Pythagoras Medical's ConfidenHT System Receives CE Mark Approval

March 28, 2018—Pythagoras Medical announced that its ConfidenHT system has received European CE Mark approval to improve the efficacy of renal denervation procedures in the treatment of patients with resistant hypertension. The system provides real-time guidance to physicians by identifying ablation hot spots, which helps verify ablation effectiveness and identify nonresponder patients.

According to the company, the ConfidenHT system uses a mapping catheter that stimulates different areas of the renal artery and an algorithm that utilizes the physiologic response of this stimulation to create a map of hot spots for ablation. This technology also aims to reduce the risk of unnecessary ablation, which is an inherent part of the "blind" approach of current ablation technologies.

The system's multielectrode, over-the-wire catheter is compatible with an 8-F guiding catheter and 0.014-inch guidewire. The ConfidenHT mapping console has multichannel stimulation capabilities, and its proprietary algorithm uses multifactorial physiologic marker analysis. In addition, the console provides visualization of the artery's mapping results and hot spot locations on a 15-inch touchscreen display.

Professor Konstantinos Tsioufis, MD, served as Principal Investigator of the ConfidenHT clinical study, which evaluated the safety and performance of the device for diagnostic mapping of renal nerves.

In the company's announcement, Prof. Tsioufis commented, "This renal fibers stimulation project is, without a doubt, a very promising step in our endeavor to locate the 'sweet spots' where renal ablation will achieve the best results. Our preliminary experience seems to bring us closer to the goal of 'unblinding' the renal denervation procedure."