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HEALICOIL KNOTLESS

Suture Anchors for Shoulder Repair

HEALICOIL Suture Anchor for Shoulder

Product Overview

Open architecture meets advanced healing

Redefining healing potential in rotator cuff repair1,2 with an additional fixation point3 and superior bone resorption4-6

Joining the HEALICOIL REGENESORB◊ Suture Anchor, the HEALICOIL KNOTLESS Suture Anchor combines our proprietary open architecture design, REGENESORB◊ material, and unique mechanism of action to help promote secure fixation,3 pull-out strength,7 and bone healing.1,2

  • Additional fixation point – interference fixation and an interlocking peek plug (HEALICOIL KNOTLESS Suture Anchor only)
  • Open architecture design – to reduce implanted material and facilitate better bony in-growth than traditional, solid-core anchors2,6,8
  • Unique REGENESORB material – shown to be absorbed and replaced with bone in 24 months*9-11

Watch how HEALICOIL KNOTLESS Suture Anchor works, and how to use it:

How is the HEALICOIL KNOTLESS Suture Anchor different?

Proprietary design and unique composition help it stand apart from other devices:

Less suture displacement during cyclic loading than competitors7

In cyclic loading testing over 500 cycles, the HEALICOIL KNOTLESS Suture Anchor demonstrated:

  • 69% less suture displacement than the Arthrex BioComposite Swivelock® 5.5mm Self-Punching (SP)**7
  • 94% less suture displacement than the Healix Advance™ 5.5mm SP Biocomposite Anchor.***7

Proven internal locking mechanism3

For an additional point of fixation, the suture is securely locked in place by descending a plug into the distal implant****3

The HEALICOIL Family – redefining healing potential

The most open architecture design, compared to competitors8

Designed to reduce the amount of implant material

Facilitates better bony in-growth six months after rotator cuff repair, compared to non-vented, solid-core anchors.2,6 Increased bone density around the anchor may contribute to higher pull-out strength and potentially reduce repair failure.2

Potential biologic healing advantage1,2

Allowing bone marrow and associated stem cells to enter the repair site may facilitate healing.1,2

 

May facilitate greater rotator cuff thickness1

Compared to the Healix Advance™ Suture Anchor, mean rotator cuff thickness at six weeks was significantly greater. *****1

 

“The real advantage of the [HEALICOIL] open architecture is that the stem cells from the bone marrow can reach the bone-tendon interface to promote healing where it is most needed.”

Jan Vonhoegen, MD Specialist for Orthopaedics and Trauma Surgery

Less foreign material than competitors*****7

  • 20% less material volume than Arthrex BioComposite SwiveLock® 4.75mm SP
  • 40% less than Arthrex BioComposite SwiveLock® 5.5mm SP
  • 62% less than Healix Advance™ 5.5mm SP Biocomposite Anchor

“The HEALICOIL anchor leads to more robust healing of that tendon to the bone.”

Ian Lo, MD FRCS(C)
Assistant Professor, University of Calgary 

Designed to provide a jump start in bone healing and formation

The only rotator cuff repair suture anchors to feature REGENESORB material – a unique biocomposite with three components and a unique physical and biochemical mechanism of action.12-20

 

“The REGENESORB material has three different components. In the ultrasound study that we did, you can actually see the bone growing across the coils of that vented anchor – and that’s related to the extra components, providing biologic stimulation.” 

Felix H. “Buddy” Savoie III MD
Chairman of Orthopaedic Surgery & Chief of Sports Medicine. Tulane University School of Medicine, New Orleans, LA

Read how REGENESORB material has performed over extensive clinical use.

An integral part of the advanced healing solutions portfolio

REGENETEN Bioinductive Implants for rotator cuff repair – suitable for a range of tear types.

Need help?

For additional information, or for help choosing the right advanced healing solution, please contact us.

*In vivo animal testing has demonstrated that the composite material is bio-absorbable and is replaced by bone. Data based on micro CT.

**As demonstrated in benchtop testing; p = 0.002

***As demonstrated in benchtop testing; p < 0.001; All Healix Advance 5.5 mm SP Biocomposite Anchors failed to complete the cyclic loading due to suture slipping within the anchor construct under the maximum cyclic load of 45 N

****As demonstrated in benchtop testing

*****40 patients vented vs thirty patients non-vented. 37.5% of the vented anchor group were female vs 50% of the non-vented group being female. Average days between surgery and follow up in the vented group and non-vented group were 42.1 and 40.8 respectively. Average age of the vented group was 55.0 years vs. 62.5 in the non-vented cohort. Average thickness for the vented group was 0.59 centimetres and 0.48 centimetres for the non-vented group (p-value 0.0074). Rotator cuff thickness was significantly associated with implant type, patient’s age (r = -0.42, p = 0.0003), and days post-op (r = 0.34, p = 0.0043).

 

References:
1. Clark TR, Guerrero EM, Song A, O’Brien MJ, Savoie FH. Do Vented Suture Anchors Make a Difference in Rotator Cuff Healing. Ann Sports Med Res. 2016, 3(3): 1068.
2. Chahla J, Liu JN, Manderle B, et al. Bony Ingrowth of Coil-Type Open-Architecture Anchors Compared With Screw-Type PEEK Anchors for the Medial Row in Rotator Cuff Repair: A Randomized Controlled Trial. Arthroscopy. 2020;36(4):952-961.
3. Data on file at Smith+Nephew, internal report no. 15009718, 2020
4. Barnes G. A Unique Formulation of Materials with Long Histories of Clinical Use. REGENSORB Absorbable Biocomposite Material, 2013.
5. Data on file at Smith+Nephew, report 1500879, 2012.
6. Kim JH, Kim YS, Park I, Lee HJ, Han SY, Jung S, SHin SJ. A Comparison of Open-Construct PEEK Suture Anchor and Non-Vented Biocomposite Suture Anchor in Arthroscopic Rotator Cuff Repair: A Prospective Randomized Clincial Trial. Arthroscopy. 2020, 36 (2): 389-396.
7. Data on file at Smith+Nephew, internal report no. 15009719, 2020.
8. Data on file at Smith+Nephew, internal report no. 15009720, 2020.
9. Vonhoegen J, John D, Hägermann C. Osteoconductive resorption characteristics of a novel biocomposite suture anchor material in rotator cuff repair. Orthop Traumatol Surg Res. 2019;14(1):12.
10. Smith + Nephew 2010. Micro-CT and histological evaluation of specimens from resorbable screw study (RS-II / OM1-08) 24-month post-implantation. Internal Report WRP-TE045-700-08.
11. Smith + Nephew 2016. Healicoil Regenesorb Suture Anchor – a study to assess implant replacement by bone over a 2 year period. NCS248.
12. Walsh WR, Morberg P, Yu Y, Response of a Calcium Sulfate Bone Graft Substitute in a Confined Cancellous Defect, Clin. Orthop. Rel. Res. 2003 Jan;(406):228-36.
13. Constantino, Friedman. Synthetic Bone Graft Subsitutes Otolaryngol Clin North Am. 1994 27(5):1037-1074.
14. Arai E, Nakashima H, Tsukushi S, et al. Regenerating the fibula with beta-tricalcium phosphate minimizes morbidity after fibula resection. Clin Orthop Relat Res. 2005(431):233-237.
15. Gaasbeek RD, Toonen HG, van Heerwaarden RJ, Buma P. Mechanism of bone incorporation of beta-TCP bone substitute in open wedge tibial osteotomy in patients. Biomaterials. 2005;26(33):6713-6719.
16. Chu C-C. Section IV:44, Biodegradable Polymeric Biomaterials: An Updated Overview. In: The Biomedical Engineering Handbook: Bronzino JD Ed. CRC Press.; 1995.
17. Park K, Skidmore S, Hadar J, et al. Injectable, long-acting PLGA formulations: Analyzing PLGA and understanding microparticle formation. J Control Release. 2019;304:125-134.
18. Milewski MD, et al. Bone replacement of fast-absorbing biocomposite anchors in arthroscopic shoulder labral repairs. The American Journal of Sports Medicine. 2012;40(6):1392-401.
19. Arthrex Inc. BioComposite SutureTak, BioComposite Corkscrew FT and BioComposite PushLock: An In Vitro Degradation Study, 2009.
20. Ogose A, Kondo N, Umezu H, et al. Histological assessment in grafts of highly purified beta-tricalcium phosphate (OSferions) in human bones. Biomaterials. 2006;27(8):1542-1549.

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