TAMPA, Fla., July 17, 2018 /PRNewswire-PRWeb/ -- Florida Hospital Pepin Heart Institute is the only hospital in Tampa Bay and one of only two hospitals in Florida, now enrolling patients who have unsuccessfully tried to control high blood pressure with medication to participate in a new clinical research study called CONTROL HyperTeNsion (HTN)-2. This innovative study is designed to evaluate the safety and effectiveness of a device called the ROX® Coupler, which is used to relieve pressure in a patient's arteries by diverting blood from the arteries into the veins.
The ROX® Coupler is a device, smaller than a pencil eraser, that is inserted into the artery and vein, using a thin catheter. The ROX® Coupler creates a passage between the iliac artery and iliac vein in pelvic area, redirecting a measured amount of blood from the artery to the vein. This minimally invasive procedure will be performed in one of Florida Hospital Tampa's five cardiac catheterization lab or hybrid operating rooms.
According to the American Heart Association, high blood pressure affects more than 100 million adults in the United States. Only about half successfully control their high blood pressure with medications and lifestyle changes.
"As blood pressure increases so do the risks associated with stroke, heart attack, heart failure and kidney failure," said Dr. Charles Lambert, Medical Director of Florida Hospital Pepin Heart Institute. "This approach to treatment has great potential to help patients who don't respond well to traditional blood pressure medication live longer, healthier lives."
To be eligible for the ROX® CONTROL HTN-2 clinical trial, patients should currently be taking three or more blood pressure medications every day and still have systolic pressure (the top number in a blood pressure reading) greater than 155 mmHg. In a previous trial in Europe, patients treated with the ROX Coupler experienced an average drop in blood pressure of 27 mmHg, which lasted up to 12 months.
"Clinical trials allow us to offer potentially lifesaving breakthroughs before they are available in many other hospitals," says Elizabeth Kohl, MS, MPH, CCRP, Director of the Dr. Kiran C. Patel Research Institute at Florida Hospital Pepin Heart Institute. "These leading-edge therapies provide advanced medical options for our patients while furthering scientific knowledge in the prevention, treatment, and management of cardiovascular disease. We are excited to partner with ROX Medical to bring this important advancement to our community."
For more information about the ROX CONTROL HTN-2 clinical trial, visit controlhtn2.com or https://clinicaltrials.gov/ct2/show/NCT02895386.
About Florida Hospital, West Florida Division of Adventist Health System
The West Florida Division of Adventist Health System is a 1,415 bed health care system currently comprised of nine acute-care hospitals including Florida Hospital Carrollwood, Florida Hospital Dade City, Florida Hospital Heartland Medical Center Lake Placid, Florida Hospital Heartland Medical Center Sebring, Florida Hospital North Pinellas, Florida Hospital Tampa, Florida Hospital Wauchula, Florida Hospital Wesley Chapel and Florida Hospital Zephyrhills, as well as two freestanding offsite Emergency Rooms including Florida Hospital Central Pasco ER and Florida Hospital Palm Harbor ER. Additionally, it has one post-acute care facility, Florida Hospital at Connerton Long Term Acute Care, over 45 multi-specialty Florida Hospital Physician Group practices, 15 Florida Hospital Express Care at Walgreens clinics and 6 Florida Hospital Centra Care Urgent Care Centers.
About Florida Hospital Pepin Heart Institute and Dr. Kiran C. Patel Research Institute
Florida Hospital Pepin Heart Institute, located at Florida Hospital Tampa, is a free-standing cardiovascular institute providing comprehensive cardiovascular care. Leading the way with the first accredited chest pain emergency room in Tampa Bay, the institute is among an elite few in the state of Florida chosen to perform the ground breaking Transcatheter Aortic Valve Replacement (TAVR) procedure and was the first in Tampa to offer the Watchman procedure to prevent blood clots in patients with atrial fibrillation. Florida Hospital Pepin Heart Institute and the Dr. Kiran C. Patel Research Institute, affiliated with the University of South Florida (USF), are exploring and conducting leading-edge research to develop breakthrough treatments long before they are available in most other hospitals. To learn more, visit http://www.FHPepinHeart.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 http://www.roxmedical.com.
SOURCE Florida Hospital Pepin Heart Institute
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