MANHASSET, NY – Teams from Northwell Health’s Sandra Atlas Bass Heart Hospital at North Shore University Hospital and Feinstein Institute for Medical Research are the first in New York State – and among the first nationally – to treat a patient with a new implantable device for uncontrolled blood pressure as part of a recently-launched clinical study.
The ongoing trial, called CONTROL HyperTeNsion (HTN)-2, evaluates the safety and efficacy of the ROX Coupler to create an arteriovenous anastomosis, or direct connection between small arteries and veins in the iliac vessels, in patients with high blood pressure. Uncontrolled blood pressure is a serious condition which can lead to heart attack, stroke or death if not adequately treated. For some patients, medication and lifestyle changes do not sufficiently lower blood pressure to safe levels.
“We are thrilled to offer patients the opportunity to participate in this new trial because the device we are studying has been shown to decrease blood pressure significantly more than other devices that have been studied in hypertension,” said Andrew Galmer, DO, investigator on the study and vascular medicine specialist in Northwell’s Department of Cardiology. “In my opinion, the ROX Coupler is the most intriguing new device being studied in the field of hypertension.”
Dr. Galmer and his colleagues are part of a large, multi-center trial that will include up to 30 study sites in the United States. The ROX Coupler and FLOW procedure being tested in the trial creates a passage between an artery and a vein in the pelvis, which redirects a measured amount of arterial blood to the veins. This therapy is intended to reduce peripheral vascular resistance and add a compliant venous element to the arterial system through creation of a therapeutic arteriovenous anastomosis with the ROX Coupler. Early study results show the ROX device is capable of decreasing blood pressure close to 30 mmHg, compared to other devices being studied in hypertension that decrease the systolic blood pressure by 5-10 mmHg. The ROX Medical Coupler is an investigational device and is limited by federal law to investigational use only.
If you are between the ages of 22 to 85 with uncontrolled blood pressure and would like to learn more about the trial, please contact Theresa Yirerong at 516-562-2653 or TYirerong@northwell.edu.
About the Feinstein Institute
The Feinstein Institute for Medical Research is the research arm of Northwell Health, the largest healthcare provider in New York. Home to 50 research laboratories and to clinical research throughout dozens of hospitals and outpatient facilities, the Feinstein Institute includes 4,000 researchers and staff who are making breakthroughs in molecular medicine, genetics, oncology, brain research, mental health, autoimmunity, and bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we empower imagination and pioneer discovery, visit FeinsteinInstitute.org.
About ROX Medical, Inc.
ROX Medical is a privately held medical device company pioneering an innovative interventional vascular therapy for Uncontrolled Hypertension. ROX Medical has developed a simple, minimally invasive and reversible procedure that may be performed in under one hour without sedation in a standard vascular catheterization lab. More than 67 million Americans are living with high blood pressure, and 16 million know they have high blood pressure and are receiving medication for it but still don’t have their pressure under control. ROX Medical is conducting additional studies in hypertension and is available commercially in Europe under CE mark. For more information, visit www.roxmedical.com.
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Heather E. Ball Mayer