US-based medical device company CyMedica Orthopedics has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its e-vive, an app-driven solution for pre and post-operative knee surgery rehabilitation.
The e-vive wireless muscle stimulation device has been designed as an app-based data-driven muscle activation therapy and patient engagement solution. It is used to treat complications associated with muscle atrophy due to which patients lose 60% of their quad strength after knee surgery.
The new device features an intuitive interface to simplify the virtual operation compatible on any smart phone.
It consists of a conductive garment, with built-in sensor technology which relays critical range of motion data and steps while precisely holding the electrodes in place to ensure effective quadricep activation.
The data are stored in a secure cloud based portal which can be accessed by the healthcare providers to track patient progress and patient reported measures in order to provide more predictable outcomes in a cost-effective way.
Its controller is based on the company’s CyMotion Technology to monitor and control the power delivered to the muscle to ensure comfort and effectiveness.
CyMedica co-founder and Sports Medicine Surgeon at Hospital for Special Surgery Struan Coleman said: My patients now have access to a world-class muscle activation device that not only improves their quadriceps function, but also allows me to remotely monitor the progress of their rehabilitation.
“The e-vive technology captures key data points, such as range of motion, activity levels, pain scores and more.
"Through e-vive I am able to deliver better outcomes both for my patients and for the hospitals supporting the new economics of quality based care"
Image: The e-vive System. Photo: courtesy of CyMedica Orthopedics, Inc.