Israel-based medtech developer Pythagoras Medical said today it won CE Mark approval in the European Union for its ConfidenHT nerve mapping system designed for use with renal denervation procedures.
The company, which was founded by med device investment group Rainbow Medical, said its ConfidenHT device is a novel system for patients with resistant hypertension that aims to improve the effectiveness of renal denervation procedures.
“This renal fibers stimulation project is, without a doubt, a very promising step in our endeavor to locate the “sweet-spots” where renal ablation produces will achieve the best results. Our preliminary experience seems to bring us closer to the goal of ‘unblinding’ the renal denervation procedure,” trial principal investigator Dr. Konstantinos Tsioufis said in a press release.
The system provides real-time guidance to physicians by identifying effective points for ablation, verifying ablation effectiveness and identifying non-responder patients.
The ConfidenHT system identifies high-efficacy points for denervation through the use of a mapping catheter which stimulates different areas of the renal artery and an algorithm which uses physiological response to the stimulation to create a map for such high-efficacy points.
The system features a multi-electrode, over-the-wire catheter and mapping console which features multi-channel stimulation and a proprietary algorithm using multi-factorial physiological market analysis.
“European CE Mark Approval provides significant validation of the ConfidenHT technology and its unique approach to improving the efficacy of RDN procedures and treating hypertension. Rainbow Medical will continue to focus on inventing and developing game-changing solutions to unmet medical needs,” Rainbow Medical CEO Efi Arazi said in a prepared statement.