FAQ

FAQ

IBI SA

IBI is a Swiss company, headquartered in Canton Ticino, in the south-eastern corner of Switzerland.

All IBI production is Swiss made, a guarantee of extreme excellence in terms of both quality and safety.

IBI is ISO13485:2016 certified.

Technical information

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

Bone generally has the ability to regenerate completely, but it requires a very small fracture space or some sort of scaffold to do so. Indeed, bone grafting is possible because bone tissue has the ability to regenerate completely if provided the space into which to grow, a bone graft. As native bone grows, it will generally replace the graft material completely, resulting in a fully integrated region of new bone. The biologic mechanisms that provide a rationale for bone grafting with composite grafts and xenografts are osteoconduction (guiding the reparative growth of the natural bone) and osteoinduction (encouraging undifferentiated cells to become active osteoblasts). Only few bone grafts ensure a complete remodeling, SmartBone®/SwissBone®are among these, together with autografts.

Breaking Stress of about 26MPa (av.) Elastic Modulus of about 1,2GPa (av.) Breaking torque under screw fixation (screw tenacity) >55Ncm (av.)

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

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

They are degraded and resorbed in about 4-6 months: meanwhile they degrade and get resorbed, new born bone is formed.

Yes! Due to their composition SmartBone®/SwissBone® are extremely hydrophilic and can sustain a 38% w/w (av.) swelling in physiologic fluids. This feature allows the graft to quickly and massively absorb blood once in situ, hence sparkling a better and faster integration with the host tissue.

We use biodegradable polymers, the same used in resorbable sutures.

We supply our production with bovine derived tissues directly from fully certified companies in New Zealand, a “BSE negligible risk Country” (formerly known as “BSE free Country”). We control all our supply chain, according to the most strict norms and highest quality standards, including those of ISO 22442.

IBI applies a proprietary process to produce SmartBone®/SwissBone®.

ABSOLUTELY NOT, the saline solution extracts the proteins from the polymeric reinforcement surface, compromising performances of the graft and thus the final success!

Clinical experience shows that in particular cases, such as large bone augmentations, the use of patient bone improves the integration process, and it is hence recommended.

The starting material has all the characteristics to achieve an excellent integration and a complete bone remodeling, the insertion of a cadaveric bone unnecessarily increases risk factors.

The starting material has all the characteristics to achieve by itself an excellent integration and a complete bone remodeling, the insertion of a synthetic bone unnecessarily increases risk factors.

The material has a very high wettability and hydrophilicity, does not require any kind of treatment. In case of use of larger blocks, or when looking for improved granulates handling, it is recommended to mix SmartBone®/SwissBone® with patient’s blood.

The use of the membrane is recommended, e.g. in cases of horizontal augmentations, in order to protect the graft from any dehiscence.

Once the primary packaging has been opened (in sterile surgerical environment), the material must be used immediately on a single patient. The surplus material must be disposed of according to IFU. SMARTBONE®/SWISSBONE® ARE SINGLE USE.

SmartBone®/SwissBone® are provided, in its intact packaging, as a sterile medical device; once opened, it must be used immediately. Storage after opening does NOT ensure safety! SmartBone®/SwissBone® are, hence, single use.

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

DO NOT USE THE PRODUCT! Contact your dealer immediately.

DO NOT USE THE PRODUCT! Contact your dealer immediately.

According to some studies, the healing time of small defect is averagely 4 – 5 months and the healing time of bigger defect is 7-8 months. In general, the correct timing for insertion of the implant depends on the residual bone volume in the site and also it generally depends on patient’s health condition, sex, age and grafting site.

Mechanism of action

Osteoconduction occurs when the bone graft material serves as a scaffold for new bone growth that is perpetuated by the native bone. Osteoblasts from the margin of the defect, that is being grafted, utilize the bone graft material as a framework upon which to spread and generate new bone. In the very least, a bone graft material should be osteoconductive.

YES! Histological analyses performed during in vivo and clinical studies confirmed that SmartBone®/SwissBone® support the ingrowth of stromal stem cells and osteoblasts, which then spread and colonize it, hence generating new bone.

Osteoinduction involves the stimulation of osteoprogenitor cells to differentiate into osteoblasts that then begin new bone formation.

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

The cellular response to SmartBone®/SwissBone® graft can be described as a progressive neoformation of healthy bone, which occurs alongside the resorption of the graft: both osteoconductive and osteoinductive processes are involved.

SmartBone®/SwissBone® graft integration can be described as a progressive neoformation of healthy bone, which occurs alongside the reabsorbtion of the graft, involving both osteoconductive and osteoinductive processes on a 16-18 months time window (depending on grafted volume, anatomical position, patient age, sex, health conditions, etc).

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

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

SmartBone®/SwissBone® are a composite bone graft made of a bovine derived mineral matrix, reinforced with biopolymers and collagen fragments: it can hence be categorized as a composite xeno-synthetic graft.

Dental Surgery

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

Clinical experience shows that CGF has no negative effects on grafting. However, it should be noted that this type of protocol tends to favour soft tissue healing more than true bone regeneration.

Orthopaedic surgery

Clinical experience shows that biomaterials should NOT be mixed together, as this can lead to incomplete regeneration or even grafting failure. SmartBone® can only be mixed with autologous bone (i.e. bone from the patient himself).

SmartBone® Ortho shall be always put in close and tight contact with living bone tissue. In case a portion of the graft goes in contact with non-bony tissues (e.g. connective tissues, etc), a long-lasting collagen-based membrane or a surgical membrane shall be used to separate the bone graft from non-bony tissues. This favours bone regeneration, while impedes improper cellular colonization of the graft.

Contacts

IBI S.A.
Industrie Biomediche Insubri S.A.
via Cantonale 67, CH-6805 Mezzovico-Vira, Switzerland
t. +41 91 93.06.640
f. +41 91 220.70.00