April 1, 2013 — Rox Medical announced enrollment of the first U.K. patients in the CONTROL-HTN international randomized controlled trial of the Rox Flow procedure for the treatment of resistant hypertension. The first patients were enrolled at Eastbourne General Hospital, East Sussex, U.K. by doctors Neil Sulke and Stephan Furniss. For the two patients randomized to treatment, the Rox procedure was performed in the cardiac cath lab in under one hour.
"It was a very enjoyable and straightforward procedure on a patient with very difficult to control blood pressure," said Furniss. "The procedure was relatively painless and the patient showed significant improvement in blood pressure right after the procedure that we'll be anxious to monitor over the coming weeks and months. "This could be a very important new device treatment option for resistant hypertension patients," said Furniss. "We are anxious to enroll additional patients into this exciting trial."
"We like the fact that the Rox procedure is reversible and that it can treat patients who are not candidates or don't seem to respond to renal denervation," added Sulke.
Rox Medical's Flow procedure is a minimally invasive, catheter procedure to place a small coupler between the artery and vein in the upper leg. The procedure reduces peripheral vascular resistance and by diverting some arterial blood to the veins, adds lost compliance back into the vascular system. Uniquely, the Flow procedure only involves vascular structures away from vital organs like the kidneys, has an immediate effect and is fully reversible. The procedure also does not require heavy pain medications common to renal ablation techniques. The Rox procedure holds the promise of a meaningful long-term reduction in hypertension that may be combined with other device hypertension therapies.
The Rox Flow procedure for hypertension is not approved for use in the United States.
For more information: www.roxmedical.com