FDA Grants Expedited Access Pathway Designation for Vascular Dynamics' MobiusHD to Treat Resistant Hypertension

February 1, 2017—Vascular Dynamics, Inc. announced that the US Food and Drug Administration (FDA) has approved the company’s application to participate in the Expedited Access Pathway (EAP) program for its MobiusHD device for the treatment of resistant hypertension. The MobiusHD system recently received European CE Mark approval, but it is not commercially available in the United States.

According to the company, the MobiusHD system capitalizes on the ability of the body’s baroreceptor mechanism to regulate blood pressure. The MobiusHD implant is designed to amplify the signals received by the surrounding arterial baroreceptors and thereby amplify the body’s natural response to lower blood pressure through vasodilation.

Professor Brian Williams, MD, who serves as Coprincipal Investigator of the worldwide CALM II clinical trial, commented in the company's press release, “Among the benefits of the technology are that it may reduce ambulatory blood pressure in resistant hypertension patients who have not benefited from other device- or drug-based treatments. The MobiusHD technology may provide an important solution for those patients. We are enthusiastic about the product’s potential as we have seen tremendous results in early studies in the United States and Europe.”

Gregg Stone, MD, who is also Coprincipal Investigator of the CALM II clinical trial, added, “In clinical practice, we regularly observe that despite multiple treatment modalities, many patients are still not responding adequately to therapy, whether it be lifestyle changes, multiple drug therapy, or the combination of each. This lack of response significantly increases their risk of further complications.”

Vascular Dynamics advised that the EAP program is a focused initiative recently launched by FDA to significantly accelerate access to innovative medical treatments for patients and their physicians in the United States. The program was designed for certain medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions, such as resistant hypertension, that may be subject to premarket approval applications.

George Bakris, MD, Chairman of the CALM II clinical trial hypertension committee stated, “The EAP designation for the MobiusHD device comes at a critical time for hypertension physicians, who are actively looking for treatment options for patients who are not adequately managed with current guideline-directed therapies."