The first patient was treated in the CONTROL hypertension (HTN)-2 clinical study, the Rox Medical’s pivotal study to evaluate the safety and effectiveness of the Rox Coupler used to create an arteriovenous anastomosis in the iliac vessels, in patients with high blood pressure.
A press release reports that the CONTROL HTN-2 study is a large, multicentre trial that will include up to 30 study sites in the USA. The first procedure was performed at Brookwood Baptist Health Princeton Baptist Medical Center in Birmingham, Alabama, USA, by Farrell O Mendelsohn.
Prior to CONTROL HTN-2, the press release notes, Rox Medical conducted a multicentre randomised trial in Europe. Patients treated with the Rox Coupler experienced a mean drop in blood pressure of 27mmHg which was sustained out to six 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.
Mendelsohn, the principal investigator for the research protocol, says: “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.”
Rodney Brenneman, chief executive officer of ROX Medical, says: “Sarting 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 Princepton Baptist Medical Center on being the first to enroll in this important study”.