Vascular Dynamics Announces FDA Approval to Initiate CALM 2 Trial for MobiusHD® System for the Treatment of Resistant Hypertension
(Thomson Reuters ONE) -
MOUNTAIN VIEW, Calif., Aug. 15, 2017 (GLOBE NEWSWIRE) -- Vascular Dynamics,
Inc., (VDI) a privately held medical device company developing novel solutions
for the treatment of hypertension, today announces that the United States Food
and Drug Administration (FDA) has approved the company's Investigational Device
Exemption (IDE) application to initiate its pivotal trial for its
MobiusHD® System for the treatment of resistant hypertension.
The CALM (Controlling and Lowering Blood Pressure with MobiusHD) 2 trial is a
multi-center, prospective, randomized, double-blind, sham-controlled pivotal
study designed to evaluate the safety and effectiveness of the MobiusHD System.
The company will evaluate patients from select locations throughout the United
States whose hypertension remains uncontrolled despite using three or more anti-
hypertensive pharmacologic therapies. VDI also intends to conduct the CALM 2
trial in certain European countries following appropriate regulatory
authorization.
"The rigor and scientific focus of the Calm 2 trial has been crafted and
improved from much of what we learned from prior studies. Calm 2 will offer
patients a therapeutic alternative and a level of medical monitoring to which
they otherwise would never have access outside of a clinical trial," said Bryan
Williams co-Principal Investigator of the Calm 2 trial and Chair of Medicine at
University College London and Director of the NIHR UCLH/UCL Biomedical Research
Centre and Director of Research at UCL Hospitals. He is Chairman-Elect of the
European Council on Hypertension of the European Society of Cardiology.
"In clinical practice, we are regularly faced with those hypertension patients
who simply do not respond to medication or lifestyle changes. Initiating this
trial is an important step toward identifying additional viable treatments to
help this large population of patients," said Gregg Stone, MD, Co-Principal
Investigator of the CALM 2 trial and director of cardiovascular research and
education for Columbia University Medical Center/New York-Presbyterian Hospital
and co-director of medical research and education at the Cardiovascular Research
Foundation.
The company has been chosen as a participant in the FDA's Expedited Access
Pathway (EAP) program, a focused initiative to significantly accelerate access
for US patients and their physicians to innovative medical treatments. VDI is
also one of only nine companies chosen for the FDA's Early Feasibility Study
Investigational Device Exemptions (IDE) Pilot Program, which enables companies
to conduct smaller-scale studies under the guidance of the Agency in the United
States in order to meet the requirements for an earlier pathway toward approval.
"Initiating the CALM 2 trial is an important milestone for Vascular Dynamics as
it allows us the opportunity to demonstrate the potential utility of our
technology in a significant patient population," said Robert Stern, president
and CEO of Vascular Dynamics. "With our participation in both the EAP and IDE
programs, we also have the unique opportunity to work closely with the FDA to
ensure a more rapid start to the trial while still maintaining the high
standards of safety, efficacy and scientific validity required by the program."
The MobiusHD System, a minimally-invasive system, capitalizes on the ability of
the body's baroreceptor mechanism to regulate blood pressure. Baroreceptors are
receptors located in the carotid artery that sense blood pressure and relay that
information to the brain. The MobiusHD implant is designed to amplify the
signals received by the surrounding arterial baroreceptors, and thereby increase
the body's natural response to lower blood pressure through vasodilation.
About Resistant Hypertension
Hypertension, or elevated blood pressure, is a common medical condition that
currently affects one billion people worldwide.1 If left untreated, hypertension
can cause life-threatening problems, including heart attack, aneurysm, stroke or
kidney failure. Patients with hypertension can often reduce their risk factors
by making lifestyle changes such as losing weight, quitting smoking, and
increased exercise. In cases with advanced hypertension, medical therapies may
be prescribed. Resistant hypertension cannot be controlled with medical
therapies. Patients experiencing resistant hypertension are at four times
greater risk of cardiovascular events compared with hypertensive patients
achieving blood pressure targets.2 The American Heart Association (AHA)
estimates that high blood pressure costs the U.S. $46 billion each year,
including the cost of healthcare services, medications to treat high blood
pressure, and lost productivity.
About Vascular Dynamics, Inc.
Vascular Dynamics develops catheter-delivered technologies to bring a better
quality of life to patients who are resistant to conventional treatments for
hypertension. The device is covered by seven issued and pending U.S. and
international patents. The MobiusHD system has received a CE Mark for the
treatment of hypertension in the European Union. However, the MobiusHD system
is not commercially available in the United States. More information is
available at www.vasculardynamics.com.
CAUTION: In the United States, the MobiusHD Device is limited by law to
investigational use only.
1 Kearney PM, et al. Global burden of hypertension: Analysis of worldwide data.
Lancet. 2005;365(9455):217-23
2 Pierdomenico SD, Lapenna D, Bucci A, et al. Cardiovascular outcome in treated
hypertensive patients with responder, masked, false resistant, and true
resistant hypertension. Am J Hypertens. 2005;18: 1422-8.
Contact:
Jules Abraham
917-885-7378
jabraham(at)vasculardynamics.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Vascular Dynamics, Inc. via GlobeNewswire
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Datum: 15.08.2017 - 14:30 Uhr
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