Resorbable Calcium Phosphate Cement
Bone Graft Substitute Uniquely Formulated for Superior Strength and Resorption
Our proprietary calcium phosphate (CaP) cement formulation, Trabexus is the solid foundation on which we built our expertise. Combining osteoconductivity, biocompatibility and incredible strength we designed Trabexus.
With the surgeon, the patient, and the payer in mind, our original bone void filler quickly repairs damage and becomes a discreet, harmonious part of the subsequent restorative process.
With our signature CaP, surgeons no longer need to choose between strength and resorption. Instead, patients will be assured their best chance for a quick, safe, and complete recovery. Total time from mixing to wound closure is 4.5–15 minutes.
Instructions for Use:
Trabexus is a biocompatible calcium phosphate cement which is combined with a setting solution to form a moldable putty/paste that sets in the body to form a composite. It is supplied sterile in single use kits having volumes appropriate to the surgical site, and is intended to fill bony voids or defects of the skeletal system.
Adding Setting (Not Time Dependent)
- Carefully dispense all of the setting liquid from the dispensing tube into the mixing bowl with the calcium phosphate powder. Care should be taken to not dispense too quickly and cause powder to blow out of the bowl.
Mixing (0-60 Seconds)
- Mix the liquid and Ca/P powder thoroughly until a cohesive putty/paste is formed and the liquid is evenly distributed.
- This step is no longer than 1 minute.
Handling (1-4:30 Minutes)
- Once the paste/putty is formed, it is now moldable and can be transferred into the defect.
- The delivery device may be used.
- See IFU for specific instructions if use of delivery device is desired.
- All material must be transferred to defect site before hardening commences.
Setting (4:30-15 Minutes)
- Timing is important.
- Depending on room temperature, the cement begins to set at 4.5 minutes after the initiation of mixing.
- Cement sets within 15 minutes of initial mixing.
Vivorté, Inc. Trabexus is a moldable, self-setting, gradually resorbable calcium phosphate bone void filler. Trabexus is intended for use to fill bony voids or defects of the skeletal system (i.e. extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bone voids or defects that are not intrinsic to the stability of the bony structure. Trabexus may be manually applied to the bony defect or applied to the defect through a cannula. Trabexus is resorbed and remodeled by the body as new bone formation occurs during the healing process.
Trabexus is not designed or sold for any use except as indicated. Do not use Trabexus in the presence of any contraindication. These conditions include but are not limited to:
- Use in a currently infected field or surgical site near an infection.
- Use in patients with acute traumatic injuries with open wounds near the defect that is likely to become infected.
- Use in areas where surrounding bone is non-viable or is incapable of supporting or anchoring the implant.
- Use in patients with abnormal calcium metabolism, metabolic bone disease, a recent untreated infection, immunologic abnormalities, inflammatory bone disease, and / or systemic disorders which result in poor wound healing or which result in tissue deterioration over the implant site.
- Use in patients who have not reached an age at which skeletal system growth is essentially complete.
- Use in patients with fractures or voids that link joint spaces and/or articulating surfaces.
- Use in both vertebroplasty and kyphoplasty procedures.
- Use in patients with known sensitivity to bacitracin, antibiotics, gentamicine, polymixin, B sulfate or alcohol. These solutions / chemicals are used as a part of bone processing and may be present in trace amounts.
|High Compressive Strength||Demonstrates a maximum compressive strength five times greater than other DBM containing bone void fillers on the market.* It reaches strength of 40 MPa or greater, which is much stronger than cancellous bone.**|
|Heightened Osteoconductivity||Provides a scaffold for new bone growth that is perpetuated by native bone without compromising strength.|
|Optional Use of Delivery Tool||Provides device versatility for various surgical procedures that may or may not require the tool during implantation.|
|Isothermic Hardening||Eliminates potential thermal damage to surrounding soft tissue.|
|Sizes||3cc, 5cc, 10cc|
* Data on file at Vivorté, Inc
** Athanasiou, K. A., C.-F. Zhu, D. R. Lanctot, C. M. Agrawal, and X. Wang. “Fundamentals of Biomechanics in Tissue Engineering of Bone.” Tissue Engineering 6.4 (2000): 361-81.