SpineUniverse Technology Highlights from Bioventus, Mainstay Medical and Spinal Balance

FDA CLEARED: Synergetic Bioactive Bone Graft Strips Jump Start Spinal Fusion

Bioventus, LLC recently announced FDA clearance of its SIGNAFUSE® Bioactive Bone Graft in a strip format. The company indicated the product will be available in the United States during Q3 of 2020.

“We are excited to have this product on the market and I think it’s representative of the company’s move to in-house innovations and development,” said Larry Boyd, PhD, Vice President of Product Development.

Dr. Boyd joined Bioventus about 18 months ago after 30 years of experience leading medical product development and engineering of orthopedic and spinal devices. “I’m glad to be on board with Bioventus; it’s a great fit,” he said. Orthopedic biomaterials including growth factors, synthetic bioactive bone grafts and human allograft are areas of special interest to Dr. Boyd.

“The strip format is an extension of our existing SIGNAFUSE platform with well-evidenced history,” said Dr. Boyd. “The putty handles really well for certain applications and is a good extender when mixed with autogenous or allograft bone, but now having absorptive moldable and pliable strips gives surgeons one more way to use this well-established bioactive synthetic bone graft,” Dr. Boyd stated.

Bioventus SIGNAFUSE Bioactive Bone Graft StripSIGNAFUSE® Bioactive Bone Graft in a strip format. Image use courtesy of Bioventus, LLC.

Each SIGNAFUSE strip is a collagen-based absorbent sheet that is 8 mm thick providing good material volume for bone grafting. “It handles really well and doesn’t fall apart when soaked in autogenous bone marrow aspirate [BMA] as indicated,” Dr. Boyd said.

Another advantage is that the strips come in a range of size lengths from 25 mm to 200 mm. The strip size diversity is appealing to surgeons and affords them an effective and efficient bone graft substitute for their multilevel fusion procedures.

Khoi D. Than, MD, a neurosurgeon at Duke Spine Center commented, “The strips have the potential to help surgeons accomplish robust fusions, particularly with open cases. I like the variety of length offerings, which can help surgeons whether they’re doing a 1-level fusion or a 15-level fusion.”

The SIGNAFUSE bioactive bone graft is a proprietary blend of biphasic mineral granules composed of 60% hydroxyapatite and 40% β-tricalcium phosphate, a ratio supported by clinical data1-3 and patented bioactive glass particles. It creates a synergistic triad effect when used with BMA —a bioactive platform that is osteoconductive, osteoinductive and osteogenic that jump starts4 the fusion process.

Disclosure
Dr. Than is a Consultant for Bioventus, LLC.

References
1. Ransford AO, Morley T, Edgar MA, Webb P, et al. Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients. J Bone Joint Surg Br. 1998;80-B:13-8. doi: 10.1302/0301-620x.80b1.7276

2. Delécrin J, Takahashi S, Gouin F, Passuti N. A synthetic porous ceramic as a bone graft substitute in the surgical management of scoliosis: a prospective, randomized study. Spine (Phila Pa 1976). 2000;25(5):563-9. doi: 10.1097/00007632-200003010-00006

3. Pascal-Moussellard H, Catonné Y, Robert R, Daculsi G. Anterior cervical fusion with PEEK cages: clinical results of a prospective, comparative, multicenter and randomized study comparing iliac graft and a macroporous biphasic calcium phosphate. Spine J. 2006;6(suppl 5):136S. Abstract P109. doi: 10.1016/j.spinee.2006.06.318

4. Brunelle JE, Seaman SA, Davis CT, Tom S. In vitro and in vivo characterization of SIGNAFUSE Bioactive Bone Graft. Data on file. Bioventus white paper, 2017.

NEW PAIN TECHNOLOGY: Restoring Control of Chronic Low Back Pain

Chronic low back pain (CLBP) affects a huge number of people worldwide and is a top cause of widespread economic burden. A “non-specific” or “mechanical” pain diagnosis often is a consequence of CLBP, and many patients have exhausted treatment options.

But that’s changing. Mainstay Medical’s ReActiv8® offers some patients new hope based on restorative therapy, not palliative care.

New Class of Spinal Neurostimulation Specific to Multifidus Muscle Dysfunction
Mainstay Medical recently announced the US FDA’s approval to market the company’s ReActiv8 implantable neurostimulation system designed to treat intractable chronic low back pain associated with multifidus muscle dysfunction.

“ReActiv8 represents a new class of neurostimulation for many patients who have run the course of available treatments without successful resolution of their pain,” stated Jason Hannon, Mainstay Medical’s CEO.

Mainstay Medical ReActiv8 Chronic Low Back Pain therapyImage use courtesy of Mainstay Medical.

“Our research found that in more than 80% of patients with CLBP their MRI studies revealed the multifidus muscle had been heavily infiltrated with fat, leading to muscle dysfunction and lumbar instability,1” Mr. Hannon said. The multifidus muscle is key to lumbar stabilization2 and ReActiv8 is designed to stimulate select lumbar nerves to cause contractions of the multifidus muscle and restore stabilizing muscular function.

Possible Relief from CLBP
On average, patients with CLBP have suffered for 10-15 years and tried everything—pain medications, physical therapy, injections, nerve blocks and/or radiofrequency ablation—all without success.

“As Dr. Christopher Gilligan, who is the principal investigator on our study said, ‘At this level none of these patients are going to spontaneously resolve pain or just get better. They will deal with this forever’”, said Hannon.

“Physicians are excited about the ReActiv8 treatment option for their patients with intractable, mechanical CLBP. These patients have been to doctors for years, failed physical therapy and are not candidates for traditional neurostimulation or spine surgery,” Hannon continued.

No Device Trial Needed
Unlike spinal cord stimulation, no trial is required prior to ReActiv8 device implantation. Hannon explained why. “Contraction of the multifidus muscle is confirmed intraoperatively—essentially, the leads are connected to an external power source, multifidus muscle contraction is validated, and the generator implanted.”

The patient activates the wireless hand-held generator 30 minutes in the morning and at night. During a 30-minute therapy, stimulation of the nerve causes repetitive smooth contraction of the multifidus muscle. Some patients describe the feeling as a no-touch massage. “The ReActiv8 therapy is progressive and patients have a high response rate. About 75% of patients continue to respond positively with therapy at a year,” stated Hannon.

Restoring Lives—Kate’s Story
“I was in London before the COVID quarantine and had the opportunity to meet a ReActiv8 patient. Kate, a response team police officer, was forced to a desk-based job because of her chronic low back pain,” said Hannon.

For three years Kate was unable to manage her pain and described how pain had overtaken her life leading her to becoming reclusive. “Her pain physician recommended ReActiv8 and 12 months later, Kate fully resumed her life and recently completed a marathon. Now that’s an incredible outcome,” said Hannon.

Hannon indicated that Mainstay Medical expects to begin marketing in the United States the first half of 2021. Physicians can feel comfortable knowing ReActiv8 already fits an existing reimbursement code.

References
1. On-going clinical trial results. ReActive8 implantable neurostimulation system for chronic low back pain (ReActive8-B). https://www.mainstay-medical.com/us/clinicians/studies

2. Hebert JJ, Koppenhaver SL, Magel JS, Fritz J.M. The relationship of transversus abdominis and lumbar multifidus activation and prognostic factors for clinical success with a stabilization exercise program: a cross-sectional study. Arch Phys Med Rehabil. 2010;91(1):78-85. https://www.archives-pmr.org/article/S0003-9993(09)00754-0/fulltext

TECHNOLOGY Q&A: No-Touch Technology Tackles Spinal Implant Contamination

Pedicle screw and orthopedic implant contamination is well-evidenced by research as a cause of infection after spine surgery. We spoke with Aakash Agarwal, PhD, about the scope of the problem, his personal viewpoints and the “No-Touch Technology” solution Spinal Balance Inc. offers. Dr. Agarwal is the company’s Director of Research and Clinical Affairs.

Spinal device biofilmImage use courtesy of Spinal Balance Inc.

When did the company get its start and who is behind Spinal Balance innovations?

Dr. Agarwal: Spinal Balance Inc. started in 2014 with the mission to trailblaze the spinal and orthopedic industry towards avoiding all modes of contamination that a standard implant undergoes, such as repeated reprocessing and exposure during surgery. The company has been successful in reshaping the industry by garnering substantial clinical and technical evidences that brought to light these major breaches hampering patient safety.

The company has multiple founding members, a dedicated team, and several early investors, who were all equally responsible for the launch of the “No-Touch” pedicle screw system in 2017 under the vision set by Anand Agarwal, MD, President and CEO of Spinal Balance Inc.

What does Spinal Balance want surgeons to know?

Dr. Agarwal: We understand the life of a spine surgeon is nothing short of altruism, considering the mission behind his or her practice is the safety and wellbeing of their patients. A single surgeon and his or her team handles every step taken before, during and after spine surgery to help guarantee patient safety.

Although they have been trying their best to mitigate all known modes of failure and potential postoperative complications, such as infection—early, delayed, or late onset—sub-chronic biofilm and implant failure, I would like them to consider reviewing everything the team of Spinal Balance Inc. has put forth to reduce the existing breach in patient safety.

How informed are surgeons about device contamination?

Dr. Agarwal: Surgeons are aware of contamination and its nefarious nature in affecting patient wellbeing. Today, we know more than what we knew yesterday, and it is a humbling realization to say the least. To gain a complete understanding about implant contamination and the consequences, it’s necessary to consider all the latest clinical and technical findings published and widely available in peer-reviewed journals and by Spinal Balance’s team.

Please explain NT2 — No-Touch Technology.

Dr. Agarwal: NT2 refers to the company’s proprietary implant guard, “No-Touch Technology” is integral to its Libra® pedicle screw system. In brief, Spinal Balance’s pedicle screw system is delivered to theatre in individual pre-sterile tubes avoiding reprocessing. Inside each tube is a pedicle screw enclosed in a clinically proven implant-sheath that guards against all forms of physical exposure in the sterile field until the surgeon is ready to implant the device.

This means implants are not touched during loading—attaching the implant to the insertion device—from anyone, such as a scrub tech. Also, the implant doesn’t come into contact with any in-use instruments or surfaces in the sterile field.

Furthermore, the pre-sterile tube has been shown to be superior to traditional blister packs, peel-pouches, and boxes in three ways:

  1. The pre-sterile tube avoids punctures or breaches in the sterile barrier common with traditional packaging systems.
  2. It takes only a few seconds to access each implant.
  3. It provides stable access to the implant and helps avoid accidental drops or inadvertent exposure outside the sterile field.

The implant-sheath has Level-II clinical evidence demonstrating absence of contamination in contrast to implants provided without a sheath.

Why do you say the “Spinal Balance solution is turnkey”?

Dr. Agarwal: The surgeon doesn’t need to change his or her technique or how they perform spine surgery. The implants are delivered surgery-ready meaning the hospital doesn’t need to reprocess these implants—a key source known to cause contamination. Both cost and liability can be reduced.

Spine and orthopedic industry members can convert all their orthopedic implants to our proprietary No-Touch Technology by licensing or purchasing rights to the technology; both the tubes and sheaths.

Issues surrounding reprocessing pedicle screws and implants is a focal point of your research. What’s next?

Dr. Agarwal: There exists an irrefutable dossier of evidence against reprocessing pedicle screws, or any other orthopedic implants for that matter. The health department of Scotland banned it a decade ago, and while other countries like Japan, Australia and the Netherlands are currently in transition, I filed a petition with the United States FDA to do the same. The longer this petition takes to approve, the longer public health is put at risk. There is not scientific or ethical ground to disapprove it, and if it is disapproved, it simply goes against the FDA’s mission.

In your opinion, has the pandemic caused surgeons to reconsider their choices?

Dr. Agarwal: This breach in safety for patients undergoing spine surgery is outrageous, with or without the pandemic. I hope the pandemic does bring forth new realizations and sobriety to healthcare in general.

However, unless spine surgeons, hospitals, and industry members bring themselves to assimilate the dossier of clinical evidences Spinal Balance has put forth, they still don’t have a choice to make. I would implore spine surgeons, industry members and hospitals to come together and work towards transitioning to “truly sterile” spine surgery.

Updated on: 07/28/20
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