Israel-based medical device company Cardiosonic has obtained CE Mark approval for its TIVUS (therapeutic intravascular ultrasound) ablative catheter device.
The TIVUS catheter is featured with a miniaturized ultrasonic transducer that delivers directional ultrasound energy. Located at the tip of a flexible catheter, the ultrasonic transducer emits ultrasonic waves that create controllable levels of heat for selective tissue ablation.
According to Cardiosonic, first application of the TIVUS catheter is renal denervation for the treatment of resistant hypertension.
In pre-clincal trials, the TIVUS system has showed that the non-focused ultrasonic energy produced by the device penetrates though the artery wall and causes nerve ablation at a depth range of 0.5mm to 10mm.
The TIVUS system has enabled a more complete nerve ablation than radio frequency energy. Radio frequency energy damages the vessel wall and penetrates half as deep as TIVUS.
Safety and performance of the TIVUS system was assessed in two clinical trials conducted in Europe, Australia and Israel. The TIVUS II trial, which enrolled 25 patients, has demonstrated average reduction in blood pressure versus baseline of 38mmHg.
Cardiosonic CEO Benny Dilmoney said: "The impressive drop in blood pressure is due to a high level of renal nerves ablation, made possible by the fact that ultrasonic heat waves penetrate much deeper into the artery tissues than any other ablation methods in use, mainly RF."
The company plans to conduct TIVUS III study that will further evaluate the TIVUS technology in a controlled manner.
Dilmoney expressed confidence that the results obtained in the TIVUS II study will be replicated in the planned follow-up TIVUS III study.
TIVUS technology’s other applications include the treatment of pulmonary hypertension, chronic obstructive pulmonary disease, asthma and atrial fibrillation. Cardiosonic completed very encouraging preliminary animal work in all of these areas.
Image: Cardiosonic’s TIVUS generator and catheter. Photo: Courtesy of Business Wire/Cardiosonic Ltd.