Performance Summary

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Evidence-based performance summary on FzioMed's adhesion barrier gel for lumbar spine surgery (available under the brand names Oxiplex®, Oxiplex®/SP and MediShield™). Information provided is summarized from published literature or presentations. Refer to citations for complete data.

Evidence for reduction of leg and back pain1,2,3,4

Indication for Surgery

Laminectomy, laminotomy, discectomy (352 patients)

Method / Material

352-patient multi-center, randomized, controlled, blinded U.S. pivotal trial. Surgery for unilateral herniation of lumbar disc at L4-L5 or L5-S1. Patients treated with surgery plus Oxiplex gel (N=177) or surgery alone (N=175).

Results / Conclusion

Patients with severe baseline back pain treated with surgery plus Oxiplex gel had statistically significant reduction in leg and back pain at six months post-surgery compared to controls (Oxiplex n=78 vs Controls n=78).

Evidence for safety5

Indication for Surgery

Lumbar discectomy (396 patients)

Method / Material

396 patients treated with Oxiplex gel over 3-year period (January 2003 thru December 2005) were evaluated for side effects such as skin reactions, general reactions and reoperations.

Results / Conclusion

No product related complications were observed. In five patients needing reoperations for recurrent herniation, significant but subjective reduction in fibrosis was observed at second surgery. Gel was well tolerated as an agent to achieve reduction of fibrosis in lumbar disc surgery.

Evidence for reduction of leg pain and disability scores6

Indication for Surgery

Posterior lumbar microdiscectomy for disc herniation (70 patients)

Method / Material

Consecutive series of 70 patients undergoing surgery for unilateral herniation of lumbar disc at L3-L4, L4-L5, or L5-S1 treated with CMC/PEO gel (n=35) or without gel (n=35). Patients assessed before surgery and regularly over three years post-surgery, for disability using Oswestry Disability Index (ODI) and for leg and back using Visual Analog Scale (VAS).

Results / Conclusion

In 3-year follow-up, CMC/PEO gel significantly reduced disability and leg pain scores compared with conventional treatment (no gel). CMC/PEO gel was found to be safe to use, easy to apply and required minimal additional surgical time.

Evidence for reduction of epidural fibrosis in lumbar surgery with normal bone healing7

Indications

Laminotomy and laminectomy model (rabbit)

Method / Material

Two laminotomy or laminectomy sites per animal at L4 and L6. Sites treated with compositions of CMC/PEO gels or films and compared to control sites (no gel).

Results / Conclusion

Direct visualization and histological evaluations showed CMC/PEO compositions reduced frequency and extent of epidural fibrosis compared to controls (no gel). Reduction of epidural fibrosis was accompanied by normal bone healing.

Evidence for effect on dural healing8

Indications

Two-level laminectomy and epidural fibrosis model (rabbit)

Method / Material

Two-level laminectomy performed at L4 and L5 in three groups of rabbits; FzioMed CMC/PEO gel group (n=35), Adcon-L group (n=28) and no gel control group (n=34).

Results / Conclusion

Gross and histological evaluations showed that application of CMC/PEO gel significantly reduced formation of epidural fibrosis but did not inhibit healing of dural incisions.

Evidence for reduction of radiculopathy in spinal surgery9

Indications

One-level microdiscectomy (270 patients)

Method / Material

Three groups of patients treated with MediShield Anti-adhesion Gel (n=90), Adcon-L gel (n=90) and no gel (n=90) and results compared at 6 weeks post-surgery.

Results / Conclusion

MediShield gel patient group had greater reduction in residual radiculopathy and need for physiotherapy compared to other groups. In recurrent cases, MediShield Anti-adhesion Gel reduced adhesion formation thereby shortening surgery time and reducing risk of damaging nerve root.

Last updated: 19 Aug 2016

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References

1 Blumenthal S, et al. Oxiplex reduces the incidence of back pain, leg pain and associated symptoms 6 months following single-level lower lumbar surgery for removal of herniated disc. Poster presentation, SpineWeek Geneva, Switzerland, 2008.

2 Arnold P, et al. Oxiplex gel reduces neurological sequelae following lumbar surgery. Poster 1147, American Association of Neurological Surgeons (AANS), Chicago, IL USA 2008.

3 Kim KD, et al. Multicenter clinical study evaluating Oxiplex in lumbar surgery. Presentation (abstract no. 73), Congress of Neurological Surgeons (CNS) 2008.

4 Wang JC and Arnold P. Oxiplex reduces the incidence of back pain, leg pain, and associated symptoms 6 months following single level lumbar laminectomy for removal of a herniated disc. Presentation, North American Spine Association (NASS) 2008.

5 Fransen P. Safety of carboxymethylcellulose/polyethylene oxide for the prevention of adhesions in lumbar disc herniation - consecutive case series review. Ann Sur Innov Res, 2:2, 2008.

6 Assietti R, et al. Use of carboxymethylcellulose/polyethylene oxide gel in microdiscectomy with interlaminectomy: A case series comparison with long-term follow-up. Spine, 33 (16): 1762-1765, 2008.

7 Rodgers, KE, et al. Reduction of epidural fibrosis in lumbar surgery with Oxiplex adhesion barriers of carboxymethylcellulose and polyethylene oxide. Spine J, 3:277-284, 2003.

8 Rodgers KE, et al. Evaluation of FzioMed adhesion barrier gel on dural healing in a model of epidural fibrosis in rabbits. Poster, Congress of Neurological Surgeons (CNS), Denver, CO USA, 2003.

9 Simons P, et al. Reduction of radiculopathy using MediShield Anti-adhesion gel in spinal surgery. Poster, Congress of Neurological Surgeons (CNS), San Fransisco, CA USA, 2004