Vessix Vascular has initiated patient treatment using its V2 renal denervation system in the international multicentre REDUCE-HTN renal denervation clinical study for uncontrolled hypertension.
The 64-patient non-randomised prospective single cohort REDUCE-HTN clinical study is intended to validate clinical performances of the Vessix V2 renal denervation system, designed specifically for medication-resistant hypertensive patients.
The renal denervation system is an over-the-wire balloon catheter with an array of RadioFrequency (RF) electrodes designed to deliver a modest dose of RF energy to disrupt the renal nerves, located in the adventitia that surround the renal artery.
The ten-centre REDUCE-HTN study will enrol patients with a baseline systolic blood pressure greater than 160mm Hg at medical centres in Austria, Belgium, Germany, Switzerland, France, Netherlands and Australia.
The patented RF balloon catheter integrates with a bipolar RF generator specifically designed and optimised for the renal denervation clinical application. The V2 balloon catheter occludes blood flow to the renal artery during the 30-second RF therapy delivery, allowing for a directed and highly controlled flow of energy to the target nerves.
The study evaluated the patient's clinical condition and imaged the renal arteries of treated patients at various time points post-treatment to confirm the safety of the procedure.
Paracelsus Medical University in Salzburg, Austria, professor Uta Hoppe said the catheter is easy to use and quite efficient in terms of therapy time.
"Moreover, the patient required modest amounts of intravenous anxiolytics and narcotics since the therapy was delivered in a matter of seconds," Hoppe added.
"We will, of course, closely monitor the patients and are optimistic that the Vessix approach will produce a measurable reduction in blood pressure."
Vessix Vascular CEO Raymond Cohen said the company looks forward to working with the first class clinical investigators and institutions participating in the study and sharing the clinical results in the coming months.
Treatment with the RF improves the efficiency of the denervation procedure and provides safety benefits to the clinician conducting the procedure and the patient in terms of less use of contrast dye and lower exposure to radiation. Vessix is a privately held pre-revenue stage company developing novel radiofrequency balloon catheter technology.