, Nov. 7, 2013
/PRNewswire/ -- Smith & Nephew (NYSE:SNN;LSE:SN), the global medical technology business, announced the US launch of the HEALICOIL
REGENESORB Suture Anchor at today's Arthroscopy Association of North America
(AANA) Fall Course in Las Vegas
. Building on the success of the innovative HEALICOIL PK design, this new suture anchor is the first device to use the company's proprietary REGENESORB material an advanced biocomposite that has been shown in pre-clinical studies to be absorbed and replaced by bone within 24 months.[i]
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"The HEALICOIL REGENESORB Suture Anchor is a perfect marriage of implant design and material," says orthopaedic surgeon, Scott Trenhaile, Clinical Assistant Professor of Surgery, University of Illinois College of Medicine at Rockford. "Within this one implant, I get the bone ingrowth and mechanical strengths of the original HEALICOIL, as well as the bioabsorption advantages that come from gradually transferring the stresses to the healing bone as the anchor is steadily absorbed."
Most biocomposite implants utilize the osteoconductive properties of beta tricalcium phosphate (-TCP) to provide 18 months of sustained bone formation.[ii] While this is effective in creating a "scaffold" for enhancing new bone formation,[iii] REGENESORB goes one step further by adding a second osteoconductive component, calcium sulfate. Calcium sulfate has been shown to work in the early stages of bone healing and is associated with increased levels of local growth factors.[iv]
All HEALICOIL Suture Anchors use a unique, open-architecture design that eliminates the inner diameter material found in traditional, solid-core anchors. Pre-clinical testing has demonstrated that this design allows for new bone to fill the spaces between the threads and within the central channel by 12-weeks after implantation.[v] In addition, the extended, fully-threaded HEALICOIL REGENESORB anchor design was shown in biomechanical testing to provide more threaded engagement than other biocomposite anchors; delivering greater pullout strength in poor-quality, osteoporotic bone.[vi] Additionally, the HEALICOIL inserter engages nearly 100% of the anchor's length, which minimizes stress and provides predictable insertion into hard bone by distributing torque along the entire length of the anchor.[vii]
"When we introduced the HEALICOIL PK Suture Anchor, its design set a new standard for innovation in our industry," says Brad Cannon, President, Endoscopy, Trauma and Extremities for Smith & Nephew. "With HEALICOIL REGENESORB, we combined the benefits of that design with an advanced material to raise the standard even higher."
Designed primarily for shoulder rotator cuff repair, the HEALICOIL REGENESORB Suture Anchor is also indicated for use in the knee, elbow, foot and ankle.
Pre-clinical testing is based on laboratory research and not clinical testing on actual patients. Therefore, it is not necessarily indicative of actual clinical results. The biomechanical testing was conducted in 5pcf (pounds per cubic feet) bone block, a substance with a density equivalent to the worst-case, poorest-quality decorticated humeral bone.
The rotator cuff, which is made up of a group of four muscles whose tendons converge to help stabilize and move the shoulder, is subject to a considerable amount of wear and tear with regular daily activities especially repetitive overhead motions. Current Smith & Nephew estimates are that over 1 million rotator cuff procedures are performed on an annual basis globally to alleviate persistent pain and help patients regain a full range of motion.
About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma, Smith & Nephew has around 11,000 employees and a presence in more than 90 countries. Annual sales in 2012 were more than $4.1 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
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[i] 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 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
[ii] Costantino PD, Friedman CD. Synthetic Bone Graft Substitutes. Craniofacial Skeletal Augmentation and Replacement (1994) 27(5):1037-1074.
[iii] Ogose et al. Histological assessment in grafts of highly purified beta-tricalcium phosphate in human bones. Biomaterials (2006), 27(8): 15421549.
[iv] Walsh et al. Response of a Calcium Sulfate Bone Graft Substitute in a Confined Cancellous Defect. Clin. Orthop. and Rel. Res. (2003) 406:228-236.
[v] 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.
[vi] Report Number 15002036 HEALICOIL Suture Anchor competitive testing. Data on file. August 2013
[vii] Report Number 15002036 HEALICOIL Suture Anchor competitive testing. Data on file. August 2013
SOURCE Smith & Nephew