Pivotal CONTROL HTN-2 Trial Begins for Rox Medical's Coupler Device
October 3, 2017—Rox Medical Inc. announced that the first patient was treated in the pivotal CONTROL Hypertension (HTN)-2 clinical study to evaluate the safety and effectiveness of the Rox Coupler, which is used to create an arteriovenous anastomosis in the iliac vessels in patients with high blood pressure. The large, multicenter CONTROL HTN-2 study will include up to 30 sites in the United States.
Principal investigator Farrell O. Mendelsohn, MD, a Physician Partner at Cardiology, PC, performed the study's first procedure at Brookwood Baptist Health's Princeton Baptist Medical Center in Birmingham, Alabama. Dr. Mendelsohn commented in the company's announcement, “Our entire research team at Cardiology, PC, is excited about implementing this research study for our patients, as the Rox Coupler technology may offer an alternative option to treat the global problem of uncontrolled hypertension.”
Before the CONTROL HTN-2 study, Rox Medical conducted a multicenter randomized trial in Europe. Patients treated with the Rox Coupler experienced a mean drop in blood pressure of 27 mm Hg, which was sustained out to 6 months. A manuscript has been recently accepted for publication confirming a significant and durable pressure drop at 1 year, noted the company.