SAN CLEMENTE, Calif: ROX Medical, Inc., a privately held medical device company pioneering an innovative interventional vascular therapy for Uncontrolled Hypertension, announced today that the first patient was treated in the CONTROL HyperTeNsion (HTN)-2 clinical study, the Company's pivotal study to evaluate the safety and effectiveness of the ROX Coupler used to create an arterio-venous anastomosis in the iliac vessels, in patients with high blood pressure.
The CONTROL HTN-2 study is a large, multi-center trial that will include up to 30 study sites in the U.S. The first procedure was performed at Brookwood Baptist Health PRINCETON BAPTIST MEDICAL CENTER in Birmingham, Alabama by Dr. Farrell O. Mendelsohn, Physician Partner at Cardiology, P.C. "Our entire research team at Cardiology, P.C. 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," said Dr. Mendelsohn, the principal investigator for the research protocol.
Prior to CONTROL HTN-2, ROX Medical conducted a multi-center randomized trial in Europe. Patients treated with the ROX Coupler experienced a mean drop in blood pressure of 27 mmHg which was sustained out to 6 months. A manuscript has been recently accepted for publication confirming a significant and durable pressure drop at one year.
The ROX Coupler and FLOW procedure creates a passage between an artery and a vein in the upper thigh, which redirects a measured amount of arterial blood to the veins. This therapy is intended to reduce peripheral vascular resistance and add a compliant venous element to the arterial system through creation of a therapeutic arteriovenous anastomosis with the ROX Coupler.
Rodney Brenneman, Chief Executive Officer of ROX Medical, Inc., said, "Starting the ROX CONTROL HTN-2 study is a crucial milestone in our efforts to help the millions of patients living with uncontrolled high blood pressure manage their disease. We congratulate our colleagues at Brookwood Baptist Health PRINCETON BAPTIST MEDICAL CENTER on being the first to enroll in this important study."
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