HEALICOIL REGENESORB Suture Anchor V1 07/14

Transcription

1 HEALICOIL REGENESORB Suture Anchor V1 07/14

2 Criteria for the Ideal Bioabsorbable Implant 1. Provides adequate initial fixation strength to heal the soft tissues to bone 2. Maintains satisfactory strength over time while the healing tissues are regaining mechanical integrity 3. Made of materials that are completely safe: no toxicity, antigenicity, pyrogenicity, or carcinogenicity 4. Must not bioabsorb too slowly or it will behave like its metal counterpart with potential breakage and migration 5. Is replaced by bone 1. Speer KP, Warren RF. Arthroscopic shoulder stabilization: a role for biodegradable materials. Clin Orthop Relat Res. 1993;291: Milewski, MD, Diduch, DR, Hart, JM, Tompkins M, Ma SY, Gaskin, CM. Bone Replacement of Fast-Absorbing Biocomposite Anchors in Arthroscopic Shoulder. Labral Repairs American Journal of Sports Medicine. 2012;40( 6):

3 Innovation Through Design and Material The HEALICOIL REGENESORB Suture Anchor is a unique combination of design and material which raises the bar for soft tissue fixation. Keeping all the advantages of the unique openarchitecture HEALICOIL PK design, the HEALICOIL Suture Anchor is now available in our new advanced REGENESORB biocomposite material. 3

4 HEALICOIL REGENESORB Suture Anchor Benefits of an innovative, open architecture design Bone ingrowth Open architecture allows blood and bone marrow from surrounding cancellous bone to enter implant, resulting in bone ingrowth by 12 weeks post implantation, as demonstrated in pre-clinical studies 1 Reduced material HEALICOIL RG Open Closed Competitive Anchor Open Closed Less implanted material and a greater % of open anchor area compared to competitive, solid-core anchors 1, permitting easier revision when necessary Superior pullout strength Open core allows for more threaded engagement than leading competitive biocomposite anchors in poor bone quality 2 Maintains fixation strength throughout the healing period 3 Superior torsional strength Inserter engages 100% the anchor s length, minimizing stress and providing superior insertion into hard bone compared to leading competitive biocomposite anchors 2 Ease of insertion Double-lead thread design reduces number of rotations required compared to anchors with a single lead thread design Note: Animal, in vitro and pre-clinical testing 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. 1. Data on file at Smith & Nephew in Validation Reports and in WRP TE Data on file at Smith & Nephew in Validation Reports Data on file at Smith & Nephew in Validation Report

5 The First Suture Anchor to Demonstrate Bone Ingrowth Through the Anchor 1 Open architecture design of HEALICOIL suture anchors allows blood and bone marrow from surrounding cancellous bone to enter implant, resulting in bone ingrowth into the fenestrations between threads and into the central channel 1. In a pre-clinical ovine study, the HEALICOIL PK Suture Anchor contained 63% of the bone volume found in an undisturbed area of bone by 12 weeks post-implantation Bone growing across implant Histology Micro-CT 1. All data is on file at Smith & Nephew in Validation and in WRP TE 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. 5

6 Superior Pullout Strength Extended, fully-threaded design provides more threaded engagement than leading competitive biocomposite anchors, delivering greater pullout strength in poor-quality, osteoporotic bone. 1 Effective thread purchase as seen from a bird s-eye view of the HEALICOIL PK Suture Anchor (cadaveric study, post insertion) Minimal size, maximal strength In biomechanical testing, the 4.75 mm HEALICOIL REGENESORB Suture Anchor demonstrated 10-12% higher pullout strength than larger, 5.5 mm competitive anchors Data on file at Smith & Nephew in Validation Reports and 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). 6

7 Sustained Fixation Strength for Healing HEALICOIL REGENESORB Suture Anchor 1. NO fixation strength lost over the first 12 week period 1 of in vitro degradation testing 2. Retains adequate strength over 26 weeks 1 of in vitro degradation testing, or twice the healing period necessary for rotator cuff repair. 3. Even after 12 weeks of in vitro degradation, the HEALICOIL REGENESORB Suture Anchor has statistically equivalent fixation strength 2 compared to a competitive anchor s Time-0 strength (i.e. pre-degradation). Statistically equivalent to Time-0 strength of Mitek Healix BR, even after 12 weeks of degradation Note: testing conducted in 5pcf bone blocks Note: In vitro testing 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. 1. Data on file at Smith & Nephew in Validation Report Data on file at Smith & Nephew in Validation Reports and

8 Superior Torsional Strength The HEALICOIL REGENESORB anchor provides predictable insertion into hard bone by distributing torque along the entire length of the anchor. Inserter engages 100% of the anchor s length Minimal size, maximal strength In biomechanical testing, the 4.75 mm HEALICOIL REGENESORB Suture Anchor demonstrated significantly higher (3-5x) torsional strength than larger, 5.5 mm competitive anchors 1 1. Data on file at Smith & Nephew in Validation Reports and 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). 8

9 REGENESORB: Innovation Through Material Smith & Nephew s latest biocomposite material Replaced by bone within 24 months in pre-clinical studies 1 Dual osteoconductive calcium components 1. In vivo animal testing has demonstrated that the composite 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 mm 3 ) was significantly greater (p<0.05) than bone in-growth into an empty defect (170.2mm 3 ) and reaches a bone volume not statistically different from intact bone (188.2 mm 3 ). Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at Smith & Nephew in report

10 REGENESORB Biocomposite Material Reliable Benefits of the advanced biocomposite material Unique formulation of proven materials, each with proven safety and biocompatibility over decades of clinical use 1 REGENESORB safety has been demonstrated in a Japanese human clinical trial evaluating REGENESORBbased instability anchors for shoulder labral repair 2 Innovative Bone Regeneration Rate CS β-tcp Shorter-term Longer-term Contains dual osteoconductive calcium components β-tcp and calcium sulfate which have been individually shown to act during different stages of bone healing 3 6 months 12 months 18 months 24 months Replaced by bone within 24 months in pre-clinical studies 3 9x10mm REGENESORB interference screw evaluated in direct-in-bone sheep model 1. Peltier et al. Ann Surg (1957) Vol. 146(1) and Suchenski et al. Arthroscopy (2010) Vol. 26(6) 2. Smith & Nephew Clinical Study Report for Protocol No. SNE-CL Costantino PD, Friedman CD. Synthetic Bone Graft Substitutes. Craniofacial Skeletal Augmentation and Replacement (1994) 27(5): In vivo animal testing has demonstrated that the composite 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 mm 3 ) was significantly greater (p<0.05) than bone in-growth into an empty defect (170.2mm 3 ) and reaches a bone volume not statistically different from intact bone (188.2 mm 3 ). Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at Smith & Nephew in report

11 HEALICOIL REGENESORB Suture Anchors Ordering Information Reference # Description HEALICOIL REGENESORB 4.75 mm Suture Anchor with two ULTRABRAID sutures (Blue, Cobraid Blue) HEALICOIL REGENESORB 5.5 mm Suture Anchor with two ULTRABRAID sutures (Blue, Cobraid Blue) HEALICOIL REGENESORB 5.5 mm Suture Anchor with three ULTRABRAID sutures (Blue, Cobraid Blue, Cobraid Black) Accessory Devices Reference # Description HEALICOIL REGENESORB 4.75 mm Fully Threaded Dilator, Reusable HEALICOIL REGENESORB 5.5 mm Fully Threaded Dilator, Reusable HEALICOIL REGENESORB 4.75 mm Fully Threaded Dilator, Disposable HEALICOIL REGENESORB 5.5 mm Fully Threaded Dilator, Disposable mm HEALICOIL Spade Tip Drill for use with the 4.75 mm HEALICOIL Suture Anchor mm HEALICOIL Spade Tip Drill for use with the 5.5 mm HEALICOIL Suture Anchor Trademark of Smith & Nephew. Registered US Patent and Trademark Office. All Trademarks acknowledged. 11

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