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.
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.
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.
Efi Cohen-Arazi, CEO of Rainbow Medical, said, "We are pleased to have received such a meaningful expression of faith from the FDA for the Vascular Dynamics solution. Experimenting within the EAP framework emphasizes the medical need and recognition of the innovative solution we have developed. This pathway can significantly shorten the product's time to market and bring relief to millions of patients worldwide coping with chronic hypertension and drug resistance."
The pivotal study, CALM 2 (Controlling and Lowering Blood Pressure with MobiusHD), taking place in the United States and for the first time in Europe, is intended to examine the effectiveness of MobiusHD in controlling, regulating and lowering high blood pressure in chronically ill patients who, although they have received multiple hypertension medications, saw no improvement in their condition. It is one of the most common phenomena in medicine yet to find a sufficient pharmaceutical or technological response.
"The experiment is an extremely important milestone, in which we will be able to confirm the latent potential in our technology for the treatment of this enormous global population, and prove that MobiusHD is capable of changing and saving lives," added Robert Stern, President and CEO of Vascular Dynamics.
Source: Vascular Dynamics and Rainbow Medical
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