Twelve-Month CONTROL HTN Data Published for Rox Coupler Device
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.