Medical Device Network

FDA grants breakthrough designation for Blue Arbor’s RESTORE System

The RESTORE System can connect to a patient’s residual muscles and peripheral nerves, surpassing skin electrode technologies.

The US Food and Drug Administration (FDA) has granted breakthrough device designation for Blue Arbor Technologies's RESTORE Neuromuscular Interface System.

This milestone marks a step forward in the integration of the peripheral nervous system with robotic prosthetics, aiming to restore natural hand and arm functions for individuals with upper limb loss.

The RESTORE System, which has also been accepted into the FDA’s Total Product Life Cycle Advisory Program Pilot (TAP Pilot), is poised to revolutionise the way prosthetic devices are controlled.

By providing a direct connection to the patient’s residual muscles and peripheral nerves, the system is claimed to offer reliable and voluntary movement control signals, surpassing the capabilities of current surface skin electrode technologies.

With the ability to enable simultaneous and independent movement of finger, wrist, and elbow joints, it can offer a higher level of control compared to existing prosthetic interfaces.

The RESTORE System's design has demonstrated consistent motor signal capture for more than five years in early feasibility human studies.

The FDA Breakthrough Devices Program aims to fast-track the evaluation and review of medical devices that offer significant advancements in treatment for life-threatening or irreversibly debilitating conditions.

Blue Arbor Technologies president Paul Cederna said: “Blue Arbor Technologies is dedicated to developing solutions that address the unmet need for improved robotic prosthetic control options for people with limb loss so they can more easily integrate a prosthesis in their daily lives and return to normality.

“The breakthrough designation and TAP enrolment is a valuable step in the pathway to FDA market clearance. We look forward to working closely with the agency to make the RESTORE System available to people with upper limb loss to hopefully increase prosthesis adoption and use.”

The investigational neuroprosthetic interface comprises implantable intramuscular electrodes, a sensing unit, a socket-mounted receiver and a software package.