Twelve-Month CONTROL HTN Data Published for Rox Coupler Device

October 30, 2017—Rox Medical Inc. announced that the 12-month outcomes of the ROX CONTROL HTN study were published by Melvin D. Lobo, MD, et al online ahead of print in Hypertension.

According to the company, the multicenter randomized controlled ROX CONTROL HTN trial enrolled patients with uncontrolled hypertension. At the 12-month follow-up, patients treated with the Rox Coupler device had a sustained mean reduction of 25 mm Hg in in-office systolic blood pressure and a reduction of 13 mm Hg in 24-hour ambulatory systolic blood pressure versus baseline.

These results are consistent with 6-month clinical outcomes previously reported in The Lancet, which reported a mean decrease of 27 and 13 mm Hg in in-office and ambulatory pressures, respectively, advised Rox Medical.

In the company's press release, Dr. Lobo commented, “The magnitude of ambulatory blood pressure reduction at 12 months is striking and establishes a genuine, significant, and durable antihypertensive effect. These compelling clinical benefits suggest that the Rox Coupler has the potential to be a major advance in the treatment of patients suffering from uncontrolled hypertension.”

The 12-month CONTROL HTN data will be included in an oral presentation on the Rox Coupler by Krishna Rocha-Singh, MD, at the TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 30 to November 2 in Denver, Colorado. Dr. Rocha-Singh is also the principal investigator for the CONTROL HTN-2 clinical trial.

Rox Medical is currently enrolling the CONTROL HTN-2 clinical study, which is a randomized, sham-controlled pivotal trial designed 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.