STIMULAN®

STIMULAN is a pharmaceutical-grade calcium sulfate that is the perfect partner for your infection management strategy – helping you to improve surgical outcomes and lower overall costs of care.

Perfect partner for your infection management strategy

STIMULAN is a truly absorbable calcium sulfate, specifically designed to complement your dead space and infection management strategies.1

  • Approved for placement directly at the site of infection

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Calcium sulfate uniquely recrystallised to transform outcomes

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Reference: 1. Biocomposites Ltd, STIMULAN Instructions for Use.

For indications, contraindications, warnings and precautions see Instructions for Use.  The treating physician is responsible for deciding the type and quantity of antibiotic used.  Concurrent use of locally administered antibiotics may affect setting time.

The mixing of antibiotics with the STIMULAN Kit / STIMULAN Rapid Cure device has not been assessed by a European medicines Competent Authority and is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare professional.

This page 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.

©2017, Biocomposites, STIMULAN, Bringing Calcium to Life and Power to Transform Outcomes 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 8883063, CN ZL201210466117.X, GB2496710

Patents pending: GB1502655.2, EP 16154210.5, US 15/040075, CN 201610089710.5, US 15/288328, GB1704688.9

Frequently Asked Questions

 

STIMULAN is indicated for use in musculoskeletal defects created by surgery, a cyst, a tumour, osteomyelitis or traumatic injury. STIMULAN is not intended to provide structural support during the healing process. It can be used at an infected site.
Contraindications for STIMULAN can be found in the IFU. These include contraindications for filling defects which are intrinsic to the stability of the bony structure, renal compromised patients, hypercalcaemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, severe degenerative bone disease and uncooperative patients who can't or won’t follow post-operative instructions including individuals who abuse alcohol or drugs.
STIMULAN is already used in over 20,000 cases a year. We are happy to introduce physicians to an appropriate surgeon if they would like to have a peer to peer conversation.
This is an area of ongoing research but biomechanical testing (pin on plate) indicates that STIMULAN does not significantly scratch implant grade cobalt chrome and does not lead to increased wear of high density polyethylene components, when compared to a control with no STIMULAN present.
STIMULAN is an osteoconductive material and is not osteoinductive or osteogenic in nature. Biocomposites has published a range of clinical data indicating a minimal risk of HO if implanted in soft tissue.
STIMULAN is a pharmaceutical-grade, synthetic calcium sulfate. The physical and chemical properties are tightly controlled through Biocomposites’ patented recrystallisation process to ensure optimum purity. Evidence has shown that STIMULAN is associated with reduced drainage rates when compared to non-synthetic calcium sulfates. Naturally occurring mineral sources of calcium sulfate can contain non absorbing earth impurities, may be of acidic pH and hydrophobic in nature, and are often linked to significant problems with wound healing and drainage.
Wound drainage may occur with any implanted material. STIMULAN has a low documented occurrence of wound drainage. It may be attributed to several factors including patient health and surgical methods e.g. 1) large volumes of STIMULAN beads placed in a concentrated area may cause stretching of the tissue envelope during normal range of motion and leakage at the wound site, 2) patients with comorbidities have a much greater probability of draining due to their poor tissue quality, which may not permit a watertight seal. To reduce the risk of drainage ensure complete soft tissue coverage and/or containment is achieved.

 

Recrystallised for improved clinical performance

STIMULAN has a unique crystal structure and properties.1,2

  • Controlled purity
  • Physiologic pH level
  • Hydrophilicity

Only STIMULAN undergoes a patented recrystallisation process that starts with pharmaceutical-grade reagents and results in its consistent and reliable performance.1–8

  • Truly absorbable at an optimal rate
  • No third body damage
  • Low levels of drainage

Truly absorbable and totally synthetic calcium sulfate – absorbs at an optimal rate1–5,8

Leaves no nidus for infection.

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Post-operative
1-month.png
1 month
2-weeks.png
11 weeks
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6 months

Low levels of drainage2–3, 6–7, 10–12

Drainage rates-01-01.png

No third body damage13
Less scratching than competitor calcium sulfate and PMMA.

third-body-damage

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

References: 1. Cooper JJ. Method of producing surgical grade calcium sulphate. 1999, Patent GB2367552; EP 1204599 BI; US 6780391. 2. McPherson EJ. Dissolvable antibiotic beads in treatment of periprosthetic joint infection - the use of synthetic pure calcium sulfate (STIMULAN®) impregnated with vancomycin and tobramycin. Presented at: Oxford Bone Infection Conference (OBIC) 2012. 3. McPherson EJ et al. Reconstructive Review 2013;3:32–43. 4. Cierny G et al. Comparing OsteoSet and STIMULAN as antibiotic-loaded, calcium sulfate beads in the management of musculoskeletal infection. Presented at: Musculoskeletal Infection Society of North America 2009. 5. Kallala R et al. Outcomes following use of antibiotic-eluting, absorbable, calcium sulfate beads in revision hip and knee surgery for periprosthetic infection. Presented at: International Society for Technology in Arthroplasty 2013. 6. Gauland C. The use of antibiotic impregnated, implanted synthetic calcium sulfate tablets in the treatment of soft tissue, vancomycin resistant enterococcus infections. Presented at: Wound Healing Society 2011. 7. Borrelli J, Jr et al. Clin Orthop Relat Res 2003;411:245–254. 8. Biocomposites Ltd, STIMULAN Instructions for use. 9. Cooper et al. Antibiotic stability in a synthetic calcium sulphate carrier for local delivery. Poster presented at European Bone and Joint infection Society Annual Meeting, Prague, Czech Republic, 2013. 10. Helgeson MD et al. Orthopedics 2009;32:323. 11. McKee MD et al. J Orthop Trauma 2002;16:622–627. 12. Noor S et al. Bone Joint J 2013;95-B:4. 13.Data on file.

For indications, contraindications, warnings and precautions see Instructions for Use.  The treating physician is responsible for deciding the type and quantity of antibiotic used.  Concurrent use of locally administered antibiotics may affect setting time.

The mixing of antibiotics with the STIMULAN Kit / STIMULAN Rapid Cure device has not been assessed by a European medicines Competent Authority and is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare professional.

This page 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.

©2017, Biocomposites, STIMULAN, Bringing Calcium to Life and Power to Transform Outcomes 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 8883063, CN ZL201210466117.X, GB2496710

Patents pending: GB1502655.2, EP 16154210.5, US 15/040075, CN 201610089710.5, US 15/288328, GB1704688.9



Frequently Asked Questions

 

STIMULAN is indicated for use in musculoskeletal defects created by surgery, a cyst, a tumour, osteomyelitis or traumatic injury. STIMULAN is not intended to provide structural support during the healing process. It can be used at an infected site.
Contraindications for STIMULAN can be found in the IFU. These include contraindications for filling defects which are intrinsic to the stability of the bony structure, renal compromised patients, hypercalcaemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, severe degenerative bone disease and uncooperative patients who can't or won’t follow post-operative instructions including individuals who abuse alcohol or drugs.
STIMULAN is already used in over 20,000 cases a year. We are happy to introduce physicians to an appropriate surgeon if they would like to have a peer to peer conversation.
This is an area of ongoing research but biomechanical testing (pin on plate) indicates that STIMULAN does not significantly scratch implant grade cobalt chrome and does not lead to increased wear of high density polyethylene components, when compared to a control with no STIMULAN present.
STIMULAN is an osteoconductive material and is not osteoinductive or osteogenic in nature. Biocomposites has published a range of clinical data indicating a minimal risk of HO if implanted in soft tissue.
STIMULAN is a pharmaceutical-grade, synthetic calcium sulfate. The physical and chemical properties are tightly controlled through Biocomposites’ patented recrystallisation process to ensure optimum purity. Evidence has shown that STIMULAN is associated with reduced drainage rates when compared to non-synthetic calcium sulfates. Naturally occurring mineral sources of calcium sulfate can contain non absorbing earth impurities, may be of acidic pH and hydrophobic in nature, and are often linked to significant problems with wound healing and drainage.
Wound drainage may occur with any implanted material. STIMULAN has a low documented occurrence of wound drainage. It may be attributed to several factors including patient health and surgical methods e.g. 1) large volumes of STIMULAN beads placed in a concentrated area may cause stretching of the tissue envelope during normal range of motion and leakage at the wound site, 2) patients with comorbidities have a much greater probability of draining due to their poor tissue quality, which may not permit a watertight seal. To reduce the risk of drainage ensure complete soft tissue coverage and/or containment is achieved.

 

Case-by-case flexibility

STIMULAN can be used in three sizes of bead, as a paste or for injection. Its hydrophilic properties and options of rapid or standard setting times make it quick and easy to prepare – helping you to adapt to each case as is merited. 

 

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Flexible formats to optimise dead space management

STIMULANPASTE VOLUMEBEAD VOLUMESETTING TIMEORDER CODES
Kit (standard setting)

Fully injectable paste
with individual bead kit
5 cc 10 cc

Approx.

8 minutes

600–005
10 cc 20 cc 600–010
         
Rapid Cure 

Rapid setting paste
with individual bead kit
5 cc 12 cc

Approx.

4 minutes

620–005
10 cc 25 cc 620–010
20 cc 50 cc 620–020

 

STIMULAN Bullet Mat and Introducer

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  • Simplify delivery into hard-to-reach defects.
  • Mould long bullets with a groove down one side to reduce the risk of pressurising the defect site.
  • Bullet can be prepared in two diameters – 7mm and 9mm for varying void sizes.

 

Bullet diameter

Outside diameter

of Introducer

Minimum reamed

diameter

End-to-end lengthOrder code
7mm 9mm (black handle) 10mm 640mm  660-001
9mm 11mm (silver handle) 12mm 480mm

For indications, contraindications, warnings and precautions see Instructions for Use.  The treating physician is responsible for deciding the type and quantity of antibiotic used.  Concurrent use of locally administered antibiotics may affect setting time.

The mixing of antibiotics with the STIMULAN Kit / STIMULAN Rapid Cure device has not been assessed by a European medicines Competent Authority and is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare professional.

This page 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.

©2018, Biocomposites, STIMULAN, Bringing Calcium to Life and Power to Transform Outcomes 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 8883063, CN ZL201210466117.X, GB2496710

Patents pending: GB1502655.2, EP 16154210.5, US 15/040075, CN 201610089710.5, US 15/288328, GB1704688.9.

 

Frequently Asked Questions

 

STIMULAN is indicated for use in musculoskeletal defects created by surgery, a cyst, a tumour, osteomyelitis or traumatic injury. STIMULAN is not intended to provide structural support during the healing process. It can be used at an infected site.
Contraindications for STIMULAN can be found in the IFU. These include contraindications for filling defects which are intrinsic to the stability of the bony structure, renal compromised patients, hypercalcaemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, severe degenerative bone disease and uncooperative patients who can't or won’t follow post-operative instructions including individuals who abuse alcohol or drugs.
STIMULAN is already used in over 20,000 cases a year. We are happy to introduce physicians to an appropriate surgeon if they would like to have a peer to peer conversation.
This is an area of ongoing research but biomechanical testing (pin on plate) indicates that STIMULAN does not significantly scratch implant grade cobalt chrome and does not lead to increased wear of high density polyethylene components, when compared to a control with no STIMULAN present.
STIMULAN is an osteoconductive material and is not osteoinductive or osteogenic in nature. Biocomposites has published a range of clinical data indicating a minimal risk of HO if implanted in soft tissue.
STIMULAN is a pharmaceutical-grade, synthetic calcium sulfate. The physical and chemical properties are tightly controlled through Biocomposites’ patented recrystallisation process to ensure optimum purity. Evidence has shown that STIMULAN is associated with reduced drainage rates when compared to non-synthetic calcium sulfates. Naturally occurring mineral sources of calcium sulfate can contain non absorbing earth impurities, may be of acidic pH and hydrophobic in nature, and are often linked to significant problems with wound healing and drainage.
Wound drainage may occur with any implanted material. STIMULAN has a low documented occurrence of wound drainage. It may be attributed to several factors including patient health and surgical methods e.g. 1) large volumes of STIMULAN beads placed in a concentrated area may cause stretching of the tissue envelope during normal range of motion and leakage at the wound site, 2) patients with comorbidities have a much greater probability of draining due to their poor tissue quality, which may not permit a watertight seal. To reduce the risk of drainage ensure complete soft tissue coverage and/or containment is achieved.

 

Transform outcomes

STIMULAN can transform outcomes in infected non-unions, osteomyelitis and periprosthetic joint infection.

 

diabetic foot_eu-01.pngTransform osteomyelitis in diabetic foot

Patient presented with: persistent osteomyelitis and interphalangeal joint destruction of left hallux. He was already receiving treatment for Charcot arthropathy to his right foot.

Outcome: 2 weeks post-operatively, the toe reduced in size. At the 16-month x-ray the patient was infection-free and amputation had been avoided. STIMULAN was seen to have completely absorbed at 4 months.

Click to read full case study

 

trauma_eu.01.pngTransform infected trauma

Patient presented with: infected femoral nail and non-union of left femur with persistent discharging wounds proximally and distally.

Outcome: At 7 months follow-up there was a complete healing of the non-union and at 1 year patient remains infection free, walking with no pain.

Click to read full case study

arthroplasty_eu-01.pngTransform infected revision arthroplasty

Patient presented with: infected total knee replacement 2 years after primary procedure.

Outcome: At 1 year follow-up the patient remains infection free and is under regular follow-up.

Click to read full case study

 

For indications, contraindications, warnings and precautions see Instructions for Use.  The treating physician is responsible for deciding the type and quantity of antibiotic used.  Concurrent use of locally administered antibiotics may affect setting time.

The mixing of antibiotics with the STIMULAN Kit / STIMULAN Rapid Cure device has not been assessed by a European medicines Competent Authority and is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare professional.

This page 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.

©2017, Biocomposites, STIMULAN, Bringing Calcium to Life and Power to Transform Outcomes 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 8883063, CN ZL201210466117.X, GB2496710

Patents pending: GB1502655.2, EP 16154210.5, US 15/040075, CN 201610089710.5, US 15/288328, GB1704688.9.

 

Frequently Asked Questions

 

STIMULAN is indicated for use in musculoskeletal defects created by surgery, a cyst, a tumour, osteomyelitis or traumatic injury. STIMULAN is not intended to provide structural support during the healing process. It can be used at an infected site.
Contraindications for STIMULAN can be found in the IFU. These include contraindications for filling defects which are intrinsic to the stability of the bony structure, renal compromised patients, hypercalcaemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, severe degenerative bone disease and uncooperative patients who can't or won’t follow post-operative instructions including individuals who abuse alcohol or drugs.
STIMULAN is already used in over 20,000 cases a year. We are happy to introduce physicians to an appropriate surgeon if they would like to have a peer to peer conversation.
This is an area of ongoing research but biomechanical testing (pin on plate) indicates that STIMULAN does not significantly scratch implant grade cobalt chrome and does not lead to increased wear of high density polyethylene components, when compared to a control with no STIMULAN present.
STIMULAN is an osteoconductive material and is not osteoinductive or osteogenic in nature. Biocomposites has published a range of clinical data indicating a minimal risk of HO if implanted in soft tissue.
STIMULAN is a pharmaceutical-grade, synthetic calcium sulfate. The physical and chemical properties are tightly controlled through Biocomposites’ patented recrystallisation process to ensure optimum purity. Evidence has shown that STIMULAN is associated with reduced drainage rates when compared to non-synthetic calcium sulfates. Naturally occurring mineral sources of calcium sulfate can contain non absorbing earth impurities, may be of acidic pH and hydrophobic in nature, and are often linked to significant problems with wound healing and drainage.
Wound drainage may occur with any implanted material. STIMULAN has a low documented occurrence of wound drainage. It may be attributed to several factors including patient health and surgical methods e.g. 1) large volumes of STIMULAN beads placed in a concentrated area may cause stretching of the tissue envelope during normal range of motion and leakage at the wound site, 2) patients with comorbidities have a much greater probability of draining due to their poor tissue quality, which may not permit a watertight seal. To reduce the risk of drainage ensure complete soft tissue coverage and/or containment is achieved.

 

STIMULAN Bullet Mat and Introducer

Hear what surgeons have to say

Dr Wassef case study

Infected hip revision with STIMULAN beads

Dr Webb case study

Bilateral high energy femoral fractures with STIMULAN beads

Technique Guide

See the STIMULAN Bullet Mat and Introducer in action

Testimonials

Hear what surgeons have to say about STIMULAN

Testimonials

Hear what surgeons have to say about STIMULAN

Testimonials

Hear what surgeons have to say about STIMULAN

How to prepare

STIMULAN Rapid Cure

Case studies

Read case studies for trauma

Case studies

Read case studies for musculoskeletal infections

Resources

  • STIMULAN brochure
  • STIMULAN preparation guide
  • FAQs