Vascular Dynamics, Inc. (VDI) announced today the first patient has been treated with the MobiusHD device; 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one of the first FDA approvals of an Investigational Device Exemption application (IDE) following the FDA’s issuance of draft guidance on IDEs for early feasibility studies.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.”