Calif.–(BUSINESS WIRE)–ROX Medical, Inc., a
world leader in the development of unique minimally invasive medical devices
for the treatment of advanced COPD and resistant hypertension, today announced
the first clinical use of the ROX CO2UPLERTM at the Universitair Ziekenhuis
Brussel (University Hospital of Brussels) to treat resistant hypertension.
Resistant hypertension is defined as blood pressure that remains above an
optimal goal despite the concomitant use of antihypertensive medications from
three or more classes.
The ROX CO2UPLER is a small metallic stent-like implant that
creates a therapeutic fistula, a calibrated passage between the artery and
vein, which allows a calculated amount of blood to be rerouted from the artery
to the vein, returning back to the heart and lungs, thereby lowering peripheral
vascular resistance, and potentially blood pressure in hypertensive patients.
Professor Danny Shoors, MD, PhD, and Dr. Benjamin Scott of
the Interventional Department in the Cardiovascular Center, University Hospital
of Brussels performed the FLO2W Procedure and noted, “We are pleased to
have performed the first ever ROX FLO2W Procedure for this new approach to
hypertension, the acute impact on the patients’ blood pressure was greater than
we expected and we look forward to understanding how much these patients
benefit from the treatment over time.”
The ROX FLO2W Procedure, whereby the ROX CO2UPLER is placed,
has shown reduction in blood pressure in Chronic Obstructive Pulmonary Disease
(COPD) patients in ongoing clinical trials supported by the Company. ROX
Medical currently funds clinical studies to determine the benefits of the
treatment for patients with resistant hypertension, including some patients who
are not candidates for other device-based treatments, such as renal
“Based on early clinical results and observations we
are optimistic that the FLO2W Procedure may provide an entirely new and novel
tool for physicians treating patients with resistant hypertension,” stated
Rodney Brenneman, President and CEO of ROX Medical.
Hypertension, or High Blood Pressure (HBP), is the most
significant cardiovascular risk factor worldwide, and recent estimates suggest
that more than 75 million persons in the U.S. have HBP.(1) A recent clinical
study concluded that among U.S. adults with hypertension, 8.9% of these
patients met the criteria for resistant hypertension.(2) In the study adults
with resistant hypertension were also more likely to experience serious medical
conditions, including albuminuria and reduced renal function, and were found to
have medical histories with co-morbidities including heart disease, heart
failure, stroke, and diabetes mellitus.
The ROX ANASTOMOTIC COUPLER SYSTEM has received CE Marking
for treating both Advanced COPD and Hypertension.
About ROX Medical, Inc.
ROX Medical is located in San Clemente, California, and is currently conducting clinical studies
in the United States and Europe. ROX Medical is the only company that develops, manufactures
and sells medical devices intended to modify the cardiovascular system to help
offset the consequences of hypoxia and hypertension. The Company’s intellectual
property was initially developed in cooperation with Stanford
University, in Palo Alto, California.
The Company’s websites include www.roxmedical.com, and www.roxmedical.de.
About University Hospital of Brussels
Located in the heart of Europe, the Universitair Ziekenhuis Brussel (University
Hospital of Brussels) is one of Belgium’s
premier Centres of Excellence in healthcare, biomedical research and medical
education. The hospital is closely associated with the Vrije Universiteit
University). As a
top-rate hospital, the Universitair Ziekenhuis Brussel has gained recognition
at both a national and an international level.
1 Chobanian AV, Badris Gl, Blck HR, Cushman WC, Green LA,
Izzo JL Jr, et al. Heart. Lung and Blood Institute Joint National Committee on
Prevention, Detection, Evaluation and Treatment of High Blood Pressure,
National High Blood Pressure Education Program Coordinating Committee. The
Seventh Report of the Joint National Committee on Prevention, Detection,
Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA.
2 Persell SD. Prevalence of Resistand Hypertension in the
United States, 2003-2008. Hypertension. 2011;57: 1076-1080.