 billion people worldwide.
Renal Denervation is an interventional approach to treat high blood pressure. The minimally-invasive, endovascular-catheter-based procedure uses radiofrequency or ultrasound ablation to treat resistant hypertension. Nerves in the wall of the renal artery are ablated by applying radiofrequency pulses to the renal arteries.