Zug, Switzerland-based Renal Dynamics, which is owned by the Hobart Group, said the 1st patient in the trial was successfully treated at Novosibirsk, Russia’s Meshalkin State Research Institute of Circulation Pathology.
The Treat-HTN trial is designed to evaluate the Redy device’s safety and efficacy, Renal Dynamics said. Further details on the study were not released.
The 3rd-generation device uses a multi-electrode catheter designed to deliver a pre-set series of radiofrequency ablation impulses with a single positioning, using a universal 5Fr renal denervation catheter.
“The beginning of enrollment in the Treat-HTN clinical trial is a major milestone for the company as we continue to gain clinical experience with our system, and advances our efforts in bringing a better therapy to treat hypertension with a single intervention,” president & CEO Shawn Moaddeb said in prepared remarks.
“The ReDy System is an important advancement in treatment of uncontrolled hypertensive patients,” added Dr. Evgeny Pokushalov, whose team performed the 1st Redy procedure in the trial. “It has the potential to improve the overall effectiveness of renal denervation procedures by employing a novel multi-electrode single 5Fr catheter to treat a wide range of renal artery sizes and anatomies.”
“We are very encouraged and pleased to have the first patient enrolled in this study, which utilizes a proprietary quality-of-lesion algorithm to better enable more effective renal denervation procedures,” lead investigator Dr. Felix Mahfoud, of Homburg, Germany’s Saarland University Hospital, said in a statement.