ADVANCED BONE GRAFT - inspine.be

S Y S T E M O V E R V I E W

A DVA N C E D B O N E G R A F T

NANOSS BIOACTIVE | ADVANCED BONE GRAFT

NANOSS BIOACTIVE

nanOss Bioactive ........................................................................................................................................................................................

Nano-structured Crystals & Engineered Carrier ...........................................................................................................................................

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Table Of Contents

INTRODUCTION

ORDERING INFORMATION

System Overview ........................................................................................................................................................................................

NANOSS BIOACTIVE COMPONENTS

1

nanOss Bioactive Clinical Application ..........................................................................................................................................................

nanOss Bioactive Spinal Fusion Study .........................................................................................................................................................

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3

CLINICAL

nanOss Bioactive Indications, Contraindications, Warnings, Precautions ...................................................................................................... 4

INDICATIONS & WARNINGS

SYSTEM OVERVIEW

ADVANCED BONE GRAFT

SYST

EM O

VERV

IEW

nanOss Bioactive is an advanced bone graft combining an engineered extracellular

matrix bioscaffold proven as an ideal pathway for cell infiltration & osteoconductive

nano-structured crystals that mimic the composition, structure, & size of bone1,

providing a natural bone growth solution.

NANOSS BIOACTIVE IS SYNTHETIC HUMAN BONE

• nanOss Bioactive’s osteoconductive scaffold is composed of nano-structured

crystals that are the:

n Same size as human crystals.

n Same composition as human crystals.

n Same shape as human crystals1.

NANOSS BIOACTIVE SYSTEM OVERVIEW

Material Crystal Size

Human Bone 25-500 nm

nanOss Bioactive 15-100 nm

Traditional Calcium Phosphate 1,000-10,000 nm

Human bone mineral. Nano-structured crystals.

Nano-structured crystals are the same shape & size as human bone.

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NANOSS BIOACTIVE


COMPONENTS

• Nano-structured crystals have extremely high surface area for cell attachment.

• High surface area provides more cell attachment sites for osteoclasts & osteoblasts resulting in dramatically improved mineralisation, remodeling & bone formation.

• Solid bone formation results from attachment of osteoblasts to the surface of the nano-structured crystals & integration of the crystals into newly formed bone.

• nanOss Bioactive fully incorporates into the patient’s own newly formed bone resulting in a fusion mass which is the ultimate goal of any bone graft.

NANO-STRUCTURED CRYSTALS

Osteoblasts attached to nano-structured crystals.

• The engineered carrier provides the physical structure for cell infiltration & cell attachment, as well as an ideal environment for bone formation.

• Synthesised of a highly purified derivative of porcine collagen.

• Patented manufacturing process unwinds collagen producing an open scaffold.

• Open Scaffold.› Provides an ideal pathway for cell infiltration & attachment to begin bone repair.

› Provides the healing environment necessary for bone formation.

› Supports bone repair, allowing the body to help heal itself.

NANOSS BIOACTIVE'S ENGINEERED CARRIER IS DESIGNED FOR CELLS

Open structure of engineered carrier.

Human Bone nanOss BioactiveCompetitive Synthetic

Products

100 m2/g 70 m2/g Less than 1 m2/g

Surface Area

2

SYSTEM OVERVIEW

3ADVANCED BONE GRAFT

CLIN

ICAL

NANOSS BIOACTIVE CLINICAL APPLICATION

nanOss BioactiveCompetitve

Silicate Product Autograft

PEAK

LOA

D ( N

)

*nanOss Bioactive resulted in a significantly higher peak load compared to the Competitive Product, (p<0.05), but was not different than Autograft. There was no significant difference between the Competitive Product and Autograft.

Autograft Bone

nanOss Bioactive Granule

Bone Marrow

New Bone

NANOSS BIOACTIVE SPINAL FUSION STUDY3

• L5-L6 Posterolateral Fusion in rabbits.

• 12 Week Duration.

• 3 Treatment Groups.› nanOss Bioactive + Bone Marrow Aspirate + Autograft

› Competitive Product + Bone Marrow Aspirate + Autograft

› Bone Marrow Aspirate + Autograft

• RESULTS - nanOss Bioactive mixed with bone marrow aspirate and Autograft had:

› Excellent handling properties.› 2.5 times more new bone formation than Competitive Product.

› Statistically stronger fusions (peak load and stiffness) than the Competitive Product.

› Excellent histology results.

• Posterolateral fusion.› Patient treated with nanOss Bioactive combined with bone marrow aspirate.

› 1 year CT image2.

4 NANOSS BIOACTIVE


Unit Size Product Catalog # Storage

2cc nanOss Bioactive 90-100-02E Room Temperature



NANOSS BIOACTIVEORDERING INFORMATION

Use of nanOss Bioactive is contraindicated in the presence of one or more of the following clinical situations:

• fractures of the epiphyseal plate.

• metabolic or systemic bone disorders that affect bone or wound healing.

• fractures for which stabilisation of the fracture is not possible.

• significant vascular impairment proximal to the graft site.

• infected or contaminated wounds, or fractures for which intraoperative soft tissue coverage is not planned or possible.

• acute and chronic infections in the surgical area (soft tissue infections; inflammatory, bacterial bone disorders, osteomyelitis).

• impaired calcium metabolism.

• treatment with steroids and other drugs affecting calcium metabolism.

• immunosuppressant therapy.

• use in the area of the open epiphyseal growth plate.

• patients allergic to porcine collagen products.

CONTRAINDICATIONS

INDICATIONS

nanOss Bioactive is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is

indicated to be gently packed into bony voids or gaps in the spine in conjunction with bone marrow aspirate or bone marrow

aspirate and autograft bone. These defects may be surgically created osseous defects or defects created from traumatic injury

to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing

process.

NANOSS BIOACTIVE - INDICATIONS & WARNINGS

SYSTEM OVERVIEW

5ADVANCED BONE GRAFT

NANO

SS B

IOAC

TIVE

- IN

DICA

TION

S &

WAR

NING

S

nanOss Bioactive does not possess sufficient mechanical strength to support the reduction of a fracture site prior to soft and

hard tissue in-growth or to support a load. Standard internal fixation techniques such as the use of plates and/or screws must

be followed to obtain rigid stabilisation. External stabilisation alone is not sufficient to achieve the rigidity necessary for bony

in-growth of the nanOss Bioactive material. nanOss Bioactive must not be used to gain screw purchase or to stabilise screw

placement. Screws used with nanOss Bioactive and fixation devices must attain rigid fixation into the host bone.

Complete postoperative wound closure is essential. nanOss Bioactive must not be used to repair metaphyseal defects where

complete soft tissue coverage cannot be achieved. nanOss Bioactive must not be used to gain screw purchase or to stabilise

screw placement. All screws used in conjunction with this product and fixation devices must attain rigid fixation into the host

bone. Avoid application of the nanOss Bioactive beyond intended treatment site, as this may damage surrounding tissues.

This system has not been evaluated for safety and compatibility in the MR environment. This system has not been tested for

heating or migration in the MR environment.

WARNINGS

PRECAUTIONS

nanOss Bioactive is intended for use only by surgeons familiar with bone grafting and rigid fixation techniques. Standard

postoperative practices should be followed, particularly as applicable to defect repairs involving the use of fixation devices.

nanOss Bioactive granules are radiopaque and the radiopacity may mask underlying pathological conditions. nanOss Bioactive

is intended for single use only.

• do not apply nanOss Bioactive dry to the defect.

• do not resterilise nanOss Bioactive.

• discard any un-used nanOss Bioactive.

• nanOss Bioactive has no weight bearing function.

• postoperative patient management should follow the same regimen as similar cases utilising autogenous bone grafting.

Standard postoperative practices should be followed, particularly as applicable to defect repairs involving the use of fixation

devices.

• always follow recommended mixing instructions when rehydrating nanOss Bioactive.

Human clinical data is limited at this time.

REFERENCES:

1. Ahn, E. & Webster, T. Enhanced Osteoblast & Osteoclast Function on nanOss a Calcium Phosphate Nanotechnology. Pioneer Internal Document.

2. Lumbar Spinal Fusion Results Using nanOss Bioactive: One Year Follow-Up. Pioneer Internal Document. December 2010.

3. Walsh, W, Hill, R.S., Lloyd, W., Bertollo, N., Shinoda, T., Merger, A., Oliver, R., & Yu, Y. In vivo Response to Synthetic Bone Graft Substitutes in a Preclinical

Posterolateral Fusion Model. Presented at the 2009 North American Spine Society Meeting, San Francisco, CA, Nov 2009.

*See product insert for complete labeling limitations related to this device.

MKT-297-A/113267

© 2012 Pioneer Surgical Technology. All rights reserved. The trade name Pioneer Surgical as used herein and elsewhere refers to the legal entity Pioneer Surgical Technology, Inc. The following trademarks are registered in the U.S. and owned by Pioneer Surgical: Pioneer, Moving Forward Together and nanOss.

Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855

800-557-9909www.pioneersurgical.com

Pioneer Surgical Technology BVVoorveste 7, 3992 DC HoutenThe NetherlandsTel. +31 30 693 47 20 / Fax. +31 30 693 47 [email protected]

CoC Utrecht 30214021

Authorized EC Representative:RSQR Ltd.Room 402 Ludgate House107-111 Fleet StreetLondon EC4A 2AB, [email protected]

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ADVANCED BONE GRAFT - inspine.be