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Technical information

What is SmartBone®/SwissBone® made of?

They are a composite material consisting of a bovine-derived mineral matrix reinforced with biopolymers and collagen fragments.

What is the biological mechanism of osteointegration of a bone graft?

Bone generally has the ability to regenerate completely, but it requires a very small fracture space or scaffold of some sort to do so. In fact, bone grafting is possible because bone tissue has the ability to regenerate completely when given the space to grow into, a bone graft. As the patient’s own bone grows, it usually completely replaces the graft material, creating a fully integrated region of new bone. The biological mechanisms that provide a rationale for bone grafting with composite grafts and xenografts are osteoconduction (controlling the reparative growth of natural bone) and osteoinduction (encouraging undifferentiated cells to become active osteoblasts). Only a few bone grafts guarantee complete remodeling; SmartBone®/SwissBone®, together with autografts, are among them.

What are the top mechanical performances of SmartBone®/SwissBone®?

Breaking stress of approx. 26MPa (av.) Elastic modulus of approx. 1.2GPa (av.) Breaking torque under screw connection (screw toughness) >55Ncm (av.)

Is SmartBone®/SwissBone® an open-pored material?

Yes! SmartBone®/SwissBone® have an open, interconnected, porous structure.

What is the microstructure of SmartBone®/SwissBone®?

The microstructure of SmartBone®/SwissBone® has been specifically designed to mimic natural, healthy human bone in terms of composition and porosity.

How long is the absorption of the biopolymers contained in SmartBone®/SwissBone® expected to take (on average)?

They are broken down and resorbed in about 4-6 months: In the meantime, they are broken down and resorbed, new born bone is formed.

Are SmartBone®/SwissBone® hydrophilic?

Yes! Due to their composition, SmartBone®/SwissBone® are extremely hydrophilic and can maintain an average swelling of 38% w/w in physiological fluids. This property allows the graft to rapidly and massively absorb blood once in situ, allowing for better and faster integration into the host tissue.

Which biopolymers are used?

We use biodegradable polymers that are also used in absorbable suture material

Where does the bovine-derived mineral matrix of SmartBone®/SwissBone® come from?

We supply our production with bovine tissue directly from fully certified companies in New Zealand, a “country with negligible BSE risk” (formerly known as a “BSE-free country”). We control our entire supply chain to the strictest standards and highest quality standards, including those of ISO 22442.

Can the biomaterial be mixed with a saline solution?

ABSOLUTELY NOT, the saline extracts the proteins from the polymeric reinforcement surface and compromises the performance of the graft and therefore the ultimate success!

Can the biomaterial be supplemented with autologous bone?

Clinical experience shows that in certain cases, e.g. large bone augmentations, the use of patient bone improves the integration process and is therefore recommended.

Can the biomaterial be supplemented with cadaver/donor bone?

The starting material has all the characteristics to achieve excellent integration and complete bone remodeling, inserting a cadaver bone unnecessarily increases the risk factors.

Can the biomaterial be supplemented with synthetic bone (bioglass, tricalcium phosphate, hydroxyapatite, polymers, collagen sponges, etc.)?

The starting material has all the properties to achieve excellent integration and complete bone remodeling on its own, the insertion of a synthetic bone unnecessarily increases the risk factors.

Can the biomaterial be placed in a syringe to increase perfusion and wettability?

The material has a very high wettability and hydrophilicity, it does not require any treatment. When using larger blocks, or when improved granule handling is desired, it is recommended to mix SmartBone®/SwissBone® with patient blood.

Do I have to use a membrane?

The use of the membrane is recommended, e.g. for horizontal augmentations, to protect the graft from dehiscence.

Can I reseal the vial/package after opening, sterilize it again, and within what time frame do I have to use it if necessary?

After opening the primary packaging (in a sterile surgical environment), the material must be used immediately on a single patient. The excess material must be disposed of in accordance with the IFU. SMARTBONE®/SWISSBONE® ARE INTENDED FOR SINGLE USE.

Why are SmartBone®/SwissBone® for single use?

SmartBone®/SwissBone® are supplied in their intact packaging as sterile medical devices and must be used immediately after opening. Storage after opening does NOT guarantee safety! SmartBone®/SwissBone® are therefore intended for single use.

Can I store the material in the refrigerator?

The material must be stored according to the instructions on the labels, i.e. away from sources of light or heat, in a dry place and between +2 and +25 °C.

The packaging arrived damaged. What am I to do?

DO NOT USE THE PRODUCT! Contact your dealer immediately.

There were no instructions and/or sticker in the box, what should I do?

DO NOT USE THE PRODUCT! Contact your dealer immediately.

At what time should the implant be inserted?

According to some studies, the healing time of a small defect is on average 4-5 months and the healing time of a larger defect is 7-8 months. In general, the right time to place the implant depends on the remaining bone volume at the site and also generally depends on the patient’s health, gender, age and graft site.

Mechanism of action

What mechanism of action does Swiss Bone have, since polymer may be degraded, but the Bonvine material certainly is not?

It is not entirely true that bovine bone does not resorb/remodel. It depends on the cleaning treatment you use.

Other bovine material does not resorb/remodel because they use a high temperature cleaning treatment. The hydroxyapatite is converted into a ceramic phase and there is no longer any possibility of remodelling.

Swissbone applies a low temperature cleaning treatment (acid attack) to remove all biological components but preserve the chemistry of the natural hydroxyapatite. Therefore, bovine bone can be remodeled by the human body. To protect the material from rapid resorption (in the first weeks after transplantation due to the body’s reaction), we apply a polymer layer. The polymer protects against rapid resorption and improves the mechanical properties.

There is also denatured collagen (pharmaceutical grade, as found in vaccines) in the microcoating associated with the polymer to promote cell adhesion (especially osteoclasts, which can destroy necrotic bovine bone).

If you look at the histologies after 2-3 years (it depends on the case, the patient, etc), there is no bovine bone detectable.

The bovine bone is therefore purely osteoconductive, the combination of Swissbone plus human body becomes an osteoinductive system.

When does osteoconduction occur during bone grafting?

Osteoconduction occurs when the bone graft material serves as a scaffold for new bone growth that is maintained by the native bone. Osteoblasts from the edge of the defect that is being grafted use the bone graft material as a scaffold on which they spread and form new bone. A bone graft material should be at least osteoconductive.

Are SmartBone®/SwissBone® osteoconductive?

YES! Histological analyses in in vivo and clinical studies have confirmed that SmartBone®/SwissBone® supports the ingrowth of stromal stem cells and osteoblasts, which then spread and settle to form new bone.

How is osteoinduction performed?

Osteoinduction involves stimulating osteoprogenitor cells to differentiate into osteoblasts, which then begin new bone formation.

Are SmartBone®/SwissBone® osteoinductive?

YES! SmartBone®/SwissBone® is a bone graft material that is both osteoconductive and osteoinductive: histological analyses performed during in vitro and in vivo, as well as clinical studies, confirmed that it not only serves as a scaffold for pre-existing osteoblasts, but also triggers the formation of new osteoblasts, theoretically promoting faster graft integration.

What are the dynamics of SmartBone®/SwissBone® osteointegration?

The cellular response to the SmartBone®/SwissBone® graft can be described as a progressive regeneration of healthy bone that occurs in parallel with the resorption of the graft: Both osteoconductive and osteoinductive processes are involved.

What is the time frame for complete osteointegration of SmartBone®/SwissBone®?

The integration of SmartBone®/SwissBone® grafts can be described as a progressive neo-formation of healthy bone that occurs in parallel with the reabsorption of the graft and involves both osteoconductive and osteoinductive processes within a time window of 16-18 months (depending on the volume grafted, the anatomical position, the age, the gender and the health status of the patient, etc.).

What type of bone is formed after transplantation with SmartBone®/SwissBone®?

The osteointegration of SmartBone®/SwissBone® leads to the formation of type II and type III bone.

What is the type of bone graft?

Bone grafts can be autologous (bone taken from the patient’s own body, often from the iliac crest), allogeneic (from cadaveric bone, usually obtained from a bone bank), or synthetic (often made from hydroxyapatite or other naturally occurring and biocompatible substances) with mechanical properties similar to bone.

What type of bone graft is SmartBone®/SwissBone®?

SmartBone®/SwissBone® is a composite bone graft consisting of a bovine mineral matrix reinforced with biopolymers and collagen fragments: it can therefore be categorized as a xeno-synthetic composite graft.

Dental surgery

Can the biomaterial be supplemented with PRGF?

Clinical experience shows that PRGF has no negative effects on the graft. It should be noted, however, that this type of protocol tends to favor soft tissue healing more than true bone regeneration.

Can the biomaterial be added with CGF?

Clinical experience shows that CGF has no negative effects on transplantation. It should be noted, however, that this type of protocol tends to promote soft tissue healing more than true bone regeneration.