HEALICOIL◊ REGENESORB and HEALICOIL◊ PK
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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.