HEALICOIL Suture Anchor

Suture Anchor for Shoulder

 

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Product Overview

The HEALICOIL Suture Anchor Family

Open to more possibilities through a unique combination of innovative design and materials – PEEK or REGENESORB. The open-architecture HEALICOIL Suture Anchor and the inherent advantages of its design are now available in our new advanced REGENESORB biocomposite material.

Unique, open-architecture design.

The HEALICOIL Suture Anchor has a distinctive open-architecture that differs from solid-core implants by eliminating the material between the anchor threads. The open design allows blood and bone marrow from surrounding cancellous bone to enter the implant.

Bone ingrowth.

The unique HEALICOIL open architecture allows for new bone to fill the fenestrations between the threads and into the central channel by 12 weeks post-implantation, as demonstrated in a pre-clinical ovine study.1

HEALICOIL PK Suture Anchor: Bone-fill at 12 weeks in a pre-clinical ovine study.

 
Micro-CT images at 12 weeks of a 5.5 mm HEALICOIL PK Suture Anchor show a web of bone beginning to fill the center of the implant. Histology at the same point in time clearly demonstrates bone growing across the implant’s open architecture. 
Note: Testing conducted in 5pcf bone block; 5pcf bone density is equivalent to the worst-case, poorest-quality decorticated humeral bone. (pcf = pounds per cubic feet).


Less material.

The unique open-architecture design of HEALICOIL anchors reduces the amount of implanted material in the shoulder compared to traditional, solid-core anchors, permitting easier revision when necessary.2


Designed for durability

Even with its reduced volume of material, the HEALICOIL REGENESORB Suture Anchor meets the demanding biomechanical specifications of the most advanced surgical implants, providing the benefits of an absorbable implant with fixation strength comparable to non absorbable PEEK implants.3 And when compared to competitive biocomposite suture anchors, its superior biomechanical
performance includes stronger fixation security in poor-quality bone, and greater torsional strength – essential when inserting the anchor into harder bone densities.4

Superior pullout strength in poor-quality bone

 The extended, fully-threaded HEALICOIL REGENESORB anchor design provides more threaded engagement than leading competitive biocomposite anchors, delivering greater pullout strength in poor-quality, osteoporotic bone.5*

Minimal size, maximal strength.

In biomechanical testing, the 4.75 mm HEALICOIL REGENESORB Suture Anchor demonstrated higher pullout strength than the larger, 5.5 mm competitive anchors shown in the accompanying graph.6

Note: Testing conducted in 5pcf bone block; 5pcf bone density is equivalent to the worst-case, poorest-quality decorticated humeral bone. (pcf = pounds per cubic feet).


Sustained fixation strength for healing

The initial strength of the HEALICOIL REGENESORB Suture Anchor is designed to hold fixation over time throughout the healing period in poor quality bone7, withstanding typical shoulder loading forces and supporting the range of motion necessary for physical therapy and rehabilitation.

Superior torsional strength for insertion into bone

The HEALICOIL  inserter engages 100% the anchor’s length, minimizing stress and providing predictable insertion into hard bone by distributing torque along the entire length of the anchor.
 

Minimal size, maximal strength.

In biomechanical testing, both the 5.5 mm and 4.75 mm HEALICOIL REGENESORB Suture Anchor demonstrated significantly higher torsional strength than the 5.5 mm competitive anchors.8


Note: Testing conducted in 30pcf bone block; 30pcf bone density is equivalent to hard bone density – e.g. young, male athlete. (pcf = pounds per cubic feet)


*The information contained in this document is based on pre-clinical testing, which is not necessarily indicative of human clinical outcomes

 References
1. Validation 15001193 and in WRP TE024-94. Note: Animal data is not necessarily indicative of human clinical outcomes. These results have not been demonstrated in humans having a variety of bone quality based on specific disease states such as osteoporosis. The effect of formation of new bone on pullout strength was not shown.
2. See note 1 above.
3. Data on file at Smith & Nephew in reports 15001873 and 15002036.
4. Report Number 15002036 HEALICOIL Suture Anchor competitive testing. Data on file. August 2013.
5. See note 4 above.
6. See note 4 above.
7. Data on file at Smith and Nephew in report 15001609.
8. See note 4 above.
9. In vivo animal testing has demonstrated that REGENESORB material is bioabsorbable and is replaced by bone. Implants (9x10 mm) were implanted in ovine cancellous bone and compared to an empty defect (9x10 mm) at 6, 12, 18, and 24 months (n=6). Micro-CT analysis demonstrated that by 24 months, bone in-growth into this material (289.5 mm3) was significantly greater (p<0.05) than bone in-growth into an empty defect (170.2mm3) and reaches a bone volume not statistically different from intact bone (188.2 mm3). Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at Smith & Nephew in report 15000897.
10. In vivo animal testing has demonstrated that the composite material is bioabsorbable and is replaced by bone. Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at S&N in report # 15001194.
11. Data on file at Smith & Nephew in reports 15000897, 15001194, 15000921, 15000919.
12. Costantino and Friedman (1994) Otolaryngol Clin North Am. 1994 Oct;27(5)
13. Ogose et al (2006) Biomaterials Vol. 27(8).
14. See note 12 above.
15. Walsh et al (2003) Clin. Orthop. Rel. Res. Vol 406, Allison Et al (2011) US Oncology and Hematology Vol 7(1).
16. Suchenski et. al. (2010) J. Arthro. and Rel. Surg. Vol. 26(6).
17. Chih-Chu Chang, Section IV:44, “Biodegradable Polymeric Biomaterials” in The Biomedical Engineering Handbook. Bronzino JD Ed. CRC Press.
18. See note 12 above.
19. See note 13 above.
20. See note 12 above.
21. Pietrzak and Ronk (2000) J Craniofacial Surg. Vol 11(4).
22. See note 15 above.
23. See note 9 above.

REGENESORB Material

REGENESORB Material

An advanced biocomposite absorbed and completely replaced by bone within 24 months in pre-clinical studies.9 Developed by Smith & Nephew’s Advanced Healing Technologies group, REGENESORB biocomposite material contains PLGA and dual osteoconductive components, β-TCP and calcium sulfate.


 
 

Unique formulation of proven materials

REGENESORB biocomposite material is a unique formulation of PLGA, β-TCP, and calcium sulfate – each of which has been proven safe and biocompatible over decades of clinical use. The safety of REGENESORB material has been confirmed through several pre-clinical studies.11


Calcium sulfate: the material difference

Most biocomposite materials rely solely on the osteoconductive properties of β-TCP, which provides sustained bone formation over 18 months12 and acts primarily as a scaffold for enhancing new bone formation.13 But REGENESORB material includes a second osteoconductive material, calcium sulfate, which has been shown to work in the early stages (4-12 weeks) of bone healing14 and is associated with increased levels of local growth factors.15 So REGENESORB material contains two osteoconductive components – β-TCP and calcium sulfate – which have been individually shown to act during a different stage in the bone healing process and through different mechanisms of action – physical and biochemical.  

* The information contained in this document is based on pre-clinical testing, which is not necessarily indicative of human clinical outcomes

References

1. Validation 15001193 and in WRP TE024-94. Note: Animal data is not necessarily indicative of human clinical outcomes. These results have not been demonstrated in humans having a variety of bone quality based on specific disease states such as osteoporosis. The effect of formation of new bone on pullout strength was not shown.
2. See note 1 above.
3. Data on file at Smith & Nephew in reports 15001873 and 15002036.
4. Report Number 15002036 HEALICOIL Suture Anchor competitive testing. Data on file. August 2013.
5. See note 4 above.
6. See note 4 above.
7. Data on file at Smith and Nephew in report 15001609.
8. See note 4 above.
9. In vivo animal testing has demonstrated that REGENESORB material is bioabsorbable and is replaced by bone. Implants (9x10 mm) were implanted in ovine cancellous bone and compared to an empty defect (9x10 mm) at 6, 12, 18, and 24 months (n=6). Micro-CT analysis demonstrated that by 24 months, bone in-growth into this material (289.5 mm3) was significantly greater (p<0.05) than bone in-growth into an empty defect (170.2mm3) and reaches a bone volume not statistically different from intact bone (188.2 mm3). Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at Smith & Nephew in report 15000897.
10. In vivo animal testing has demonstrated that the composite material is bioabsorbable and is replaced by bone. Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at S&N in report # 15001194.
11. Data on file at Smith & Nephew in reports 15000897, 15001194, 15000921, 15000919.
12. Costantino and Friedman (1994) Otolaryngol Clin North Am. 1994 Oct;27(5)
13. Ogose et al (2006) Biomaterials Vol. 27(8).
14. See note 12 above.
15. Walsh et al (2003) Clin. Orthop. Rel. Res. Vol 406, Allison Et al (2011) US Oncology and Hematology Vol 7(1).
16. Suchenski et. al. (2010) J. Arthro. and Rel. Surg. Vol. 26(6).
17. Chih-Chu Chang, Section IV:44, “Biodegradable Polymeric Biomaterials” in The Biomedical Engineering Handbook. Bronzino JD Ed. CRC Press.
18. See note 12 above.
19. See note 13 above.
20. See note 12 above.
21. Pietrzak and Ronk (2000) J Craniofacial Surg. Vol 11(4).
22. See note 15 above.
23. See note 9 above.

References

References

The information contained in this document is based on pre-clinical testing, which is not necessarily indicative of human clinical outcomes.

1. Validation 15001193 and in WRP TE024-94. Note: Animal data is not necessarily indicative of human clinical outcomes. These results have not been demonstrated in humans having a variety of bone quality based on specific disease states such as osteoporosis. The effect of formation of new bone on pullout strength was not shown.
2. See note 1 above.
3. Data on file at Smith & Nephew in reports 15001873 and 15002036.
4. Report Number 15002036 HEALICOIL Suture Anchor competitive testing. Data on file. August 2013.
5. See note 4 above.
6. See note 4 above.
7. Data on file at Smith and Nephew in report 15001609.
8. See note 4 above.
9. In vivo animal testing has demonstrated that REGENESORB material is bioabsorbable and is replaced by bone. Implants (9x10 mm) were implanted in ovine cancellous bone and compared to an empty defect (9x10 mm) at 6, 12, 18, and 24 months (n=6). Micro-CT analysis demonstrated that by 24 months, bone in-growth into this material (289.5 mm3) was significantly greater (p<0.05) than bone in-growth into an empty defect (170.2mm3) and reaches a bone volume not statistically different from intact bone (188.2 mm3). Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at Smith & Nephew in report 15000897.
10. In vivo animal testing has demonstrated that the composite material is bioabsorbable and is replaced by bone. Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at S&N in report # 15001194.
11. Data on file at Smith & Nephew in reports 15000897, 15001194, 15000921, 15000919.
12. Costantino and Friedman (1994) Otolaryngol Clin North Am. 1994 Oct;27(5)
13. Ogose et al (2006) Biomaterials Vol. 27(8).
14. See note 12 above.
15. Walsh et al (2003) Clin. Orthop. Rel. Res. Vol 406, Allison Et al (2011) US Oncology and Hematology Vol 7(1).
16. Suchenski et. al. (2010) J. Arthro. and Rel. Surg. Vol. 26(6).
17. Chih-Chu Chang, Section IV:44, “Biodegradable Polymeric Biomaterials” in The Biomedical Engineering Handbook. Bronzino JD Ed. CRC Press.
18. See note 12 above.
19. See note 13 above.
20. See note 12 above.
21. Pietrzak and Ronk (2000) J Craniofacial Surg. Vol 11(4).
22. See note 15 above.
23. See note 9 above.

Ordering Information

HEALICOIL REGENESORB Suture Anchor

Reference # Description
72203704 HEALICOIL REGENESORB 4.75 mm Suture Anchor with two ULTRABRAID sutures (Blue, Cobraid Blue)
72203706 HEALICOIL REGENESORB 5.5 mm Suture Anchor with two ULTRABRAID sutures (Blue, Cobraid Blue)
72203707 HEALICOIL REGENESORB 5.5 mm Suture Anchor with three ULTRABRAID sutures (Blue, Cobraid Blue, Cobraid Black)
   
Accessory Devices  
72203709 HEALICOIL REGENESORB 4.75 mm Fully Threaded Dilator,Reusable
72203710 HEALICOIL REGENESORB 5.5 mm Fully Threaded Dilator, Reusable
72203951 HEALICOIL REGENESORB 4.75 mm Fully Threaded Dilator, Disposable
72203952 HEALICOIL REGENESORB 5.5 mm Fully Threaded Dilator, Disposable
72203482 3.5 mm HEALICOIL Spade Tip Drill for use with the 4.5/4.75 mm HEALICOIL Suture Anchor
72203483 4.5 mm HEALICOIL Spade Tip Drill for use with the 5.5 mm HEALICOIL Suture Anchor

HEALICOIL PK Suture Anchor

Reference # Description
72203378 4.5 mm HEALICOIL PK Suture Anchor with two ULTRABRAID (#2) Sutures (blue, blue-Cobraid), sterile
72203379 5.5 mm HEALICOIL PK Suture Anchor with two ULTRABRAID (#2) Sutures (blue, blue-Cobraid), sterile
72203380 5.5 mm HEALICOIL PK Suture Anchor with three ULTRABRAID (#2) Sutures (blue, blue-Cobraid, Cobraid-black), sterile
   
Accessory Devices  
72202621 3.8 mm Tapered Awl, disposable
72201915 3.8 mm Tapered Awl, reusable
72202633 4.5 mm HEALICOIL/TWINFIX ULTRA Threaded Dilator, reusable
72202634 5.5 mm HEALICOIL/TWINFIX ULTRA Threaded Dilator, reusable
72203482 3.5 mm HEALICOIL Spade Tip Drill for use with the 4.5/4.75 mm HEALICOIL Suture Anchor
72203483 4.5 mm HEALICOIL Spade Tip Drill for use with the 5.5 mm HEALICOIL Suture Anchor