Cova Ortho-Nerve

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COVA™ORTHO-NERVE COLLAGEN NERVE MEMBRANE

Cova™Ortho-Nerve is a resorbable collagen membrane used to guide healing by providing a cleavage plane between soft tissues and peripheral nerves.

Product Information

Cova™Ortho-Nerve provides superior peripheral nerve protection

Guided Tissue Healing

Cova™Ortho-Nerve is a pure collagen membrane designed for use as a barrier to allow guided healing along distinct anatomical planes. It is completely resorbable within a time frame that is compatible with healing.

INDICATIONS

Cova™ Ortho-Nerve provides a protective slip plane between damaged peripheral nerves and the tissue bed during healing. Cova™ Ortho-Nerve is indicated for the repair of peripheral nerve injuries in which there is no gap or where gap closure can be achieved by flexion of the extremity.

ADVANTAGES OF COVA™ORTHO-NERVE

- Type-I acellular collagen
- Semipermeable membrane (1)
- Resorbable over 13 weeks (1)
- Soft, pliable and conforms to anatomy
- Easy to trim, manipulate and suture (2,3)

References

(1) Data on file with Biom’Up.
(2) Prof. E. Masmejean et al. (Hôpital Européen Georges Pompidou – Paris) Publication in the e-report at the National Academy of Surgery, 2011 and SOFCOT, November 2010. Abstract accepted, ASSH, October 2010.
(3) Internal test: strength > 2N, reference E-CQ-026

ECONOMIC VALUE

Easy as 1,2,3.

  • 1

    Predictable Cost Structure

      All Cova Ortho-Nerve membranes cost the same - one price - all sizes
      Administrators can manage and predict procedural cost
      Surgeons can select the product that best meets the clinical need without concern for increasing procedural cost
  • 2

    Multiplied Economic Value

      One Cova Ortho-Nerve membrane can protect multiple nerves
      Select one wrap to protect multiple nerves on the same procedure
      Reduce cost by over 50% when two or more nerves are protected with one wrap
  • 3

    Simplified Product Selection

      Select the wrap that matches the nerve length to be protected
      Each wrap can cover a range of nerve diameters based on anatomical data and membrane size (1)
      Reduce inventory overhead and material management cost

References

(1) > S Standring, Gray’s Anatomy, 41st Edition, (Elsevier Sep., 2015). Sizing chart is only a suggestion based on anatomical data and based on the size of the membrane. Final choice is left to the surgeon. The membrane can be resized to adapt to the defect.

Clinical Results & Abstracts

Clinical results of an efficacy and bio-compatibility study (1)

Design: Prospective clinical study

Patients: 12 patients (average age 51.5 years) presented with significant nerve disability pre-operatively and underwent neurolysis
Procedure: Neurolysis followed by implantation of Cova™ Ortho-Nerve membrane around the released peripheral nerve tissue.
Results: After a minimum follow-up of 6 months, irritation had significantly decreased and/or mobility improved partially or completely. No allergic reaction was noted.

Median nerve neurolysis repair (1)

History: Irritation of the median nerve due to a suture at the wrist after thumb opposition transfer following a complex wrist wound (median nerve suture).
Procedure: Neurolysis of the median nerve suture and tenosynovectomy of the flexors; protection of the nerve with Cova Ortho-Nerve membrane (30 x 40 mm).
Results after 1 month follow-up: Complete disappearance of the irritation syndrome. Excellent thumb mobility post-operation.

Median nerve neurolysis graft (1)

History: Secondary nerve graft following a complex wrist wound; satisfactory nerve recovery with a major median nerve irritation of the wrist.
Procedure: Neurolysis graft combined with tenosynovectomy of the flexors; protection of
the graft with Cova™Ortho-Nerve membrane (30 x 40 mm).
Very positive results at 3 month follow-up with almost complete disappearance of the irritation.

References

(1) Prof. E. Masmejean et al. (Hôpital Européen Georges Pompidou – Paris) Publication in the e-report at the National Academy of Surgery, 2011 and SOFCOT, November 2010. Abstract accepted, ASSH, October 2010.

Evaluation of a new anti-adhesion collagen resorbable membrane (Cova™ ORTHO) following nervous upper limb surgery. Tordjman D, Schlur C, Mamane W, Masmejean E, Annual Congress of French Hand Surgery Society / de la Main. 2012. 31 (6), 416

Purpose: The aim of this study is to analyze the efficacy and tolerance of a new anti-adhesion resorbable collagen membrane CovaTM Ortho for primary and secondary upper extremity nerve surgery.

Methods: Retrospective study including 40 patients, with an indication of neurolysis at upper extremity with a partial sensory and motor deficit and/or a disabling irritative syndrome, included in a 29-months period (04/2009-09/2011). The series involves 25 males and 15 females. The mean age is 48.3 years-old (15-83).
Primary neurolysis concerned elbow ulnar nerve neurolysis with anterior subcutaneous transposal for 11 patients (27.5%). Secondary neurolysis involved 29 patients (72.5%) including recurrent or recalcitrant carpal tunnel syndrome (n=7), recurrent cubital tunnel syndrome at the elbow (n=3), post-trauma neurolysis (n=12), or after nerve graft (n=3) neuroma (n=2), thoracic outlet syndrome (n=1) and median nerve compression by tendon transfer (n=1).

Primary Endpoints: Quick Dash score, pain (EVA), grip strength measured by Jamar® dynamometer, sensitivity, motricity, paresthesias, irritative syndrome and patient’s satisfaction.

Key Findings: The Quick Dash test (performed in 80% of the cases) improved 14 points (+5/-11).
Jamar® dynamometer grip strength (assessed in 72.5% of the cases) improved of 8% (-28%/+45.4%).
Pain was completely resolved in 25% of the cases and improved in 55% of the cases. Sensitivity, a S4 complete recovery was observed in 23% of the cases and an improvement in 40% of the patients. Motricity, a M5 complete recovery was noted in 20% of the cases and an improvement in 20% of the cases. Complete resolution of paresthesias was observed in 30% of the cases and an improvement in 45% of the cases. Irritative syndrome, a complete resolution was observed in 53% of the cases and an improvement in 35% of the cases. Patients’ global satisfaction was considered excellent or good in 75% of the cases, moderate for 10% and weak in 15% of the cases.

Conclusion: The collagen membrane is a natural and resorbable device presenting with excellent patient tolerance. The procedure for using this anti-adhesion collagen membrane is simple, reliable and reproducible

Reduction of neural scarring after peripheral nerve suture: an experimental study about collagen membrane and autologous vein wrapping. L. Mathieu, C. Adam, J. Legagneux, P. Bruneval, E. Masmejean. Chirurgie de la Main. 2012; 31:311-7.

Purpose: The effects of a collagen membrane(CovaTM Ortho) and a technique of autologous vein wrapping on scar formation after peripheral nerve suture are investigated.

Methods: Forty-eight sciatic nerves from Wistar rats were transected and repaired, then allocated to a control group C (n = 16) and two experimental groups: in group A (n = 16) the repair line was covered by the collagen membrane, and in group B (n = 16) the repair line was wrapped by an external jugular venous graft

Primary Endpoints: Macroscopic evaluation and histologic evaluation of extraneural and intraneural fibrosis.

Key Findings: Three months later, it was observed that adhesions in the surrounding tissues were significantly less in groups A(collagen membrane) and B(vein wrap) compared to group C (control), and significantly less in group A than in the group B. In group A, the sciatic nerve could be detached from the surrounding muscle tissue, or was wrapped in a thin fibrous, translucent, and easily cleavable tissue. After 3 months, the collagen membrane was completely resorbed in all cases. Histological analysis revealed no significant reduction of extraneural or intraneural scar tissue in groups A or B compared to group C. However intraneural fibrosis was significantly less in the group A than in the group B.

Conclusion: It was concluded that the collagen membrane was effective in reducing neural scar formation after peripheral nerve suture. Autologous vein wrapping also showed a favorable effect in this indication despite less successful histological outcomes.

Comparison of a collagen membrane versus a fibrin sealant after a peroneal nerve section and repair: a functional and histological study. V. Pertici, J. Laurin, T. Marqueste, P. Decherchi. Acta Neurochir (Wien). 2014; 156(8): 1577-90

Purpose: To date, fibrin sealant is considered to be one of the most effective substitutes to prevent post-operative fibrosis and to limit neuroma formation after nerve suture. Because fibrin sealant presents a number of drawbacks, more suitable techniques should be considered. The aim of this study was to functionally and histologically compare the efficiency of a fibrin sealant to a resorbable semi-permeable porcine type I collagen membrane(CovaTMOrtho) after a peroneal nerve lesion and repair on rats.

Methods: Rats were divided into four groups: (1) a SHAM group (n=10) in which surgery was performed without damaging the nerve, (2) a LESION group (n=15) in which the nerve was cut and immediately sutured without additional treatment, (3) a MEMBRANE group (n=30) in which a collagen membrane was wrapped around the lesion site, and (4) a GLUE group (n=30) in which the peroneal nerve was coated by fibrin sealant. Peroneal Functional Index (PFI), kinematic analysis of locomotion, muscular atrophy, axonal regrowth, and irritant ranking score (IRS) were performed during three months post-surgery.

Primary Endpoints: The peroneal functional index, kinematic analysis of movement, muscle weight measurements and histology; inflammatory reactions, histopathological analysis, axonal regrowth.

Key Findings: Our results indicate that at the third month post-surgery, no difference in both the functional recovery and the histological measurement was observed between groups. However, no deleterious effect was observed following the use of the collagen membrane. Indeed, the porcine membrane was well-integrated into the host tissue, with no noticeable foreign body reaction at three months post-surgery.

Conclusion: Our preliminary results highlight the fact that the collagen membrane could be used as an alternative to fibrin sealant in peripheral nerve repair surgery. Indeed, animals in which the collagen membrane was used to wrap the lesion site exhibited similar functional and histological results as animals in which a fibrin sealant was used to coat the lesion. The greatest advantage of this membrane is that it could be used as a drug delivery device, regulated by its degradation rate.

Cova™ Ortho-Nerve Surgical Videos

Intra-operative videos demonstrating Cova™ Ortho-Nerve

Cova Ortho-Nerve Procedures

Clinical Application Examples

  • Neurolysis
  • Neuroma-in-continuity repair
  • Nerve graft protection
  • End-to-end nerve repair
  • Secondary neurolysis
  • Revision median neurolysis
  • Revision ulnar neurolysis

Cova Ortho-Nerve IFU

Instructions for use

Cova Ortho-Nerve 510 (K)

FDA Clearance for Cova Ortho-Nerve

  • 510K

COVA™ ORTHO-NERVE

Brochures Description

22901 Millcreek Blvd. Suite 360
Cleveland, Ohio 44122
United States
216-378-9107
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