Tissue ablation technology developer Cardiosonic has received the CE Mark for its therapeutic intravascular ultrasound (TIVUS) ablative catheter device.
The Israeli firm's technology features a miniaturized ultrasonic transducer that's located at the tip of a flexible catheter and can emit ultrasonic waves that create controllable levels of heat for selective tissue ablation. The first application for the TIVUS catheter is renal denervation for the treatment of resistant hypertension, according to the vendor.
The TIVUS system has been evaluated in two multicenter clinical trials in Europe, Australia, and Israel. The TIVUS II trial enrolled 25 patients and has shown an average blood pressure reduction of 38 mm/hg following treatment.
Cardiosonic said it now intends to carry out the TIVUS III study, which will further assess the technology in a controlled manner.
Other future applications of the technology are expected to include treatment of pulmonary hypertension, chronic obstructive pulmonary disease (COPD), asthma, and atrial fibrillation, Cardiosonic said.