FDA Grants IDE Nod to Innovative High Blood Pressure Device

FDA Grants IDE Nod to Innovative High Blood Pressure Device

BOISE– 1/18/2012 – Zona Health, developer of non-invasive, non-drug treatments for hypertension, announced that the U.S. Food and Drug Administration (FDA) conditionally approved an Investigational Device Exemption (IDE) for a pivotal clinical trial to evaluate the Company’s patented isometric handgrip therapy technology (ZonaRx™) for use in the treatment of resistant hypertension (high blood pressure in the presence of two or more medications), an especially dangerous disease affecting hundreds of millions of people worldwide. FDA approval of the IDE makes Zona Health’s study the first pivotal trial of isometric handgrip therapy for hypertension treatment.

The investigatory team for the study includes JoAnn Lindenfeld, M.D., Director of the Cardiac Transplant Program at University Hospital in Aurora, Colorado, and a member of the FDA Devices Committee; Suzanne Oparil, M.D., Professor of Medicine and Director of the Vascular Biology and Hypertension Program in the Division of Cardiovascular Disease at the University of Alabama at Birmingham, and Co-chair of The Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8); and Kenneth Kronhaus, M.D., Ph.D., Cardiologist, and American Heart Association Spokesman.

“We are very pleased with the IDE approval and look forward to commencing the pivotal study to provide longer term safety and efficacy data of our ZonaRx™ hypertension treatment technology in this set of resistant hypertensive patients,” said Steven Wood, President and CEO of Zona Health. “We believe this innovative treatment has the potential to provide patients with an effective way to control their blood pressure when other treatment options are insufficient.”

The pivotal trial is a double-blind, randomized, controlled study designed to evaluate the safety and effectiveness of isometric handgrip therapy with the ZonaRx™ in patients who are taking two or more medications but cannot reach their blood pressure goals. The study will enroll approximately 200 patients in several medical centers across the U.S.

The ZonaRx™ is a medical device which enables patients to easily perform isometric handgrip therapy in the comfort of their homes. The device uses patented technology to accurately customize the therapy for each individual patient in order to trigger a specific physiological response that leads to lower blood pressure. The ZonaRx does not require a permanent implant or invasive surgery.

Clinical research shows that Zona Health’s isometric handgrip therapy may provide a significant reduction in blood pressure levels for the majority of hypertensive patients. Across several earlier studies, 135 out of 136 participants achieved significant blood pressure drops in eight weeks or less.

Hypertension is the leading attributable cause of death worldwide. It is a significant, escalating global healthcare problem affecting approximately 1.2 billion people and is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death. High blood pressure is estimated to have a direct cost to the global healthcare system of more than $500 billion annually. Although pharmaceutical therapy plays a primary role in hypertension management, drugs alone are sometimes not effective for all patients. As a result, despite lifestyle changes and the availability of modern antihypertensive agents, approximately 50 percent of patients with hypertension remain uncontrolled, and approximately 15-20 percent of those are resistant.

About Zona Health

Zona Health is a privately held medical device company headquartered in Boise, Idaho. The Company’s proprietary technology is designed for effective, non-drug and non-invasive treatment of hypertension. Zona Health currently manufactures and markets the Zona Plus™, a medical device for the improvement of overall cardiovascular health. Additional information can be found at www.zona.com.

The FDA has conditionally approved an investigational device exemption (IDE) for a pivotal clinical trial to evaluate a new patented isometric handgrip therapy technology. A product of Zona Health (Boise, ID), the ZonaRx device was developed for use in the treatment of resistant hypertension (high blood pressure that persists despite treatment by two or more medications). The IDE approval marks the first pivotal trial of isometric handgrip therapy for hypertension treatment.

Earlier clinical studies demonstrate that the isometric handgrip therapy could provide “a significant reduction in blood pressure levels for the majority of hypertensive patients,” according to Zona Health. According to earlier data, 135 out of 136 study participants achieved significant blood pressure drops in eight weeks or less.

From the announcement:

The pivotal trial is a double-blind, randomized, controlled study designed to evaluate the safety and effectiveness of isometric handgrip therapy with the ZonaRx™ in patients who are taking two or more medications but cannot reach their blood pressure goals. The study will enroll approximately 200 patients in several medical centers across the U.S.

The ZonaRx™ is a medical device which enables patients to easily perform isometric handgrip therapy in the comfort of their homes. The device uses patented technology to accurately customize the therapy for each individual patient in order to trigger a specific physiological response that leads to lower blood pressure. The ZonaRx does not require a permanent implant or invasive surgery.

Source : http://www.qmed.com/news/fda-grants-zona-health-ide-approval-innovative-study-high-blood-pressure

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