The MobiusHD minimally invasive system from Vascular Dynamics has been granted CE mark approval for the treatment of resistant hypertension.
“Receiving CE mark approval for the treatment of resistant hypertension is a major milestone for our company as we validate our novel solution for the millions of people whose hypertension is not adequately controlled by drugs,” says Robert Stern, president and CEO of Vascular Dynamics. “Initial results suggest significant improvement in the average blood pressure readings post barostenting procedure in our ongoing CALM first-in-human clinical trials in the US and EU and we are progressing toward the filing of our International Pivotal study to support our US FDA approval.”
According to a press release, the MobiusHD system is designed to exploit the ability of the body’s baroreceptor mechanism to regulate blood pressure. The MobiusHD implant intended to amplify the response of vasodilation by amplifying the signals received by the surrounding arterial baroreceptors.
“Options for patients to reduce their blood pressure are limited once they have failed multi-drug therapy. We have seen very good results in the patients we have treated at our centre in the first-in-human clinical trial with the MobiusHD barostenting procedure. We look forward to being able to provide it to our patients who have limited treatment options,” says Wilko Spiering, UMC Utrecht, president of the Dutch Society of Vascular Internists and Secretary of the Dutch Society of Hypertension. “Our team looks forward to working with the Vascular Dynamics team to accelerate the clinical process with the next round of studies in the EU.”
Gregg W Stone, director of Cardiovascular Research and Education at Columbia University Medical Center/New York Presbyterian Hospital and co-chair of the upcoming Vascular Dynamics’ MobiusHD International pivotal study, says “Most drugs have side effects leading to poor compliance, and more invasive approaches have other drawbacks.”
“The MobiusHD is a simple, passive implant that is designed to reduce blood pressure while preserving the body’s natural ability to modulate blood pressure. The minimally invasive MobiusHD barostenting procedure could be life changing for this patient population while also reducing the cost of healthcare,” adds Stone.
“We now have eight active centres in the US and 13 centres in the EU open for recruitment. We are taking a measured approach with our clinical trials to ensure that we are gathering the appropriate data and maintaining our safety profile,” adds Stern.