SpineUniverse Technology Highlights NeuroSphere™ myPath™, G-scan Brio Dedicated MRI and Up-LIFT Clinical Trial

How NeuroSphere™ myPath™ Optimizes Digital Patient-Connected Care

Abbott is working to make digital and remote health options available to better connect providers and patients across all of its therapies, including neuromodulation devices. To make neuromodulation therapy as personalized as possible, Abbott is also exploring game-changing advancements in battery life, waveform types, stimulation targets and connectivity.

In May 2020, Abbott launched the NeuroSphere™ Digital Care connected care management platform, which is designed to optimize care for chronic pain and movement disorders. The timing was right—in the midst of the pandemic—to ensure Abbott is keeping up with the needs of patients and physicians.

This includes apps (eg, Patient Controller app, myPath™ app) that can be directly downloaded on a patient’s smartphone to help them control their therapy, objectify their condition, track/report pain and interact with their care team from anywhere in the world.

Abbott's NeuroSphere myApp screenshotsAbbott’s NeuroSphere™ myApp™ home and sample my data screenshots. Image used with permission. © Abbott 2021.

In January 2021, Abbott announced the upcoming launch of NeuroSphere™ myPath™—a digital health app patients use to report and track perceived pain relief and overall well-being (eg, sleep, anxiety, depression) while trialing spinal cord stimulation (SCS) or dorsal root ganglion (DRG) neuromodulation therapy. It is compatible with Abbott’s Proclaim™ XR SCS System and Proclaim™ DRG Neurostimulation System.

NeuroSphere myPath is the latest innovation that fits Abbott’s broader NeuroSphere Digital Care health management platform for chronic pain or movement disorders. “We believe myPath, as part of the patient’s neuromodulation trial experience, will quickly set a new standard of care—and become a must have digital tool,” said Allen W. Burton, MD. Dr. Burton is Medical Director of Abbott’s neuromodulation business.

The impact of COVID and the subsequent pandemic lifestyle changed traditional physician/ patient face-to-face relationships to include new digital alternatives. Pankaj Mehta, MD, Chief Medical Officer of Pain Specialists of Austin, said “While we were able to communicate with our neurostimulation patients via telemedicine it was difficult to trouble shoot problems and track their wellness improvements. The myPath app is great and provides direct communication that’s essential when a patient ‘test drives’ spinal cord stimulation therapy.”

“In my space as an interventional pain management specialist, I’m excited about the myPath app because it will allow me to track and collect reportable data from patients receiving spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapies, particularly during the trialing and long-term implant phases,” said Shachi Patel, MD. Dr. Patel is an Interventional Pain Management Physician and Owner of Delmarva Pain and Spine Center in Newark, DE.

Dr. Patel also said, “The other side of providing optimal patient care is contending with insurance companies for prior authorization and coverage of treatments clinicians view as necessary to avoid chronic opioid medications. The NeuroSphere myPath app provides—in a very granular form—the patient’s data through the PROMIS® (Patient-Reported Outcomes Measurement Information System) questionnaire. The data collected through myPath provides a clear picture of the patient’s SCS or DRG trial experience and is useful to support and validate our treatment recommendations for prior authorization and reimbursement.”

“Right now, the missing element in the market that myPath fulfills is real-time access to data once the patient leaves our clinic that keeps us informed how the patient is doing. The app enables the patient to engage with their clinician and the Abbott team affording opportunities to optimize their pain therapy. We can avoid wasting a trial by intervening early and taking necessary steps to achieve a successful SCS or DRG trial,” said Dr. Patel.

Disclosures
Dr. Burton is an Abbott employee. Dr. Mehta on the advisory board of Vertiflex, and is a consultant and faculty for the educational curriculum for Vertiflex, Abbott, SPR Therapeutics and Ethos Labs (functional biomarkers). Dr. Patel is a consultant for Abbott.

Sources
Abbott Receives FDA Approval for iOS-Compatible App Allowing People Living With Chronic Pain and Movement Disorders to Personalize Therapy Via Their Mobile Device (July 23, 2020).  https://abbott.mediaroom.com/2020-07-23-Abbott-Receives-FDA-Approval-for-iOS-Compatible-App-Allowing-People-Living-With-Chronic-Pain-and-Movement-Disorders-to-Personalize-Therapy-Via-Their-Mobile-Device

Abbott to Launch the NeuroSphere™ myPath™ Digital Health App Designed to Track and Report Pain Relief in Chronic Pain Patients With Physicians Prior to Device Implant (January 14, 2021).  https://abbott.mediaroom.com/2021-01-14-Abbott-to-Launch-the-NeuroSphere-TM-myPath-TM-Digital-Health-App-Designed-to-Track-and-Report-Pain-Relief-in-Chronic-Pain-Patients-With-Physicians-Prior-to-Device-Implant

Esaote G-scan Brio Uses Gravity to Add Weight to Your Diagnosis

Advanced weight-bearing magnetic resonance imaging (MRI) technology is challenging conventional MR imaging and diagnostic platforms. The Esaote G-scan Brio Dedicated MRI system’s unique tilting design easily rotates the patient from supine into a true weight-bearing position (from 0 to 90-degrees).

Esaote G-scan Brio Dedicated MRI SystemThe Esaote G-scan Brio Dedicated MRI system affords patients an open-concept and weight-bearing MR imaging experience. Image provided courtesy of © Esaote North America.

Weight-Bearing MRI Can Add Diagnostic Value
Weight-bearing MR imaging yields more diagnostic information necessary to evaluate musculoskeletal disorders affecting the spine, hips, and joints. Esaote’s G-scan Brio weight-bearing MRI options reveal pathologies subject to change during axial loading—like back pain caused by lumbar spinal stenosis or spondylolisthesis.

The G-scan Brio offers both supine and weight-bearing MRI studies for comparison and demonstrates the pathology related to a patient’s particular symptoms. Normally, the patient is imaged first in the upright weight-bearing position and then in the traditional supine position to make differential diagnosis possible.

“Advanced imaging is important to patient care … Esaote’s weight-bearing technology has been a game-changer in our community,” said Dr. James Lynch during a recent webinar. “Weight-bearing MRI may increase the diagnostic sensitivity of nerve root compression in cases of lumbar disc herniation,1,2” he said. James J. Lynch, MD, FACS, FAANS, is a minimally invasive neurosurgeon and founder of SpineNevada in Reno.

Open-Concept Design Helps Relieve Patient Anxiety
“The G-scan Brio design is an open concept that reduces the risk for claustrophobia in some patients. I’ve seen patients feel relieved when they come into our office, turn the corner and see the G-scan is open knowing they are not going to be placed into a closed and confined tube,2” said Cesar Cuevas, Chief Executive Officer and President of Stat Diagnostics in Houston, TX. G-scan’s open configuration provides patients and adolescents a more positive imaging experience.

One Room In-Office Installation
The G-scan Brio is a one room MRI system with a very small footprint allowing for in-office installation of the magnet, electronics, and console—and it can run from a conventional power outlet—unlike most MRIs. This adds up to making supine and weight-bearing MRI more accessible to patients while offering a high-quality imaging solution.

In-office MRI allows greater continuity of patient care as the imaging examination may be performed the same day as the clinic visit. With increased interest and adoption of the G-scan Brio weight-bearing MR imaging technique, changes to patient treatment can be considered, and that may lead to more conservative intervention rather than more disruptive invasive solutions.

Disclosures
Dr. Lynch and Mr. Cuevas have no disclosures to report related to the webinar.

References
1. Nordberg CL, Boesen M, Fournier GL, Bliddal H, Hansen P, Hansen BB. Positional changes in lumbar disc herniation during standing or lumbar extension: a cross-sectional weight-bearing MRI study. Eur Radiol. 2021;31:804–812. Accessed February 12, 2021. https://link.springer.com/article/10.1007%2Fs00330-020-07132-w

2. Lynch JJ, Cuevas C. How Dedicated Weight-Bearing Imaging Improves Patient Care. In collaboration with Esaote North America. Webinar. January 21, 2021.  https://www.beckersasc.com/asc-quality-infection-control/how-weight-bearing-mris-can-improve-patient-care-2-experts-weigh-in.html

Sources
G-scan Brio. The Key to Confidence (Product Brochure) Esaote North America. Accessed February 12, 2021. https://www.esaote.com/uploads/tx_esaotedocuments/GscanBrio_169008500MA_V08_LR.pdf

Fiani B, Griepp DW, Lee J, Davati C, Moawad CM, Kondilis A. Weight-bearing magnetic resonance imaging as a diagnostic tool that generates biomechanical changes in spine anatomy. Cureus. 12(12): e12070. doi: 10.7759/cureus.12070. Accessed February 12, 2021. https://www.cureus.com/articles/46597-weight-bearing-magnetic-resonance-imaging-as-a-diagnostic-tool-that-generates-biomechanical-changes-in-spine-anatomy

Nordberg CL, Hansen BB, Nybing JD, Hansen P, Bliddal H, Griffith JF, et al. Weight-bearing MRI of the lumbar spine: technical aspects. Semin Musculoskelet Radiol. 2019;23(6):609-620. doi: 10.1055/s-0039-1697936. Accessed February 12, 2021. https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0039-1697936

Michelini G, Corridore A, Torlone S, Bruno F, Marsecano C, Capasso R, et al. Dynamic MRI in the evaluation of the spine: state of the art. Acta Biomed. 2018;89(1-S):89-101. doi: 10.23750/abm.v89i1-S.7012. Accessed February 12, 2021. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6179074/

Up-LIFT Pivotal Clinical Trial Enrolls First Patient in Study to Improve Upper Extremity Function Post Cervical SCI

ONWARD (formerly GTX Medical) recently announced the first patient has been enrolled in the company’s pivotal clinical trial evaluating its ARC Therapy™ — targeted, programmed stimulation of the spinal cord to improve upper extremity function and quality of life in people with spinal cord injury (SCI).

“The start of this trial marks a significant milestone in bringing noninvasive stimulation to people living with spinal cord injury whose top priority is restoring hand and arm function,” said Chet Moritz, PhD. Dr. Moritz is the trial’s Co-Principal Investigator and Associate Professor in the Departments of Electrical & Computer Engineering and Rehabilitation Medicine at the University of Washington in Seattle.

ONWARD ARC EX TherapyARC-EX (External) Therapy is administered using the LIFT System. Image provided courtesy of ONWARD

Up-LIFT Pivotal Clinical Trial—Overview
The Up-LIFT Study is a prospective, single-arm study designed to evaluate the safety and effectiveness of ONWARD’s ARCEX Therapy. ARCEX Therapy is noninvasive electrical spinal cord stimulation (SCS) administered by the LIFT System to treat upper extremity functional deficits in people with chronic tetraplegia.1 The Therapy is designed to re-establish severed connections between spared neural networks and the brain by means of specific targeted SCS.

ONWARD plans to enroll 65 subjects at up to 15 sites in the United States, Canada, United Kingdom and Europe. “The initiation of the Up-LIFT trial is an important first step toward delivering meaningful solutions to people living with spinal cord injury,” said Dave Marver, ONWARD’s Chief Executive Officer.

Remarkable SCI Research Strives to Improves Lives
Dr. Moritz co-authored a recently published study that demonstrated transcutaneous spinal cord stimulation leads to both rapid and sustained recovery of hand and arm function for people with both motor complete and incomplete cervical SCI.2 He commented, “Stimulation therapy is remarkable in that it can restore hand function even to people with no movement of their hands and fingers, as well as substantially increase strength and function for people many years after spinal cord injury. We have seen the benefits of people return to their complex hobbies such as playing the guitar, even after 12 years of not using one of their hands in any daily activities.”

Jessie, a research study participant, who worked with Dr. Moritz, said, “I was surprised to see results that made an impactful difference in my daily life … within a few weeks, I found the stimulation increased the function in my hands … this study has helped me make significant changes in my life. I now receive 50% less caregiving … I was able to buy a house and live in it independently. I am able to reach with a greater range of physical skills, and I can cook and prepare meals for myself. Maybe the most fun effect was that I was able to snag myself a super handsome husband! Was that a direct effect from the study? Maybe. It did however give me the confidence to go out there and shoot my shot. I will forever be thankful to the team that allowed me to be a part of this great advance in spinal cord injury recovery.”

Jessie is featured in this YouTube video: https://www.youtube.com/watch?v=Dp9J4j2uWrI&feature=youtu.be

ONWARD’s Next Steps
Both ARCEX (external) and ARCIM (implantable) devices received the Food & Drug Administration’s (FDA) Breakthrough Device designation as truly innovative and worthy of an accelerated pathway to approval making this technology more readily available to patients who may benefit. “We are hopeful the ARCEX Therapy will receive FDA clearance and become available by 2023. Also, we are hopeful our ARCIM implantable platform will commence US pivotal trials in 2022,” said Marver.

“An important benefit of the Breakthrough Device Designation is a coverage pathway called Medicare Coverage of Innovative Technology (MCIT). This means the Centers for Medicare & Medicaid Services (CMS) may guarantee reimbursement for our breakthrough therapies for the first 48 months following approval or clearance,” commented Marver.

Marver’s closing thoughts — “As a company, ONWARD’s sole purpose is to develop technologies that can help people with SCI enjoy life in every way that matters to them. In addition to restoring movement, we have observed other potential benefits from SCS that we may explore such as improved bladder control, sexual function, and blood pressure regulation.”

Devices are investigational and not approved for commercial sale.

Disclosures
Dr. Moritz has no disclosures to report.

References
1. The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury (Up-LIFT). https://clinicaltrials.gov/ct2/show/NCT04697472

2. Inanici F, Brighton LN, Samejima S, Hofstetter CP, Moritz CT. Transcutaneous spinal cord stimulation restores hand and arm function after spinal cord injury. IEEE Transactions on Neural Systems and Rehabilitation Engineering. 05 Jan 2021. doi: 10.1109/TNSRE.2021.3049133. https://ieeexplore.ieee.org/document/9314097
 

Updated on: 05/03/21
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