Moldable bone substituteEngineered for orthopaedic surgery

SINTlife Paste, Putty and Granules are synthetic fully resorbable grafts made of magnesium substituted hydroxyapatite nano-crystals.

Mimicking nature, magnesium ions are introduced into apatite crystal cells replicating the same positioning and composition as found in the mineral phase of human bone, making this the obvious formula for bone regeneration.

The winning formula

SINTlife is a unique material that interacts with bone-forming cells and promotes deposition of new bone tissue.Thanks to its specific biomimetic chemical composition, nano-structure and surface properties, SINTlife is remodelled and resorbed by cellular action over a period of 6-18 months, allowing for sufficient biostimulative scaffold to remain during the formation and maturation of new bone. During the remodelling phase, osteoclastic resorption and osteoblastic osteogenenetic activities are seen around the remaining SINTlife particles*, up to a complete bone regeneration. As a result, SINTlife leads to a physiological, rapid and effective repair.

*Landi et al., J. Mater Sci: Mater Med (2008)

Synchronized process: material resorption and new bone formation

Evidence of SINTlife osteointegration in human at 45 days post-op (40x, tricromic) Courtesy of Prof. Trombelli

Human osteoclasts remodeling SINTlife particles at 45 days post-op (40x, CD68+ antibody) Courtesy of Prof. Trombelli

Osteointegrated SINTlife particles in human showing continuity with the newly-formed bone at 5 months post-op (polarized light) Courtesy of Dr. Crespi

Bone cells

Proteins

H2O

Mg

Mg

Mg

SINTlife

SINTlife paste

1 micron

It has been demonstrated that the presence of Mg2+ enables the hydroxyapatite crystal cell structure to become unstable and biologically active, promoting rapid cell-mediated material resorption, bone formation and remodelling.

In addition, Mg2+ substituted apatite displays improved surface properties: the biomaterial effectively interacts with water molecules* to rapidly capture the key proteins involved in osteogenesis.

*Bertinetti et al. Langmuir (2009)

Mg-substituted apatite: just as nature designed it

50 nm

Nanostructure (SEM image) Mg-HA nanoparticles (TEM micrograph)

Interaction between Mg-HA, water molecules, proteins and bone cells

××

×

××

×

×

o

o o

o

× = SINTlife o= New Bone

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o

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EnginEErEd with thE highEst biomimEtic nanotEchnologiEs

Physiologically rElEvant cEll-mEdiatEd rEsorPtion

Fully rEsorbEd and rEPlacEd by bonE

mallEablE, moldablE, oFF-thE-shElF

Clinical applications

Tarsal fracture Femoral cysts Posterolateral fusion Lumbar ALIF

SINTlife is designed for use in a broad range of procedures, such as:

· Traumatology

_ Upper and lower extremities

· Bone cavity filling

_ Cysts

· Spinal surgery

_ Cage fillings

_ Posterolateral fusions

SINTlife is not intended to modify or replace standard procedures for the treatment of bone defects, but for filling bony voids or gaps of the skeletal system, that are not intrinsic to the stability of the bony structure.It must be used with appropriate stabilising hardware.

SINTlife may be combined with autologous bone, blood, bone marrow or growth factors.

· Paste Code desCription Quantity per paCkage

PFS015055-56-00 Nanostructured Paste (syringe 1cc) 1 cc

PFS015055-59-00 Nanostructured Paste (syringe 2,5cc) 2,5 cc

PFS015055-57-00 Nanostructured Paste (syringe 5cc) 5 cc

PFS015056-01-00 Nanostructured Putty (syringe 1cc) 1 cc

PFS015056-02-00 Nanostructured Putty (syringe 2,5cc) 2,5 cc

PFS015056-00-00 Nanostructured Putty (syringe 5cc) 5 cc

PFS015056-03-00 Nanostructured Putty (2 syringes x 5cc) 2 x 5 cc

PFS015055-26-00 Microgranules (size 600-900 µm) 5 cc

PFS015055-13-00 Microgranules (size 600-900 µm) 15 cc

MP

A00

0650

-23-

00

· Putty

· Granules

Fin-Ceramica Faenza S.p.A. A Tampieri Financial Group S.p.A. Company

Production facilities: Via Ravegnana, 186 - 48018, Faenza (RA) - IT

Legal office: Via Granarolo, 177 /3 - 48018, Faenza (RA) - ITPh. +39 0546 607311 - Fax +39 0546 607312info@finceramica.it

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www.finceramica.it

Shapes and Sizes