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FDA approves IDE for take-home trial using the DEKA LUKE prosthetic arm and Utah Slant Array : Participants will be able to take home the dexterous bionic hand which they can feel in next phase of research

Sep 26, 2020

SALT LAKE CITY, UT (September 22, 2020) — Blackrock Microsystems would like to congratulate the University of Utah Biomedical Engineering Department on receiving FDA approval to initiate their investigational device exemption (IDE) study for their next evolution of peripheral nerve studies using the Utah Slant Array (also known as USEA) under the HAPTIX program.  The Defense Advanced Research Projects Agency (DARPA) program from their Biological Technology Office (BTO) is pursuing key technologies to enable precision control of and sensory feedback from sensor-equipped upper-limb prosthetic devices. With FDA approval for further peripheral nerve research using the Slant Array, a take-home trial will begin investigating whether the University of Utah’s prosthetic arm system improves amputees’ performance of activities of daily living.


At the core of these studies is the Slant Array, which is the peripheral nerve cousin to the Utah Array – the gold standard for human central nervous system recording since 2004 and stimulation since 2015. Until now, all human peripheral nerve studies using the Slant Array under the HAPTIX program have taken place in the lab using the DEKA LUKE Arm, a prosthetic device with multiple powered joints and sensors. The team has spent several years developing the technology that controls the motor control and sensory feedback delivered to the amputee through the Slant Array. It is their goal to make the control and feedback as realistic as possible. Previous work has shown that the Slant Array can create natural sensations, and the sensory feedback enhances interaction with the prosthesis in a meaningful manner.


Loren Rieth, Ph.D., Associate Professor at the Feinstein Institutes for Medical Research and Adjunct Associate Professor of the Biomedical Engineering Department says, “This study would not have been possible without development helical leads, tip metal improvements, truly countless SEM images and characterization of truly countless arrays allowing the devices to perform well for up to 17 months with past participants.”  He continues, “Ranging from substantially improved [Slant Arrays] that provide unprecedented biomimetic activation of cutaneous percepts and greatly increased long-term functionality, to [Blackrock Microsystems’] assistance with obtaining regulatory approval, these have been absolutely essential in advancing the field of neural prosthetics.”


The Slant Array is the electrode interface array for peripheral nerve applications due to varying electrode lengths across the array, and the ability to utilize up to 300 individual electrodes (3 Slant Arrays) for these studies.  The varying electrode length allows more selective stimulation and recording of fascicles with the nerve when compared to conventional cuff electrodes.  The University of Utah team, led by Associate Professor Gregory Clark, mentions many broader applications of the Slant Array, “Experimental successes and regulatory approvals associated with HAPTIX may facilitate progress and approvals of Slant Arrays for other peripheral nervous system uses that are already being explored experimentally, such as for auditory nerve implants to provide improved hearing, motor nerve stimulation for reanimating paralyzed limbs after spinal cord injury or stroke, bladder control, or pain mitigation.”  He further adds, “Because peripheral nerves innervate almost every body part and organ system, there are multiple opportunities to provide clinical benefits for a wide variety of disorders or diseases.”


“The initial success the UofU has had in this field is precisely what government funds should support, it is crucial financial funding we need to translate an innovation technology such as this into a clinical application to benefit patients”, says Marcus Gerhardt, CEO of Blackrock Microsystems. The University of Utah Biomedical Engineering Team will begin their FDA-approved take-home phase of the research, testing how the prosthetic LUKE Arm with the Slant Array for sensory feedback functions in real world settings. The advancements of this research will benefit millions of people living with limb loss, as the HAPTIX program continues its mission of restoring function and feeling. 


Blackrock Microsystems, based in Salt Lake City, Utah, was founded in 2008 and is the world’s leading provider of technology in the neuroscience, neural engineering, and neural prosthetics space. The company’s technology is at the core of worldwide innovations in Brain-Machine Interfaces (BMI/BCI), implantable bionic technologies and epilepsy diagnostics. Most impactful implantations of the Utah Array have been in some tetraplegic individuals from University of Pittsburgh’s Nathan Copeland, who controlled a prosthetic arm to fist bump US President Barack Obama in 2016; Ohio State University’s Ian Burkhart who is learning to control an automobile, and CalTech’s Nancy Smith who is learning to play a virtual piano. Seemingly easy tasks, all have used the Utah Array to translate their thoughts into action to restore function