Data Published in The Lancet Shows Positive Results at Primary Endpoint in the Treatment of Resistant Hypertension with MobiusHD Device
(Thomson Reuters ONE) -
Publication Follows Positive Interim Results in US and EU Patients Presented at
the European Society of Cardiology Conference
MOUNTAIN VIEW, Calif., Sept. 01, 2017 (GLOBE NEWSWIRE) -- Vascular Dynamics,
Inc. (VDI), a privately held medical device company developing novel solutions
for the treatment of hypertension, today announced European results of the
company's first-in-human trial of its MobiusHD(®) implant published in The
Lancet. The publication reported an average reduction of 24-hour ambulatory
systolic blood pressure of 21 mmHg from baseline in the 30 European patients 6
months after implantation. Moreover, the Study authors reported that
implantation of the MobiusHD device was straightforward for experienced
interventionists, with a 100 percent procedural success rate.
The Lancet publication, which was posted today online, noted that the CALM-
FIM_EUR study was a first-in-human feasibility study in which 30 patients were
enrolled at 6 European centers in the Netherlands (5) and Germany (1) between
December 2013 and February 2016. All patients had resistant hypertension,
defined as office systolic blood pressure above 160 mmHg, despite the use of
three or more antihypertensives, including a diuretic. The MobiusHD devices were
implanted unilaterally in the internal carotid artery. Mean office blood
pressure was 184/109 mmHg at baseline and was reduced by 24/12 mm Hg at 6
months. Mean baseline 24-hr ambulatory blood pressure was 166/100 mmHg at
baseline and was reduced by 21/12 mmHg at 6 months despite an observed reduction
in hypertensive medication. The investigators reported 6 serious adverse events,
all of which were reported to have resolved without sequelae.
"These published results of the CALM-FIM_EUR study demonstrate that the MobiusHD
device may significantly reduce both office and ambulatory blood pressure among
patients on three or more drugs who have been unable to control their
hypertension," said Wilko Spiering, MD, internist-vascular medicine specialist,
University Medical Center Utrecht, the Netherlands and President of the Dutch
Hypertension Society, lead author of the study. "Our positive experience with
the MobiusHD device demonstrates the need for continued investigation in a sham-
controlled setting, which is currently running in the Netherlands and is
starting up in the United States, United Kingdom, and Germany shortly."
The Lancet publication comes immediately following the presentation of interim
results of the CALM-FIM trials (US and EU study data) at a podium session at the
2017 Annual Congress of the European Society of Cardiology in Barcelona by Dr.
Spiering.
"These results present a potentially significant advance in the treatment of
hypertension, particularly with regard to those patients whose blood pressure
has remained uncontrolled despite lifestyle changes and multi-drug therapy,"
said Dr. Bryan Williams, co-Principal Investigator of the CALM 2 trial from
University College London (UCL) Institute of Cardiovascular Science and National
Institute for Health Research UCL Hospitals Biomedical Research Centre. He is
also Chairman of the European Council on Hypertension of the European Society of
Cardiology. "We hope that continued study in the upcoming CALM 2 trial will
continue to garner the results we've seen thus far, which will provide an
important addition to our approach to controlling this incredibly pernicious and
deadly disease."
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.
"The benefit of a minimally invasive therapy that can reduce ambulatory blood
pressure significantly in these truly resistant patients, including those that
have failed renal denervation, has always been our goal," said Robert Stern,
president and CEO of Vascular Dynamics Inc. "With these positive results, we
will now press on to gather the sham randomized controlled data to ensure that
the MobiusHD can impact patient care positively."
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 ten 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
Unternehmensinformation / Kurzprofil:
Datum: 02.09.2017 - 00:30 Uhr
Sprache: Deutsch
News-ID 558578
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contact information:
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Kategorie:
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