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Biocomposites announces new CE Mark for STIMULAN®

First calcium matrix to receive European approval as an antibiotic carrier for use in bone and soft tissue

STIMULAN®

Uniquely engineered for the precision and control you demand every time

Perfect partner for your infection management strategy

STIMULAN is a truly absorbable calcium sulfate antibiotic carrier – specifically designed to support the proactive management of dead space and surgical site infection with unrivalled flexibility and the broadest surgical application.¹

    • The only calcium matrix approved for use in bone and soft tissue
    • Suitable carrier for vancomycin, gentamicin and tobramycin
    • Freedom to select and source your preferred antibiotic*
    • Can be placed directly into infected and non-infected sites
    *Antibiotic is not supplied with the product. For indications, contraindications, warnings and precautions see Instructions for Use.

Bring the challenge of infection under your control

With the ability to mix substances according to the specific antimicrobial needs of each infection, STIMULAN combines flexibility with the predictability and consistency necessary to ensure sustained antibiotic cover.

Properties that drive performance

The unique crystal configuration and construction of STIMULAN brings its own set of qualities to fully support your infected cases.2

  • Controlled purity
  • No hydroxyapatite, insoluble impurities or PMMA debris
  • Easily mixed with liquid and powder antibiotics

See the STIMULAN difference in your cases

  • Completely absorbs at an optimal rate1,6-11
  • Does not cause third body damage19,20
  • Does not prevent use in articulating surfaces19,20
  • Does not act as a nidus for infection6-11
  • Low levels of drainage12-18
  • Flexibility to tailor antibiotic to clinical need4
  • Predictable, supra-therapeutic elution levels3
  • Proven action against biofilms5
Truly absorbable and totally synthetic calcium sulfate – absorbs at an optimal rate1,6-11

Leaves no nidus for infection.

Post-operative
1 month
11 weeks
6 months
No third body damage to articulating surfaces19,20

Less scratching than competitor calcium sulfate

STIMULAN does not damage total knee replacements when trapped between the articulating surfaces of the implant

Microscope images (x6.5) of a cobalt chrome plate following damage simulation(360,000 cycles) with third body particles trapped between it and an articulating UHMWPE pin

STIMULAN
Competitor calcium sulfate
Control
Flexibility to tailor antibiotic to clinical need4

Effective against a broad spectrum of pathogens

Predictable, supra-therapeutic elution profile3

Antibiotic levels sustained above MIC for over 40 days

Proven action against biofilms5

No viable organisms were recovered from pre-formed biofilms

 

Low levels of drainage12-18

 

Unrivalled evidence and expertise bring confidence

With our industry-leading knowledge, dedication and experience, you can be sure that the high level of consistency you demand in your cases will be met.

Consistency is hard earned and uniquely achieved

STIMULAN is uniquely engineered through our DRy26™ recrystallization method.2 Each and every synthesis undergoes a 26 step process that starts with pharmaceutical grade precursors and takes over 6 weeks to reach maturity.

Case-by-case flexibility

Every part of STIMULAN has been designed to provide simplicity, intra-operative flexibility and optimum results. A variety of formats are available, all convenient and fast to set

STIMULAN® products
STIMULAN® Rapid Cure

Rapid setting paste with individual bead kit.

  • Beads can be prepared in three sizes;
    3, 4.8 and 6mm
  • Available in 5cc, 10cc and 20cc packs (bead volume 12cc, 25cc and 50cc)
  • Rapid setting in approx. 4 minutes
STIMULAN® Kit

Standard setting, fully injectable paste with individual bead kit.

  • Beads can be prepared in three sizes;
    3, 4.8 and 6mm
  • Available in 5cc and 10cc packs (bead volume 10cc and 20cc)
  • Standard setting in approx. 8 minutes
STIMULAN - power to transform outcomes
How to prepare STIMULAN Rapid Cure
Hear what surgeons have to say about STIMULAN
Dr Hohman case study - tibial osteomyelitis
Dr Wassef case study - infected hip revision
Dr Webb case study - bilateral high energy femoral fractures
Hear what surgeons have to say about STIMULAN
Library

Listed below are 4 of the most relevant articles for this product but there is much more unrivalled evidence to explore on our Library page.

Explore Library
STIMULAN®
Transform diabetic foot
View case study >
STIMULAN®
Transform diabetic foot ulcer
View case study >
STIMULAN®
Transform diabetic foot ulcer
View case study >
STIMULAN®
Transform infected foot ulcer
View case study >

References and regulatory statements

1.Biocomposites, STIMULAN Rapid Cure/Kit Instructions for Use. 2. Cooper, J.J., Method of producing surgical grade calcium sulphate; Patent. 1999. 3. Cooper, J.J., S.S. Aiken, and P.A. Laycock, Antibiotic stability in a synthetic calcium sulphate carrier for local delivery, in 32nd annual meeting of the European Bone and Joint Infection Society. 2013: Prague, Czech Republic. 4. Laycock, P., et al., In Vitro Efficacy of Antibiotics Released from Calcium Sulfate Bone Void Filler Beads. Materials, 2018. 11(11): p. 2265. 5. Delury, C., et al., Determining the Efficacy of Antibiotic-loaded Calcium Sulfate Beads against Pre-Formed Biofilms: An In Vitro Study, in ASM Microbe. 2019: San Francisco, USA. Somasundaram, K., et al., Proximal humeral fractures: the role of calcium sulphate augmentation and extended deltoid splitting approach in internal fixation using locking plates. Injury, 2013. 44(4): p. 481-7. 7. Lei, D., et al., Treatment of Distal Radius Bone Defects with Injectable Calcium Sulphate Cement., in Bone Grafting, A. Zorzi, Editor. 2012, InTech. p. 125-134. 8. Lei, D., L. Jing, and S. Yang-yong, Calcium sulfate versus calcium phosphate in treating traumatic fractures. JOURNAL OF CLINICAL REHABILITATIVE TISSUE ENGINEERING RESEARCH., 2008. 12. 9. Lei, D., Z. Ma, and X. Jing, Treatment of bone defect with injectable calcium sulfate powder in distal fractures of radius. Chinese Journal of Bone Tumor and Bone Disease, 2007. 10. Aiken, S.S., J.J. Cooper, and S. Zhou, Osseointegration of a calcium sulphate bone substitute in a large animal model, in The 5th International Congress of Chinese Orthopaedic Association. 2010: Chengdu, China. 11. Lazarou, S.A., G.B. Contodimos, and I.D. Gkegkes, Correction of alveolar cleft with calcium-based bone substitutes. J Craniofac Surg, 2011. 22(3): p. 854-7. 12. McPherson, E.J., M.V. Dipane, and S.M. Sherif, Dissolvable Antibiotic Beads in Treatment of Periprosthetic Joint Infection and Revision Arthroplasty. The Use of Synthetic Pure Calcium Sulfate (Stimulan®)Impregnated with Vancomycin & Tobramycin. Reconstructive Review, 2013. 3(1): p. 32-43. 13. McPherson, E.J., Dissolvable Antibiotic Beads in Treatment of Periprosthetic Joint Infection. The Use of Synthetic Pure Calcium Sulfate (Stimulan®) Impregnated with Vancomycin & Tobramycin, in 2nd Annual Oxford Bone Infection Conference (OBIC). 2012: Oxford, UK. 14. Gauland, C., The use of antibiotic impregnated, implanted synthetic calcium sulphate tablets in the treatment of soft tissue, vancomycin resistant, enterococcus infections, in The Symposium on Advanced Wound Care and Wound Healing Society Annual Meeting. 2011: Gaylord Texan Hotel & Convention Center, Dallas, Texas. 15. Borrelli, J., Jr., W.D. Prickett, and W.M. Ricci, Treatment of nonunions and osseous defects with bone graft and calcium sulfate. Clin Orthop Relat Res, 2003(411): p. 245-54. 16. Helgeson, M.D., et al., Antibiotic-impregnated calcium sulfate use in combat-related open fractures. Orthopedics, 2009. 32(5): p. 323.  17. McKee, M.D., et al., The use of an antibiotic-impregnated, osteoconductive, bioabsorbable bone substitute in the treatment of infected long bone defects: early results of a prospective trial. J Orthop Trauma, 2002. 16(9): p. 622-7. 18. Noor, S., et al., The use of Osteoset-T in the treatment of chronic osteomyelitis of the tibia following exogenous trauma: A review of 22 patients at a regional trauma centre. Bone & Joint Journal Orthopaedic Proceedings Supplement, 2013. 95-B(SUPP 23): p. 4. 19. Analysis of the Wear Effect 3rd Body Particulate (Bone Cement) has on UHMWPE, Accutek Testing Laboratory, Fairfield OH, K13107732-1, 2014. 20. Cowie, R.M., et al., The influence of a calcium sulphate bone void filler on the third-body damage and polyethylene wear of total knee arthroplasty. Bone Joint Res, 2019. 8(2): p. 65-72.

For indications, contraindications, warnings and precautions see Instructions for Use. Concurrent use of locally administered antibiotics may affect setting time, absorption and/or bone formation. It is the surgeon/healthcare professional’s responsibility to give due consideration to the details in the medicinal product marketing authorization in deciding whether it is appropriate for the patient under his/her care. The relevant Summary of Product Characteristics (SmPC) must be consulted. The type and dose of medicinal substance should also be assessed according to the individual patient’s clinical circumstance.

This website may include the use of STIMULAN or techniques that go beyond the current clearance / approval granted by the relevant regulatory authority. Please contact your local representative for further information.

©2024, Biocomposites, STIMULAN, Bringing Calcium to Life, Power to Transform Outcomes and DRy26 are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorised copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.

Patents granted: GB2367552, EP 1204599 B1, US 6780391, EP 2594231 B1, US 88883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1, US 10390954

Patents pending: GB1502655.2, US 15/040075, CN 201610089710.5, GB1704688.9, EP 18275044.8, US 15/933936, CN 108619579A

MA0074R7/MA0252R3/MA0148R2