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# FDA OKs MobiusHD CALM 2 Trial
- URL: https://www.fdaweb.com/fda-oks-mobiushd-calm-2-trial/
- Published: 2017-08-15T12:00:00.000Z
- Updated: 2026-09-14T22:41:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139388

FDA has approved a Vascular Dynamics IDE application to start a pivotal CALM 2 (Controlling and Lowering Blood Pressure with MobiusHD) trial of its Mobius system for treating resistant hypertension. The trial will evaluate patients from multiple U.S. sites whose hypertension remains uncontrolled despite three or more antihypertensive pharmacologic therapies.

The minimally invasive MobiusHD system is said to capitalize on the ability of the body’s baroreceptor mechanism to regulate blood pressure. The company says that baroreceptors located in the carotid artery sense blood pressure and relay that information to the brain. The MobiusHD implant is designed to amplify the signals received by the surrounding arterial baroreceptors, and thus increase the body’s natural response to lower blood pressure through vasodilation.

The company has been selected to participate in FDA’s Expedited Access Pathway that can significantly accelerate access for U.S. patients and their doctors to innovative medical treatments.