GRYPHON BR Suture Anchor

Transcription

1 GRYPHON BR Suture Anchor Key Features & Benefits GRYPHON T GRYPHON P GRYPHON BR is the newest and smallest shoulder instability anchor in the DePuy Mitek portfolio. This suture anchor, despite being small lives up to the other BR family of anchors in strength and material composition. Made with the #1 U.S. biocomposite material for shoulder and knee implants1 to create the next generation small instability anchor that will offer surgeons: 1. Optimized Material BIOCRYL RAPIDE a strong radiolucent TCP/PLGA composite 30% Osteoconductive Tricalcium Phosphate (TCP) and 70% faster resorbing PLGA 10.8mm Length 3.0mm Outer diameter 2. Optimized Strength 3. Optimized Anchor Choice (Thread-In or Push-In) 4. Optimized Suture Strength/Suture eyelet 2.5mm Minor diameter GRYPHON T * This design offers the strength of the BR material along with an internally driven threaded anchor for tactile feel1. Provides audible feedback and confidence of fixation Internally driven thread-in anchor design GRYPHON P * This design offers the strength of the BR material along with a barbed design for ease of insertion1. Over 50 lbs. of pull-out strength1 Compression fit offers tactile feel for insertion confidence Barbed design lends itself to easier insertion, push-in F O R I N T E R N A L U S E O N LY N O T F O R D I S T R I B U T I O N O R P U B L I C AT I O N 1 Based on U.S. data on file at DePuy Mitek. *Instrumentation includes a 3.1mm x 17.25mm Tap and a 2.4mm X 17.8mm Drill Bit

2 Feature Function Benefit Cannulated Anchor Provides a channel for blood flow Allows blood flow to the articular surface BR molding Allows for smooth BR anchor surface with minimized mold lines Stronger Anchor2 Offers 2 distinct designs (threaded and ribbed) Allows for choice in compression or thread in fit Optimal choice and pullout strength Full thread internally driven driver design GRYPHON T only Provides increased torque capabilities1 and compression fit Tactile feel and confidence during insertion Smooth distal suture bridge Provides excellent suture sliding and optimal abrasion resistance compared to Bio-Corkscrew FT* Reduces suture abrasion in rehab & knot tying Minimizes force on anchor fixation Slide-ability = simplified knot tying Strength with less stiffness than #2 Blue FiberWire* Better handling3 ORTHOCORD suture with PDS & UHMWP is 45% less stiff Side-by-Side Anchor Pull-Out 4 Average Load (lbs.) GRYPHON P BR Arthrex, Bio-SutureTak Arthrex, BioComposite SutureTak * FiberWire and Bio-Corkscrew FT are registered trademarks of Arthrex, Inc. 1 Compared with Corkscrew FT Suture Anchor by Arthrex, Inc., Naples, FL. 2 In comparison with Bio-SutureTak and BioComposite Suture Tak, registered trademarks of Arthrex, Inc. 3 In comparison with FiberWire Arthrex, Inc. 4 Data on file at DePuy Mitek. GRYPHON T BR Arthrex, Bio-Fast

3 GRYPHON BR Suture Anchor Surgical Technique Inserting GRYPHON P BR Inserting GRYPHON T BR 1) Use the GRYPHON sawtooth or fishmouth guide (with obturator) to find the anchor site for insertion. 1) Use the GRYPHON sawtooth or fishmouth guide (with obturator) to find the anchor site for insertion. 2) Remove the obturator, hold the guide firmly in place, drill with the GRYPHON 2.4mm drill bit until the drill collar meets the guide (bit bottoms out). 2) Remove the obturator, hold the guide firmly in place, drill with the GRYPHON 2.4mm drill bit until the drill collar meets the guide (bit bottoms out). Remove the drill bit from the guide. 3) Maintaining guide alignment, insert a GRYPHON P BR Anchor down the guide. Apply slight pressure to engage the anchor tip, and then begin to tap the back of the inserter to advance the anchor into the drill hole. Drive the anchor to the proper depth. 3) Maintain the guide in place, insert the GRYPHON Tap down the guide. Applying slight pressure, begin to turn the TAP and engage the Tap threads to advance the TAP into the drill hole. Continue to advance the Tap until the laser lines meet in the guide window OR, viewing outside the shoulder, the laser line on the proximal part of the Tap shaft meets the proximal end of the guide handle. Back the Tap out by rotating counter clockwise. 4) Proper depth of the anchor is established when the laser lines in the window meet OR viewing outside the shoulder, the laser line on the proximal part of the anchor inserter shaft meets the proximal end of the guide handle. 4) Maintaining guide alignment, insert a GRYPHON T BR Anchor down the guide. Apply slight pressure to engage the anchor tip, and then begin to rotate with pressure to engage the anchor threads and drive the anchor to the proper depth. 5) Before removing the inserter, slide the inserter handle door open, remove the suture card completely and discard, allowing the suture limbs to be free. 5) Proper depth of the anchor is established when the laser lines in the window meet OR viewing outside the shoulder, the laser line on the proximal part of the anchor inserter shaft meets the proximal end of the guide handle. 6) Remove inserter from anchor by pulling straight back on handle. 6) Before removing the inserter, slide the inserter handle door open, remove the suture card completely and discard, allowing the suture limbs to be free. 7) Remove inserter from anchor by pulling straight back on handle.

4 Positioning Against Competition Competition Arthrex Bio-SutureTak Sell AgainstSELL Info AGAINST INFO GRYPHON T offers an internally driven threaded anchor for tactile feel. Its pull-out strength is lbs. Arthrex Bio-FASTak Stryker Mainstay Zip Smith & Nephew TWINFIX TI Con Med Linvatec Bio Mini-Revo Smith & Nephew BIORAPTOR GRYPHON P offers a barbed design with ease of insertion and optimal strength. Its pull-out strength is lbs. Both GRYPHON P and GRYPHON T anchors can interface seamlessly with the IDEAL Suture Management Family of arthroscopic devices, together offering a comprehensive anchor and suture management package. BIOCRYL RAPIDE composite is exclusively developed by DePuy Mitek in association with Advanced Technologies and Regenerative Medicine, LLC. Developed for use when your procedure calls for the beneficial results of a bio-replaceable implant. BIOCRYL RAPIDE promotes optimized resorption and strength and has been proven in pre-clinical trials to resorb and be replaced with bone in 24 months1. DePuy Mitek anchors come preloaded with ORTHOCORD suture with a tensile strength of 55 lbs and a knot tensile strength of 30 lbs2. The permanent suture with a 62% PDS component has less mass postoperatively, resulting in a lower profile knot and a softer braid that maintains knot tensile strength when compared to FiberWire #22. Journal Resources: Suture Strength Comparison: American Journal of Sports Medicine Sept (Not available on Allied, just Spartacus) 1 Clinical data from Clinical Update: Imaging and in vivo Absorption of ß-TCP/PLGA Interference Screws Used in ACL Reconstruction. Barber, et al. DePuy Mitek White Paper, Data on file with DePuy Mitek

5 Selling Tactics Understand your customer needs. What are they using and why? Prefers Peek Sell Surgeons with Likes that Peek is inert. Doesn t trust absorbables, may have been burned by certain absorbables that have been recalled or seeing reports of PLA issues (osteolysis) Wants the best of both worlds. The strength of a metal but the radiolucency of a absorbable Resists abrasion Patient allergies Doesn t restore the natural anatomy If it pulls out, how do you know? Can t find the floating product on X-ray GRYPHON T BR (Thread-In) anchor offers an internally driven threaded anchor for tactile feel. Size and Flexibility: When the anchoring location is tight on space but the pull-out strength cant be compromised, call on the smaller sized anchor comprised of BIOCRYL RAPIDE. Prefers Absorbables Wants to restore the anatomy Radiolucent (nearly invisible) Likes reproducibility Appealing to patients Material strength Potential for patient reaction and allergies Prefers Metal Likes Strength Likes reproducibility They want to see it on X-Ray Meticulous and want to know if the anchor is out of place Easy: single step insertion Legacy: it s always worked for them Great for patients with allergies Likes that metal is inert or may not trust absorbables Radio-opacity and/or MRI scatter Revision difficulties Fear of pullout~ floating artifact Ease of Use: Some of the surgeons targeted may not object to a few extra steps, but when you combine the ease of use of the new GRYPHON anchors with its proven strength and small design they will convert! Who to Target 1 ST Targets: Target Surgeon Profile High Volume Surgeons who Prefer compression type anchor fixation Prefer smaller anchors and instrumentation Use products from the following companies: Arthrex BioComposite SutureTak Bio-SutureTak Stryker ConMed Linvatec Smith & Nephew Product Bridging Lost LUPINE Business or Business at Risk Target Profile Stuck in their ways but vulnerable to competitive threats Likes ORTHOCORD Recently switched from DePuy Mitek to competitor because of instrumentation 2 nd Targets: Target Surgeon Profile Long time loyalist to current anchor/co. You've been trying to crack the business for awhile and needed that 1 product Needs data wants strong products Prefers a thread-in anchor Use products from the following companies: Smith & Nephew ConMed Linvatec Stryker Your GRYPHON BR anchors can interface seamlessly with the IDEAL Suture Management Family of arthroscopic devices, together offering a comprehensive anchor and suture management package. The IDEAL Family delivers choice of method (retriever or shuttle), tip configurations, and actuation, all with technique versatility. It is a complete, disposable instrumentation system with innovative attributes designed to meet your arthroscopic suture management needs. DePuy Mitek, Inc All rights reserved. Printed in the USA.