Northwell Health Conducting Clinical Trial on FDA Cleared Smartwatch-based Knee OA Device

Jun 30, 2019 | Knee Osteoarthritis, Medical Device, Osteoarthritis, SmartApp

Knee Osteoarthritis

Northwell Health, New York’s largest health system, will conduct a randomized, prospective clinical trial on 120 osteoarthritis patients with a FDA cleared smartwatch-based knee OA device.

Called e-vive™, the system is a digital wearable, app-based muscle activation and patient engagement system designed to delivery muscle stimulation therapy while also connecting patients with their healthcare providers in real time.

TrialSite News follows with a Question and Answer format for the reader to learn more.

Who is the manufacturer of the device?

CyMedica Orthopedics, Inc., a Scottsdale, AZ based medical technology company.  Founded in 2013 by Ronald Yagoda and Struan Coleman, the venture has raised $21.5 million in venture capital financing.

The venture develops and commercializes products that target joint injuries and the resulting muscle atrophy—the number one problem for patients recovering from joint surgery.  This Arizona-based venture is on a mission to address this problem with proprietary neuromuscular electrical stimulation. Their platform technology utilizes the first closed-loop power control systems to provide patients comfortable yet aggressive treatment.

Based on targeted searchers it would appear the venture has under 20 employees.

What is the e-vive Product?

Their e-vive product is designed to deliver wireless, app-controlled muscle stimulation therapy individualized for each patient’s comfort and convenience. CyMedica positions that the e-vive product helps keep patients engaged with their rehabilitation by tracking their progress and allowing data sharing with clinicians.  It includes A) a conductive garment with a built-in sensor technology, enabling the transmittal of critical range of motion data and steps, while also precisely holding the electrodes in place to ensure effective quadricep activation and B) Controller that uses their proprietary CyMotion technology to monitor and control the power delivered to the muscle for maximum comfort and effectiveness.  We provide a link to documentation.

Who are the Lead Investigators?

Lead investigators include Matthew Stweart Hepinstall, MD and Michael A. Mont, MD, vice president of Strategic Operations in Orthopedics at Northwell Health.

Study Description

The investigators will combine the muscle strengthening of e-vive with the activity and health data collected by wearable smartwatch devices to determine the effect of this technology on improving patient osteoarthritis (OA) symptoms.  Muscle weakness is a common clinical condition associated with knee osteoarthritis.

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