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Home/Large Joints and Extremities/Muscle Stimulation Device Receives FDA Clearance
Large Joints and Extremities

Muscle Stimulation Device Receives FDA Clearance

January 30, 2017 1 min read Premium comments

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Muscle Stimulation Device Receives FDA Clearance
Courtesy of CyMedica Orthopedics, Inc.
Secondary

CyMedica Orthopedics, Inc., in Scottsdale, Arizona, recently announced that it received FDA 510(k) clearance for e-vive, an app-controlled muscle stimulation device designed to reduce muscle atrophy and keep patients better engaged in their home rehabilitation before and after anterior cruciate ligament and total knee replacement surgery.

According to the press release, the e-vive app, which will work on any smartphone, allows important data to be collected through embedded garment sensor technology and then stored on a secure cloud-based portal. Both patients and their providers will easily be able to track how rehabilitation is progressing.

“The launch of e-vive represents a breakthrough in the treatment of muscle atrophy of the knee,” said Struan H. Coleman, M.D., Ph.D., sports medicine surgeon at the Hospital for Special Surgery in New York City and CyMedica co-founder in the release. “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.”

Rob Morocco, president and CEO of CyMedica Orthopedics said in the release, “CyMedica is committed to supporting value-based care by improving the standard of care for [anterior cruciate ligament and total knee replacement surgery] 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.”

React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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