CE mark for TIVUS device


Cardiosonic has announced CE marking of its TIVUS (therapeutic intravascular ultrasound) ablative catheter device.

The core of the Cardiosonic’s technology is a miniaturised ultrasonic transducer, located at the tip of a flexible catheter, and capable of emitting ultrasonic waves which creates controllable levels of heat for selective tissue ablation.

The first application of the TIVUS catheter is renal denervation for the treatment of resistant hypertension.

According to Cardiosonic, animal testing has shown that the TIVUS non-focused ultrasonic energy penetrates the artery wall and causes nerve ablation at a depth range of 0.5mm to 10mm, enabling a more complete nerve ablation than Radio Frequency energy, which damages the vessel wall and penetrates half as deep as TIVUS.

The TIVUS system has been evaluated in two multicentre clinical trials in Europe, Australia and Israel. The TIVUS II trial enrolled 25 patients and has shown an average reduction in blood pressure versus baseline of 38 mmHg.

Cardiosonic now intends to carry out the TIVUS III study, which will further assess the TIVUS technology in a controlled manner.