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ROX Medical Announces First Clinical Use of the ROX FLO2W Procedure for the Treatment of High Blood Pressure in Resistant Hypertension Patients

Tue, 11/01/2011 - 8:42pm

 

SAN CLEMENTE, 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 denervation.

"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 Brussel (Brussels 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. 2003;289(19):2560-72.

2 Persell SD. Prevalence of Resistand Hypertension in the United States, 2003-2008. Hypertension. 2011;57: 1076-1080.

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