FDA Clears App-Driven Muscle Activation Therapy for Pre and Post-Op Knee Surgery Rehab

CyMedica Orthopedics, developer and manufacturer of muscle rehabilitation systems announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for e-vive—the first of its kind app-controlled, data-driven muscle activation therapy and patient engagement solution designed to empower at-home pre-hab to rehab muscle strengthening for ACL and total knee replacement patients.
 
The innovative e-vive wireless muscle stimulation device was designed to address the problems associated with muscle atrophy where patients can lose over 60% of their quad strength after knee surgery¹. Post surgical muscle atrophy can cost up to $4,200 per episode due to additional rehabilitation, and a higher likelihood of readmissions².
 
The new e-vive app features an intuitive interface for simplified operation on virtually any smart phone with embedded garment sensor technology that transmits key data points directly to a secure cloud based portal, where providers can track patient progress and patient reported measures to deliver more predictable outcomes, at a better cost.
 
“The launch of e-vive represents a breakthrough in the treatment of muscle atrophy of the knee. 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”—Struan Coleman, MD, PhD Sports Medicine Surgeon at Hospital for Special Surgery and CyMedica co-founder.
 
“CyMedica is committed to supporting value-based care by improving the standard of care for ACL and TKA rehabilitation patients. With the launch of e-vive, CyMedica is ideally positioned to partner with healthcare providers looking to improve outcomes, reduce costs and enhance patient satisfaction”—Rob Morocco, president and CEO.
 
References
¹Stevens, Snyder-Mackler, et al, University of Delaware J of Bone and Joint Surgery, Strength of the quad femoris muscle and functional recovery after reconstruction of the ACL, 1995.
²Chen, et.al. (2013). Journal of Pain research. 2013:6 595–603.