ConfidenHT System receives CE Mark
Pythagoras Medical, a cutting edge medical device company established by Rainbow Medical, has announced that its ConfidenHT System has received a European CE Mark. ConfidenHT is a novel system for patients with resistant hypertension, which improves the efficacy of renal denervation (RDN) procedures. ConfidenHT provides real-time guidance to physicians by identifying ablation "hot spots", verifying ablation effectiveness and identifying non-responder patients.
About 31% of adults worldwide have hypertension. Resistant hypertension, estimated to appear in 9-18% of hypertensive patients, significantly increases the risk of heart disease, stroke, and kidney disease. One of the mechanisms that controls blood pressure is a neurological signal sent from the kidneys to the brain.
Eliminating this neurological link by ablating or "denervating" of the nerve through an RDN procedure can restore normal blood pressure in many patients. Recent RDN studies demonstrate that up to 40% of patients treated with such procedures showed no signs of improvement due to inaccurate nerve targeting.
This occurs due to the blind nature of current RDN technologies, which do not provide feedback to the physician. ConfidenHT is unique in its ability to identify hot-spots for denervation and to verify the effectiveness of the procedure.
This is achieved by a mapping catheter that stimulates different areas of the renal artery and an algorithm that uses the physiological response of this stimulation to create a map of hot-spots for ablation. This technology also reduces the risk factor associated with unnecessary ablation, which is an inherent part of the "blind" approach of current ablation technologies.
According to Professor Konstantinos Tsioufis, Principal Investigator and President of the ESH, "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."
The ConfidenHT Catheter is a multi-electrode, over-the-wire catheter compatible with an 8F guiding catheter and 0.014" guide wire. The ConfidenHT' mapping console features multi-channel stimulation capabilities, and its proprietary algorithm uses multi-factorial physiological marker analysis. In addition, the console provides visualisation of the artery's mapping results and hot-spot locations on a 15" touchscreen display.
"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," said Efi Cohen Arazi, CEO of the Rainbow Medical group. "Rainbow Medical will continue to focus on inventing and developing game-changing solutions to unmet medical needs."