novosorb btm -...

Improving outcomes. Changing lives.

NovoSorb® BTMA unique synthetic biodegradable wound matrix

Regain control.Graft when you want to, not when you are forced to.As a surgeon, you should be in control. NovoSorb BTM offers a fully temporizing solution, allowing surgeons to graft when the patient is ready; in stages or all at once.

BTM is a synthetic, biodegradable and biocompatible device designed to facilitate the dermis to grow within a patented polyurethane foam matrix. When ready, the sealing membrane is removed, leaving a fully vascularized dermis, ready for closure.

BTM Advantages• Fully synthetic, completely biodegradable and

biocompatible, with no biologic material.

• No preparation, ready to use.

• Physiologically seals the wound – so healing can begin.

• Clinically choose when to delaminate.

• Designed to minimize scarring and contracture.

Composition

NovoSorb BTM Wound Dressing is composed of three layers.

Sealing membraneDesigned to physiologically close the wound and limit evaporative moisture loss.

Bonding layerPolyurethane adhesive bonds foam to the sealing membrane.

Polyurethane foam2mm open cell biocompatible foam with >90% porosity designed to fully biodegrade.

Bonding layer

Foam

Sealing membrane

Phases of BTM integration

2BTM integrates into the wound bed• Blanch test to determine full vascular integration and

rapid reprofusion.

1Apply BTM to a full thickness wound• Fully clean and debride wound removing all necrotic,

non-viable tissue.

• Abut BTM to wound margin and contour to fit anatomy.

Removal of sealing membrane• Remove sutures/staples followed by delamination

in one smooth motion.

• Removal may be done in phases.

Wound closure• Method of closure is surgeon’s clinical choice.

3

4

BTM applied to right forearm

“I’m very happy with the outcome and have full movement of my arm.”

NovoSorb® BTM biodegradable temporizing matrix

A synthetic biomaterial designed to provide:• Mechanical support for cellular activity.

• Rapid cell ingrowth due to the high porosity.

• Degradation through hydrolysis.

Applied BTM Early integration

Ready to delaminate Neo-dermis

BTM vs non-BTM areas on the same patient

The following cases highlight areas for each patient where BTM was applied as well as areas that did not receive BTM.

Day 368 BTM

Patient 1: BTM applied to highly mobile area around the arm

No BTM

Note the hypertrophic scarring and contracture.

Day 536 BTM

Patient 3: Supple skin on BTM back vs the chest scarring

No BTM

Supple skin on the back where BTM was applied, as opposed to considerable scarring on the chest.

Patient 2: Notice the return of pigmentation to the BTM arm vs the keloid scarring on the chest

Day 312 BTM No BTM

BTM applications

Necrotizing fasciitis of the neckResults at Day 77 showing full range of movement and lack of contraction. Notice the natural contouring under the chin.

Free flap donor site applicationCurrent standard of care non-BTMNote the scarring and the tendons in this example of the traditional approach.

BTM - An innovative solutionNote the lack of scar/contracture and topography.

Day 0open

Day 180No BTM

Day 77

“NovoSorb BTM has changed the lives of patients at our hospital.”Professor John Greenwood Royal Adelaide Hospital

Staged grafting

BTM allows staged grafting in cases with insufficient donor site skin.Note half the back was grafted at day 31 while BTM remained in place on the other half until more donor graft could be harvested at day 38.

BTM applied over entire back, notice early signs of integration. Half the back was delaminated and mesh grafted. BTM left in place on other half of back.

Day 31

Day 3

Notice rapid rate of closure of the interstices after 7 days. Remaining half of back is delaminated and prepared for grafting.

Day 38 post BTM

Day 88

Patient outcomes

Necrotizing fasciitisFull range of motion restored to complex area around neck and chest after BTM application. Note the contouring around the complex area of the Adam’s apple.

Day 115

Trauma casesOver tendonBTM applied over exposed tendon. Range of motion restored after trauma to dorsal foot.

Over boneBTM applied over the calvarium. Helped facilitate the growth of neo-dermis preparatory to skin grafting.

Changing lives

Day 316

Day 115

Biodegradable and biocompatible

Designed to facilitate growth, then safely disappearNovoSorb BTM has been designed for tissue integration with your patient’s safety and cellular health in mind by removing aromatic isocyanates and solvents.1

The NovoSorb foam degrades through hydrolysis by established pathways2 forming hydroxy-acids such as L-lactic acid, and is gone by 18 months.3

Histology – BTM resorbed in 18 months

6 months 9 months

12 months 18 months

Please see our Instructions For Use for contraindications, warnings and precautions. These can be found on our website at: polynovo.com/products/btm/

Application Site BTM size Surface area ~No: Sheets

Neck 10x20cm 200cm2 1–2

Anterior Trunk 20x40cm 800cm2 3–4

Posterior Trunk 20x40cm 800cm2 3–4

Buttocks 20x40cm 800cm2 2

Arms 10x20cm 20x40cm

200cm2 800cm2

A mix of sizes is advised to tailor to contours

Legs 10x20cm 20x40cm

200cm2 800cm2

A mix of sizes is advised to tailor to contours

Melanoma/wide excisions 10x10cm 100cm2 1–2

10x20cm 200cm2 1

DRFU 10x10 cm 100cm2 1

VLU 10x10 cm 100cm2 1

Estimate of pieces required

BTM comes sterilized in a multilayer packaging. A cardboard envelope contains a white aluminized peel-able pouch which encloses a sterile transparent peel-able pouch containing the BTM. Labels are affixed to the white aluminized pouch and the outer cardboard envelope, and carry details such as date of manufacture, product batch number and expiration date. Each pouch is nitrogen filled. Sterilization: Gamma irradiation.

Code Description Sold as

BTM-1010 (PS-004) NovoSorb BTM Wound Dressing (10cm x 10cm) Each



References

1. Zdrahala RJ, Zdrahala IJ. Biomedical applications of polyurethanes: a review of past promises, present realities, and a vibrant future. J Biomater Appl. 1999 Jul;14(1):67-90.

2. Tatai et al. Thermoplastic biodegradable polyurethanes: the effect of chain extender structure on properties and in-vitro degradation. Biomaterials. 2007 Dec;28(36):5407-17. Epub 2007 Oct 3.

3. Wagstaff et al. A Biodegradable Polyurethane Dermal Matrix in Reconstruction of Free Flap Donor Sites: A Pilot. http://eplasty.com/index.php?option=com_content&view=article&id=1370&catid=188:volume-15-eplasty-2015.

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PolyNovo North America LLC4023 Kennett Pike, Suite 55169Wilmington, DE 19807

T 302.268.6163F 800 517 1975

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