SpineUniverse Technology Highlights from Abbott Neuromodulation, Integra LifeSciences and Integrity Implants

Recharge-Free Spinal Cord Stimulation System Shown Efficacious for Chronic Low Back Pain and Related Psychometrics

Steven M. Falowski, MD, and Allen W. Burton, MD, share their expertise about advances in spinal cord stimulation (SCS) therapy for people living with chronic back pain. The discussion focused on Abbott’s BurstDR™ stimulation waveform, the TRIUMPH clinical study and DISTINCT clinical trial.

BurstDR and Patient-Centric Chronic Back Pain Care
Abbott’s proprietary BurstDR™ stimulation waveform technology is based on scientific insights from doctors and research to mimic natural patterns found in the brain. BurstDR works by using low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain. The company’s Proclaim XR™ recharge-free neurostimulation platform allows physicians to identify the lowest effective dose of BurstDR stimulation for each patient to optimize system longevity while maintaining effective pain relief and eliminates the need for battery recharging (for up to 10 years at low-dose settings*).

Abbott Proclaim XR recharge free neuromodulationAbbott’s Proclaim XR is the recharge-free neuromodulation platform delivering effective low dose BurstDR stimulation. Copyrighted © image made available courtesy of Abbott (Austin, TX).

Dr. Steven Falowski, Director of Functional Neurosurgery at Neurosurgical Associates of Lancaster in Pennsylvania, pointed out how a patient using BurstDR to treat their chronic back pain can benefit compared to traditional tonic SCS.

  • Unlike traditional spinal cord stimulation that creates a gentle tingling sensation, BurstDR waveform is paresthesia-free. No more tingly sensations to remind the patient they live with chronic pain
  • We believe tolerance to therapy can be avoided because BurstDR waveform doesn’t require high energy or constant stimulation to be efficacious
  • BurstDR’s unique physiologic waveform design mimics the way the brain fires affecting pain perception in the prefrontal cortex that can help improve the patient’s mental health
  • Proclaim XR is a non-rechargeable platform that may last up to 10 years*

TRIUMPH Study—Its Unique Design a First
The TRIUMPH study is a prospective, multicenter, single-arm, international study of 269 patients living with chronic back pain.1 This real-world study is the first of its kind designed to evaluate 7 psychometrics—pain catastrophizing, depression, anxiety, fear of movement, quality of life, physical function, and sleep—not just pain. Dr. Falowski presented the published study results at the annual meeting of the North American Spine Society (NASS) in October 2020.2

TRIUMPH study highlights2:

  • At 1 year, 89% of patients achieved a clinically significant improvement in at one of the 7 predefined psychometrics
  • 70% and 72% of patients with clinically significant catastrophizing symptoms at baseline did not display symptoms at 6 and 12 months, respectively
  • 80% and 70% of patients who were showing fear avoidance behavior at baseline were not at 6 and 12 months, respectively
  • 78% and 81% of patients were satisfied or very satisfied with their therapy at 6 and 12 months, respectively
  • 84% and 83% of patients at 6 and 12 months respectively said they would have the BurstDR procedure again

“Looking at the psychometric results, pain catastrophizing stood out. This refers to how you perceive your pain and what it means in your life. Remarkably, the patients with pain catastrophizing in the study improved to the point where they were equal to or better than the healthy non-chronic pain population.1,2 We saw similar improvement in patients with depression who no longer required intervention,” Dr. Falowski said.

“There was not an opioid reduction protocol for this study. However, in this real-world analysis, patients were doing so well that 89% of patients who were taking opioids at baseline decreased or stayed at the same level of opioid use while 19% stopped taking any opioids,” Dr. Falowski added.

DISTINCT Clinical Trial Recruiting
“The DISTINCT study is especially important to help us begin to define a treatment algorithm for patients with severe recalcitrant low back pain that is not responsive to conservative care and patients who are not candidates for spine surgery,” stated Allen W. Burton, MD, Medical Director of Abbott’s neuromodulation business. Considering the TRIUMPH study’s design, psychometrics will be correlated to assess symptoms such as depression in the DISTINCT study.

The DISTINCT study will investigate the efficacy of BurstDR dorsal column stimulation compared with conventional medical management (CMM) in people with chronic low back pain who have not had lumbar spine surgery and for whom spinal surgery is not an option.3 The study will enroll 270 subjects at up to 30 sites in the United States and randomize for spinal cord stimulation (SCS) treatment and CMM, respectively.

After 6 months of treatment in either arm, all participants will be given the option to cross over. This provides an opportunity for subjects in the CMM arm to opt for BurstDR in the open label part of the study.

“The DISTINCT clinical trial is an opportunity to educate surgeons and physicians about Abbott’s Burst DR therapy for their patients living with chronic low back pain who are not considered candidates for spinal surgery. Both Dr. Falowski and I agree BurstDR is uniquely positioned to help these patients live life to the fullest,” Dr. Burton said.

*Up to 10 years of battery longevity at the lowest dose setting: 0.6mA, 500 Ohms, duty cycle 30s on/360s off. NOTE: In neurostimulation therapy, 'dose' refers to the delivery of a quantity of energy to tissue. Safety comparisons and specific dose-response curves for each dosage have not been clinically established. Refer to the IFU for additional information.

Disclosures
Dr. Burton is an Abbott employee. Dr. Falowski is a consultant for Abbott.

References
1. Falowski SM, Moore GA, Cornidez EG, et al. Improved psychosocial and functional outcomes and reduced opioid usage following burst spinal cord stimulation. Neuromodulation: Technology at the Neural Interface. 25 June 2020. Accessed December 2, 2020. https://doi.org/10.1111/ner.13226

2. Falowski SM. The TRIUMPH of BurstDR™ SCS Therapy: Sustained Improvements in Mental, Physical and Emotional Functioning. NASS 2020 Virtual. October 6-9, 2020.

3. Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT). Abbott Medical Devices. Accessed December 2, 2020. https://clinicaltrials.gov/ct2/show/study/NCT04479787

DuraSeal® Exact Spine Sealant System Strengthens Repairs, Supports Healing

Dr. Kee Kim introduced DuraSeal® Exact—a spine sealant formulated for the tighter confines and higher pressures of the spine1 at NASS 2020. DuraSeal Exact is indicated as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.

Dr. Kim’s three-part presentation focused on the history of the DuraSeal® Exact Spine Sealant System (Integra LifeSciences Corporation, Princeton, NJ), its formulation to repair spinal durotomy and prevent CSF leaks, and the product’s safety study. Dr. Kim is Professor and Vice Chair, Chief Spinal Neurosurgery and Co-Director of the Spine Center at UC Davis Health in Sacramento, CA.

Two Formulations Designed with their Specific Indication in Mind
DuraSeal is a polyethylene glycol (PEG) cranial sealant that has been on the market in the United States since 2005. DuraSeal Exact, a low-swell formulation designed for appropriate strength and optimal duration in the spine, was launched in 2011.

DuraSeal Exact’s Mechanism of Action
DuraSeal Exact is a formulation of PEG ester solution and a trilysine amine solution. When mixed together, the liquids crosslink to form an absorbable hydrogel sealant that creates a watertight seal that is sustained during healing.

DuraSeal® Exact Mechanism of ActionDuraSeal® Exact Mechanism of Action illustration provided courtesy of Integra LifeSciences Corporation.

How does DuraSeal Exact differ from DuraSeal Cranial?
Dr. Kim explained the PEG molecule of DuraSeal Exact is fundamentally different as it has 8 arms that are shorter than DuraSeal’s 4 arms.

  • Eight arms mean more intermolecular bonds with significantly shorter intermolecular distances resulting in a more tightly knit seal
  • DuraSeal Exact hydrogel swells 4 times less than the original version of DuraSeal
  • Less swelling translates into practice safety
  • DuraSeal Exact lasts longer in the tight confines of the spine

Over a period of 9 to 12 weeks, DuraSeal Exact’s hydrogel is absorbed and cleared by the kidneys.

DuraSeal Exact Post-Approval Safety Study
“DuraSeal Exact is the only sealant approved for spinal dura repair. When DuraSeal Exact’s low-swell formulation was approved by the FDA in 2011, the approval was contingent on running a large multicenter study to generate real world evidence on the safety profile of employing DuraSeal Exact in spine procedures,” Dr. Kim stated.

This multicenter study was conducted at 36 sites in the United States and enrolled 924 patients into one of two treatment arms: (1) Surgeons used DuraSeal Exact along with any standard of care method or (2) Surgeons applied standard of care methods without the use of DuraSeal Exact.2

Dr. Kim explained, “Because this was a safety study with the intent to collect data on real world clinical practice, there were very few inclusion and exclusion criteria. There were no restrictions on devices in the dural repair and all regions of the spine were studied. The study’s conclusion demonstrated no safety concerns and no adverse events related to swelling when DuraSeal Exact was used.”2

Disclosures
Dr. Kim reports a financial relationship with Integra LifeSciences for certain consulting and educational course services.

Source
Kim KD. CSF leak prevention with a dural sealant designed specifically for spine. North American Spine Society Annual Meeting. October 6-9, 2020.

References
1. Data on file. Integra LifeSciences Corporation.

2. Kim KD, Ramanathan D, Highsmith J, et al. DuraSeal Exact is a safe adjunctive treatment for durotomy in spine: post-approval study. Global Spine J. 2019;9:272-278. Accessed October 29, 2020. https://doi: 2192568218791150

FlareHawk® — A First in the Expandable Cage Space

The fusion efficacy of the FlareHawk® multiplanar expandable interbody cage (Integrity Implants Inc., Palm Beach Gardens, FL) was demonstrated in a series of three peer-reviewed papers recently published in the International Journal of Spine Surgery. The FlareHawk implant is designed using the company’s Adaptive Geometry™ enabling the device to adapt to a patient’s unique endplate anatomy. It represents the first of its kind in the expandable cage market.

FlareHawk’s Expandable Design
Similar to a coronary stent, the FlareHawk expandable cage features a PEEK shell that is inserted in a compressed form that can be passed through neural passageways and expanded once it is within the intervertebral disc space. Device expansion creates a larger footprint, height, and lordosis.

A titanium shim inserted within the PEEK shell produces expansion and creates a solid construct resistant to collapse — yet has shown the potential to conform to a patient’s unique endplate anatomy to increase surface contact area and lower stresses. To date, approximately 8,500 FlareHawk cages have been implanted in more than 6,000 patients.

FlareHawk® multiplanar expandable interbody cageFlareHawk® multiplanar expandable interbody cage image provided courtesy of Integrity Implants Inc.

Novel Aspects of the FlareHawk Device
Boyle C. Cheng, PhD, lead author of Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs reviewed the biomechanical characteristics of these devices and feasibility of FlareHawk.1,2 Dr. Cheng is Professor at Drexel University College of Medicine in Philadelphia, PA, and Director of Research at the Allegheny Health Network (AHN) Neuroscience Institute in Pittsburgh, PA.

  1. FlareHawk’s multi-material, open-architecture design provides a combined spring effect for a modulus of elasticity similar to that of bone while maintaining sufficient support and stiffness from the titanium shim.
  2. Implant geometry allows for the naturally occurring deformation of the PEEK shell to conform to each patient’s endplate configuration.

Dr. Cheng said, “This represents yet another design aspect potentially contributing to the favorable fusion rates seen with the FlareHawk design. In the study, all 18 devices (100%) were determined to have fused based on demonstrated bone growth evidence (average volume of 586.42 mm3) and Bridwell-Lenke classification.2 An interbody device with this unique combination of compliant and rigid components has the potential to conform to the interbody space while maintaining sufficient stability to achieve fusion. This represents a significant advancement not just in expandable cage technology but in the larger context of achieving successful lumbar interbody fusion. The cage appears to conform in shape obliquely, sagittally and coronally, resulting in adaptive implant geometry that surgeons may desire. Additionally, the lack of endplate violation suggests that the FlareHawk cage is an atraumatic implant.”

FlareHawk Safety and Performance Study Outcomes
Principal investigator Domagoj Coric, MD, is the lead author of the study, Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion (TLIF and PLIF); a retrospective evaluation of the safety and performance of expandable devices in TLIF and PLIF procedures.3 Dr. Coric and co-authors Raphael R. Roybal, MD. and Mark Grubb, MD, provide their insights.

The authors evaluated a series of patients at 3 sites who had previously undergone TLIF or PLIF with FlareHawk using only allograft and/or autograft at 1 or 2 contiguous levels between L2 and S1.3 The 58 study participants included patients with high body mass index (BMI), diabetes and current/former smokers.

  • Among subjects with radiographs at 12 ± 3 months, nearly all achieved fusion based on the Bridwell-Lenke classification: 56 of 58 patients (96.6%) and 75 of 77 levels (97.4%)
  • Among 45 patients, 32 (71%) achieved clinically significant improvements in VAS leg pain and 34 patients (76%) achieved clinically significant improvements in VAS back pain
  • No (0%) reported device-related adverse events (AEs)
  • No (0%) observed cage subsidence
  • One case (1.7%) observed cage migration (the cage moved slightly within the disc space and the patient went on to fuse)

Dr. Coric observed, “This study adds to the evidence base supporting the safe and effective use of expandable interbody spacers in the treatment of lumbar spine diseases. The FlareHawk implant’s ability to expand in both cephalad-caudal and lateral-medial planes is especially advantageous for decreasing neural retraction while maximizing vertebral body endplate coverage and fusion area. Dr. Coric is Chief of Neurosurgery at Carolinas Medical Center, Spine Division Chief at Atrium Musculoskeletal Institute and in practice at Carolina Neurosurgery & Spine Associates in Charlotte, NC.

Additional Key Takeaways
Raphael Roybal, MD, said, “Popular minimally invasive TLIF techniques, typically involving a unilateral approach to the disc space, may limit the amount of disc space preparation and/or bone graft delivery, thereby impeding fusion rates. Biplanar expandable spacers that support minimally invasive surgery, safer implantation, and optimal patient outcomes will be relevant in delivering value-based spine care.” Dr. Roybal is Director of The Spine Institute at Chatham Orthopaedics in Savannah, GA.

Mark Grubb, MD, commented, “Most expandable spacers use complex articulation mechanisms to expand the implant profile in either height or width but typically do not achieve multidirectional expansion. Furthermore, these complex mechanisms can limit the space available for bone grafting. I appreciate the FlareHawk cage features a small insertion profile and expands in footprint, height and lordosis via an unobtrusive mechanism that allows me to deliver bone graft through the expanded cage and into the intervertebral body space. Additionally, the ability to treat my patients via a single-position, posterior surgery allows me to improve both the quality and efficiency of my practice.” Dr. Grubb is a minimally invasive spine surgeon at Northeast Ohio Spine Center in Akron, OH.

Disclosures
The surgeons quoted in this article may have financial relationships with Integrity Implants for certain consulting and development services.

References
1. Cheng BC, Swink I, Yusufbekov R, et al. Current concepts of contemporary expandable lumbar interbody fusion cage designs: An editorial on their biomechanical characteristics, Part 1. IJSS. 2020;10;7128. Accessed November 17, 2020. https://doi.org/10.14444/7128

2. Cheng BC, Swink I, Yusufbekov R, et al. Current concepts of contemporary expandable lumbar interbody fusion case designs: Feasibility assessment of an endplate conforming bidirectional expandable interbody case, Part 2. IJSS. 2020:10:7129. Accessed November 17, 2020. https://doi.org/10.14444/7129

3. Coric D, Roybal RR, Grubb M, et al. Bidirectional expandable technology for transforaminal or posterior lumbar interbody fusion: A retrospective analysis of safety and performance. ISJJ. 2020;10:7123. Accessed November 17, 2020. https://doi.org/10.14444/7123
 

Updated on: 12/28/20
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Spinal Cord Stimulation’s Place in the Pain Treatment Continuum and Advancements in Technology
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