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FDA green-lights trial of carotid implant for resistant hypertension
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Vascular Dynamics announced that the FDA approved its investigational device exemption application to begin a pivotal trial of a device implanted in the carotid artery to treat patients with resistant hypertension.
The system (MobiusHD) amplifies signals received by baroreceptors in the carotid artery, which increases the body’s ability to lower BP via vasodilation, according to a press release issued by the company.
The trial, CALM 2, will evaluate the device in patients from the United States and Europe with uncontrolled hypertension despite use of at least three antihypertensive medications, according to the release.
In CALM, the first-in-human study of the device, 25 patients had a mean change in office cuff BP of –23/–10 mm Hg and a mean change in 24-hour ambulatory BP of –14/–8 mm Hg at 180 days, according to results presented at VIVA 15. At the time, nine patients had had 1-year follow-up, and for them, office cuff BP was reduced by a mean of –26/–16 mm Hg.
“The rigor and focus of the CALM 2 trial has been crafted and improved from much of what we learned from prior studies,” Bryan Williams, MD, FRCP, FESC, FAHA, co-principal investigator of the trial and chair of medicine at University College London, said in the release. “CALM 2 will offer patients a therapeutic alternative and a level of medical monitoring to which they would never have access outside of a clinical trial.”
There has been much activity in development of device therapy for resistant hypertension in recent years, most notably in renal artery denervation systems. More than a dozen companies had renal denervation programs until SYMPLICITY HTN-3, the first phase 3 trial of a renal denervation technology (Symplicity, Medtronic), failed to show efficacy.
As a result, some companies stopped developing the technology and others rethought their approaches.
Device therapies remain a need for certain patients with hypertension, Gregg W. Stone, MD, co-principal investigator of CALM 2, director of cardiovascular research and education for Columbia University Medical Center/NewYork-Presbyterian Hospital, co-director of medical research and education at the Cardiovascular Research Foundation and a member of the Cardiology Today’s Intervention Editorial Board, said in the release.
“In clinical practice, we are regularly faced with those hypertension patients who simply do not respond to medication or lifestyle changes,” he said. “Initiating this trial is an important step toward identifying additional viable treatments to help this large population of patients.” – by Erik Swain
Disclosures: Stone reports co-chairing a study sponsored by Vascular Dynamics and having financial ties with AstraZeneca, Atrium, Boston Scientific, Daiichi Sankyo/Eli Lilly and InspireMD. Williams reports co-chairing a study sponsored by Vascular Dynamics.