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.