Vascular Dynamics, a Part of the Rainbow Medical Investment Cluster, Received FDA Approval to Begin Conclusive and Pivotal Trial Experimentation for Their Flagship Product Designed to Treat Chronic Hypertension

MOUNTAIN VIEW, California, August 22, 2017 /PRNewswire/ --

• The experiment will examine the effectiveness of the MobiusHD implant in the reduction of blood pressure among chronic patients for whom at least three different medications proved ineffective.
•  The objective of this innovative development is to reduce and control blood pressure by means of enhancing the signal of the sensory nervous system.
• A solution to one of the more common phenomena in the medical world that has yet to find a pharmaceutical or technological response and is predicted to suit the treatment requirements of millions of patients worldwide.

Vascular Dynamics, a medical device company currently developing an innovative treatment for hypertension and one of the leading principals of the Rainbow Medical Investment Cluster, announced that the Food and Drug Administration (FDA) approved the company's plans to initiate conclusive and pivotal trial experimentation to investigate the effectiveness of its flagship product, MobiusHD, in the treatment of chronic hypertension.

Vascular Dynamics was chosen by the FDA to participate in an accelerated EAP (Expedited Access Pathway) program, the objective of which is to catalyze innovative and life-saving experimental treatments, as a means of bringing them to clinical use among patients as soon as possible. In addition, the company is one of nine companies chosen for participation in an IDE (Investigational Device Exemptions) pilot program, to enable the execution of experiments on a smaller scale and an expedited pathway to FDA marketing approval.

The Solution to Reducing Drug Resistant Hypertension  

MobiusHD, a miniature invasive implant, changes the way by which patients who do not respond to medications for reducing hypertension are treated. The implant is inserted by means of a catheter and placed in the carotid, in a location containing baroreceptor nerves that regulate the heart's output, thereby regulating the body's blood pressure. Whenever these sensors are damaged, the brain receives erroneous commands that cause the increase in blood pressure. The implant developed by Vascular Dynamics enhances the sensors' signals and improves blood pressure regulation.