Rox Medical has completed enrollment in a Phase III trial of its Rox Coupler blood pressure reduction device. Final results from the study are expected by fall.
The multicenter, prospective, randomized, controlled and double-endpoint blinded trial will evaluate ambulatory and office blood pressure at six months in patients ages 18 to 80 with treatment resistant hypertension.
The device is inserted via a catheter in the upper leg, creating a fixed volume arterial-venous anastomosis that reduces blood pressure and vascular resistance. The procedure is minimally invasive, requires no sedation and can be reversed by placing a stent over the arterial side of the anastomosis.
Rox CEO Rodney Brenneman told Device Daily Bulletin that device-mediation can benefit patients whose blood pressure isn’t controlled with drugs, or who have problems with adherence or side effects.
The Rox Coupler may also help patients who don’t respond to treatment via renal denervation systems, he said. “The Rox approach works immediately in the cath lab and they walk out of the hospital the next day.” That may be more appropriate for patients with dangerously high blood pressure, Brenneman added.
The Rox is CE-marked for hypertension and chronic obstructive pulmonary disease. The company hopes to file for an investigational device exemption with the FDA later this year. — Lena Freund
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