Johns Hopkins’ HEPIUS Innovation Laboratory Receives FDA Breakthrough Device Designation for Implantable Ultrasound Sensor for Patients With Spinal Cord Injury
Baltimore, MD – The HEPIUS Innovation Laboratory at Johns Hopkins University announced today that the FDA granted Breakthrough Device Designation for the Multi-function Spinal Cord Implant (MUSIC) device, which provides critical temporary ultrasound imaging during the acute recovery phase after spinal cord injury (SCI). Some 17,000 new cases of SCI are diagnosed annually in the US but current technologies are lacking in their ability to directly monitor the injury site.
MUSIC is an epidural, flexible, wired patch placed over the site of injury after surgical decompression of the spinal cord. The device will perform ultrasonic imaging of spinal cord structures and Doppler blood flow imaging to help clinicians directly quantify blood flow and identify perfusion ranges for optimal patient recovery. Furthermore, the ultrasound images generated by MUSIC can monitor the spinal cord for swelling and development of hematoma.
The HEPIUS research program that developed MUSIC is sponsored by DARPA’s Bridging the Gap Plus (BG+) program. Dr. Amir Manbachi (Assistant Professor of Neurosurgery and Biomedical Engineering, Johns Hopkins Medicine) and Dr. Nicholas Theodore (Professor of Neurosurgery Johns Hopkins Medicine), co-inventors of the MUSIC technology and co-founders of the HEPIUS Innovation Laboratory, are internationally recognized pioneers in the fields of ultrasound and spinal cord injury. The device is the fruit of their vision and partnership with world-class ultrasound manufacturing industry, Sonic Concepts, Inc. (Bothell, WA)
“The MUSIC device could revolutionize our ability to directly monitor the injury site in SCI patients,” said Dr. Theodore. “This technology has the potential to dramatically improve patient outcomes.”
“This is an ambitious, futuristic invention that offers high-resolution images of the spinal cord immediately after surgery,” said Dr. Manbachi. “MUSIC exemplifies the abundant promise of implantable and wearable ultrasound devices in medicine.”
The breakthrough designation approval comes as a result of a fairly large team of outstanding experts at Johns Hopkins HEPIUS Innovation laboratory, working side by side, managed by Chad Restrick (Administrative lead) and Kelley Kempski Leadingham (Research program manager).
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