A NOVEL DEVICE FOR NERVE IMAGING DURING ULTRASONOGRAPHIC RENAL DENERVATION PROCEDURE- PRELIMINARY RESULTS OF ANIMAL STUDY

Objective: Device-based therapies have been investigated as additional treatment options for uncontrolled hypertension. Of these, renal denervation (RDN) has the largest body of evidence for safety and efficacy. This technology was recently endorsed by ESH which recommends RDN for specific patient subsets. Ultrasound energy based denervation seems to be efficacious reducing daytime systolic blood pressure by 3mmHg on average compared to sham procedure. The main barrier for better results is the multiplicity of sympathetic nerves dispersed throughout the adventitia of either the main or accessory renal arteries, both proximally and distally. We aimed at examining a novel technique in which nerves are being imaged using a tiny ultrasound machinery embedded within the denervation catheter, just prior to US based denervation. We examined both safety and histologic efficacy in a preliminary animal study.Design and method: Healium Medical Ultrasound-based Echomplish™ RDN System was tested in a R&D animal setting in 40 pigs. A 6F Echomplish™ RDN novel catheter was used, enabling titratable low-power collimated ultrasound energy to treat with no tissue contact or need for vessel occlusion. Using its integrated ultrasound imaging, the areas intended for treatment were identified, allowing either circumferential or targeted denervation while avoiding unwanted regions in proximity to blood vessels. Multiple treatments were then applied along the artery to disrupt the hyperactive sympathetic nerves. Results: R&D animal studies were completed and demonstrated the ability to identify desired treatment regions and unwanted regions. No safety issues (premature animal death, hematoma, arterial rupture) were noted. Histologic section showed favorable response (figure 1). Conclusions: Dual-mode, low-power, ultrasound energy denervation incorporating ultrasonographic nerve imaging is a safe procedure, which enables direction of the catheter into wanted regions and accurate ablation of multiple nerves. Further study is conducted both in animals and in human hypertensive subjects in order to verify the efficacy of this novel technique.