SOURCE: Vascular Dynamics, Inc.

Vascular Dynamics, Inc.

September 23, 2013 08:30 ET

Vascular Dynamics, Inc. Initiates "First in Human" Clinical Study of Its MobiusHD™ Device for the Treatment of Drug Resistant Hypertension

MOUNTAIN VIEW, CA--(Marketwired - Sep 23, 2013) - Vascular Dynamics, Inc. (VDI) announced today the first patient has been treated with the MobiusHDdevice; a catheter-delivered implant designed for the treatment of drug resistant hypertension. Dr. Chandan Devireddy of Emory University School of Medicine treated the first patient in the FDA-approved CALM-FIM_US Study. The study is a prospective, open-label, controlled, multi-center clinical trial to be conducted at five centers in the United States. The CALM-FIM_US Study represents one of the first FDA approvals of an Investigational Device Exemption application (IDE) following the FDA's issuance of draft guidance on IDEs for early feasibility studies. The intent of FDA's guidance is to foster early-stage development of medical devices within the United States to address clinical needs and improve patient care, particularly when alternative treatments or assessments are unavailable.

Dr. Devireddy stated, "Hypertension continues to grow as a global epidemic. Despite advances in medical therapy, a growing number of patients suffer from drug resistance and this population has very few options available to modulate blood pressure once they have failed multi-drug therapy. The MobiusHD device might offer a life-changing treatment option for patients with resistant hypertension."

"The MobiusHD investigational device represents a potential breakthrough in the treatment of resistant hypertension," said Robert A. Stern, President and Chief Executive Officer of Vascular Dynamics, Inc. "Our team has been working closely with the FDA for the last year within the early feasibility program, and we are grateful for the Agency's willingness to foster the development of this innovative therapeutic option."

About Vascular Dynamics, Inc. headquartered in Mountain View, California, the company seeks to provide safe, minimally invasive solutions for the treatment of refractive or resistant hypertension. Resistant hypertension is high blood pressure that does not respond to standard medical treatments. The company has developed a nitinol implant delivered by catheter to the carotid sinus that is designed to increase the signals generated by the surrounding arterial baroreceptors. Baroreceptors are a type of mechanoreceptor that detect the pressure of blood flowing through them, and send messages to the central nervous system to increase or decrease total peripheral resistance and cardiac output. Vascular Dynamics was one of the nine companies chosen in 2012 by the FDA to participate in the Early Feasibility Study IDE Pilot Program. The company is conducting clinical trials in the US and Europe to evaluate the safety and performance of the MobiusHD device. The studies are open-label, controlled, multi-center, first-in-human clinical trials.

CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.
MobiusHD is a trademark of Vascular Dynamics, Inc. in the United States and other countries.

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