Trial of Vessix V2 Denervation System (Vessix Vascular) underway for Hypertension patients

Patient treatments have begun in the multi-centre REDUCE-HTN renal denervation clinical study of the Vessix V2 Renal Denervation System, from Vessix Vascular, for patients with uncontrolled Hypertension. REDUCE-HTN is a non-randomized, prospective, single cohort, 64-patient study designed to validate the clinical performance of the Vessix V2 System for medication-resistant Hypertensive patients. Renal denervation is a new percutaneous catheter-based procedure that disrupts renal sympathetic nerves whose hyperactivity leads to abnormally high blood pressure. The renal denervation procedures were performed at Paracelsus Medical University in Salzburg, Austria by Prof. Uta Hoppe. All patients enrolled in the study have a baseline systolic blood pressure greater than 160 mm Hg despite being treated by at least three anti-hypertensive drugs. The REDUCE-HTN study will enroll patients at leading medical centres in Austria, Belgium, Germany, Switzerland, France, Netherlands and Australia. The study, which calls for patients to be followed for 24 months, will capture post-treatment office-based and ambulatory blood pressure measurements at various time points in accordance with internationally recognized guidelines. In addition to assessing the patient's clinical condition, the renal arteries of treated patients will be imaged at various time points post-treatment to confirm safety of the procedure.