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Each single unit of COVA™ is double packed and sterilized by irradiation.

Resorbable membrane for guided tissue regeneration and adhesion prevention

COVATM

DURA & SPINE

SPINAL SURGERY

Product safety:Biom’Up’s technology is based on a xenogenic acellular collagen. In addition, the Biom’Up collagen extraction process integrates validated steps for the inactivation of bacteria and viruses.

COVA™ has been designed, developed and patented (FR2944706), in compliance with European regulations (CE marking) and applicable international standards.

40 x 60 mm

60 x 80 mm

80 x 120 mm

Dimensions (mm) Re-order Code40 x 60 COV4660 x 80 COV6880 x 120 COV812

Manufactured by: Distributed by:

8, allée Irène Joliot Curie69800 Saint Priest - FranceTél. : +33 (0)4 86 57 36 10Fax : +33 (0)4 37 69 00 84 contact@biomup.comwww.biomup.com

LEGAL NOTICES:COVA™ & MATRI™BONE - Implantable Medical Devices for surgery. For use only by healthcare professionals, not refunded by Social Security. - NOT FOR SALES IN THE USA. Carefully read the instructions on the notice or labelling prior to use. CE 0086 : BSI. Manufacturer : biom’up SA France.

DESIGN: A retrospective study on the use of COVA™ membrane.

MATERIALS AND METHODS: 48 patients underwent lumbar spine surgery, all of whom had dural tube exploration, either by interlaminar access, hemi-laminectomy, or by total single or multi-level laminectomy.

COVA™ was routinely placed in contact with the dura mater at the end of the operation. Prior to implantation COVA™ was cut to the correct shape and size. The shaped piece was then applied and positioned but was not sutured in place. A Redon drain was placed just behind COVA™ for drainage.

RESULTS:

Between December 2009 and December 2010, 24 women (50%) and 24 men (50%) who had undergone lumbar spine surgery were followed up. The average age of the patients was 55.1 years (range 21 - 83 years). All 48 patients were followed at 6 months ± 2 months. No postoperative complications were reported during this follow-up period and no post operative infections nor discharge were observed. Of the 48 patients, 3 had repeat surgeries (6%) for reasons unrelated to the use of COVA™. It was noted during these reoperations that dissection of the dura mater was considerably easier.

CONCLUSION:

The use of COVA™ in 48 cases of lumbar spine surgery with an average retrospective follow up of 6 months showed that it is well tolerated and without risk. Of particular note there was no report of postoperative infection nor discharge. For the three repeat interventions carried out, dissection of the dura mater was made easier.

Laminectomy L3-L4 Membrane placed in contact with the dura mater.

Biom’up, with expertise in the field of biomaterials, has developed unique products based on collagen technology. These designed and clinically proven products cover many different surgical specialties - orthopaedics, spinal, dental, cardiac, general and maxillo-facial.

COVATM

DURA & SPINE

A DESIGNED BIOMATERIAL FOR THE PREVENTION OF ADHESIONSThe prevention of adhesions:

The presence of adhesions in the spinal region is a natural consequence of the healing phenomenon: peridural adhesions contribute to up to 24% of all failed spinal surgeries because of painful pulling or ischaemic compression of nerve endings potentially making subsequent repeat operations much more challenging 2. To prevent the formation of adhesions, Biom’Up has developed a patented technology: COVA™.

COVA™: Prevents the formation of post-operative adhesions by acting as a barrier between tissues during the healing process making reoperation safer and simpler.

* Tested by an independent laboratory

SEM image (Scanning Electron Microscopy): Surface of COVA™ showing how the collagen

Indications:COVA™ is indicated for the prevention of adhesions and for guided tissue regeneration after spinal surgery. The membrane pro-vides a cleavage plane between the dura mater and adjacent tissue and a major indication is if reoperation is likely. Other indica-tions are:• Discectomy• Posterior osteosynthesis• Radicular release• Recalibration• Laminectomy

• Safer & simpler reoperation 1,2

• Easy to place, resized and suture 4

• Biocompatibility• Optimised mechanical and elastic properties provide an appropriate handling of spinal surgeries• Resorbs over 13 weeks, matching the natural healing process and acts as an acellular barrier 3

• COVA™ can be resized 3

INSTRUCTIONS FOR USE: • Hydrate for 10-15 min before use 3

• After hydration, menbrane becomes white• Can be fixed (suture, glue...) in place 3

• Type-I acellular collagen membrane• Resorbable barrier*• Can be sutured

1 µm

Clinical results of efficacy and biocompatibility 2 :

References:1) Abstract COVA™ DURA&SPINE SOFCOT 2013 J-C. Le Huec, S. Aunoble, R. Saddiki, F. Sibilla, N.Pellet.2) Etude rétrospective portant sur l’utilisation de la membrane COVA™ SPINE. P. HENRY (Centre chirurgical Ambroise Paré, Neuilly-sur-Seine).3) COVA™ IFU.4) biom’up, internal data.

The avantages of COVATM :