Feature Function Surgeon/Patient Benefit

Transcription

1 HEALIX BR Feature Function Surgeon/Patient Benefit 1. Optimized Material, the HEALIX BR anchor is the only Rotator Cuff anchor in the industry that contains BIOCRYL RAPIDE, which has 5 years of successful history with knee and shoulder implants 1, 2. BIOCRYL RAPIDE Material BR (TCP/PLGA) Resorbable MPD Technology (Micro Particle disbursement) Ceramic Bioresorbable Improved absorption profile Not visible on radiographs after TCP is absorbed Homogenous blend of PLGA and TCP particles minimizes clumping which cause stress risers Secure interface with bone Restores natural anatomy Doesn't absorb too fast or too slow Shadow visible for post op x-ray, but then goes away over time OPTIMAL STRENGTH! Squeaks provide audible feedback to the surgeons as well as tactile 2. Optimized Anchor Design HEALIX BR design gives surgeons the confidence to place a strong absorbable threaded anchor of appropriate size where they want on the tuberosity. It Squeaks upon insertion like MILAGRO BR, which provides audible feedback and confidence of fixation. Cannulated Anchor BR molding Full thread internally driven driver design Sizes: 4.5, 5.5, 6.5mm & Needle versions Provides a channel for blood flow Allows for smooth BR anchor surface with minimized mold lines Provides increased torque capabilities 3 Breadth Allows blood flow to the RC surface Stronger Anchor Insertion confidence Provides versatile options 1 In a long-term controlled study, BIOCRYL RAPIDE and PLA materials were evaluated in the cortical femoral bone of Beagles. Data on file at DePuy Mitek. 2 Clinical Update: Imaging and in vivo Absorption of ß-TCP/PLGA Interference Screws Used in ACL Reconstruction. Barber, et al. DePuy Mitek White Paper, Compared with SPIRALOK Anchor.

2 Feature Function Surgeon/Patient Benefit 3. Optimized Thread Design Increased number of threads provide improved bone contact, purchase & bite, while the dual threaded design independently engages both cortical & cancellous bone giving a secure hold in bone. Cancellous Threads Cortical Threads 10 Threads (5 Cortical, 5 cancellous) Bone specific (cortical & cancellous) threads Tactile feedback during transition from cancellous to cortical threads Improved bone (cortical & cancellous) contact, purchase & bite 1 Dual Threaded design independently engages both cortical & cancellous bone Confirms anchor engagement and security Confidence of a secure fixation Maximizes fixation in bone by engaging bones differently Surgeon confidence in security of fixation 4. Suture eyelet & Suture Strength BR has a wider nose BR VS. Peek Peek is a stronger material and has a thinner nose Smooth distal suture bridge ORTHOCORD suture with PDS and UHMWP is 45% less stiff Provides excellent suture sliding and superior abrasion resistance compared to Bio-Corkscrew FT *2 Strength with less stiffness than competition as ORTHOCORD violet suture is 45% less stiff than #2 blue FiberWire* 1 Reduces suture abrasion in rehab & knot tying Minimize force on anchor fixation Slidability~easier to tie knots Better handling * FiberWire and Bio-Corkscrew FT are registered trademark of Arthrex, Inc. 1 As compared to 5.0 Spiralok, a trademark of DePuy Mitek, Inc. 2 Based on U.S. data on file at DePuy Mitek.

3 HEALIX Anchor Instrument Dimensions 4.5 Awl Width: 4.8mm 4.5 Cortical Awl/Tap Width: Inner ~3mm Outer ~4.4 5mm 5.5 Awl/Tap Width: Inner ~3.8 6mm Outer ~5.4 6mm 5.5 Cortical Awl/Tap Width: Inner ~3.8 6mm Outer ~5.4 6mm 6.5 Awl/Tap Width: Inner ~3.8 6mm Outer ~6.4 5mm

4 Material Material BIOCRYL RAPIDE a strong radiolucent TCP/PLGA composite (30% Osteoconductive Tricalcium Phosphate (TCP) and 70% faster resorbing PLGA Design Internally driven design Dual threaded (5 cortical/ 5 cancellous) Distal suture bridge eyelet H E A L I X B R B O N E S T O C K Q U A L I T Y Size Soft Medium Hard 4.5mm 6.5mm Awl Awl Awl 4.5mm Cortical Awl/Tap Cortical Awl/Tap 6.5mm Awl/Tap 4.5mm Cortical Awl/Tap Awl/Tap N/A no need for 6.5mm anchor in hard bone Understanding the Materials* PLGA -Looks Good! Product HEALIX BR Doubleplay** Biocomposite FT*** Manufacturer DePuy Mitek ArthroCare (Biocomposites Ltd.) Arthrex, Inc Overall Composition (by weight) 30% TCP 70% PLGA BIOCRYL RAPIDE 25% 75% PLLA 30% 70% PLLA Ceramic or 0steo-filler TCP = Beta-TriCalcium Phosphate TCP = Beta-TriCalcium Phosphate TCP = Beta-TriCalcium Phosphate Polymer or Co-polymer PLGA = Poly (L-lactic-co-glycolic) acid PLGA = 85% PLLA + 15% PGA PLLA Poly (L-lactic) acid Similar composition to DePuy Mitek s old BIOCRYL screw from 7 years ago PLLA Poly (L-lactic) acid Similar composition to DePuy Mitek s old BIOCRYL screw from 7 years ago *Data from competitive marketing materials and peer reviewed literature. ** Doubleplay is a trademark of ArthroCare Co. *** Biocomposite FT is a trademark of Arthrex, Co.

5 HEALIX Anchor Data Suture Abrasion Resistance 1 The HEALIX BR Dual Threaded Suture anchor and the Bio-Corkscrew FT * have a single suture attachment (suture bar & suture loop respectively) for all sutures The sutures on the HEALIX BR did not fail at 1500 cycles The sutures on the HEALIX PEEK 3-suture anchor performed 18% better on average than the Bio-corkscrew with two sutures in the suture abrasion test HEALIX PEEK Cycles to Suture Failure HEALIX BR HEALIX Ti Bio-Corkscrew FT 1 Data on file at DePuy Mitek, Inc., Raynham, MA 09/08 * Bio-Corkscrew FT is a trademark of Arthrex, Inc.

6 Surgical Technique HEALIX BR Proper Insertion: In soft bone only the awl needs to be used with HEALIX BR. Mallet the awl to the appropriate laser line. The 1st laser line is for the 4.5mm HEALIX. The second laser line is for 5.5/6.5mm HEALIX. Important: Insert the HEALIX BR in the same angle as the awl to insure proper anchor placement. The HEALIX should be fully inserted to the laser line directly proximal to the anchor. In hard bone use the appropriate size awl/tap combo to tap the bone. Insertion Angle: Laser line on anchor assumes that anchor will be inserted slightly off perpendicular. At 80 Insertion, Implant will be completely sub-cortical at driver laser line. Improper Insertion: Do not insert the HEALIX in a different angle than the bone was awled or tapped. In addition, HEALIX anchors should not be cantilevered into place. Either of these situations can cause damage to the anchor. Do not under awl the pilot hole for HEALIX. The awl must be inserted completely to the appropriate laser line. NOTE: Inserting the awl less than the specified depth, axial misalignment or levering with the anchor upon insertion, may result in anchor fracture.

7 Statistics for Competition Comparison DePuy Mitek HEALIX BR with ORTHOCORD BIOCRYL RAPIDE material (30% TCP/70% PLGA) FEATURES 1 Full thread internally driven driver design BENEFITS Insertion confidence 4.5mm 6.5mm 10 Threads (5 Cortical, 5 Cancellous) Confidence of a secure fixation in both cancellous and cortical bone to allow a strong fixation throughout the healing and rehab process TESTING / DATA Side by side cadaver - 67 lbs. Dual Threaded design - bone specific (cortical & cancellous) threads Tactile feedback during transition from cancellous to cortical threads Maximizes fixation in bone by engaging bones separately Surgeon confidence in security of fixation Smooth distal suture bridge Reduces suture abrasion in rehab & knot tying Minimize force on anchor fixation Slidability easier to tie knots Double loaded 4.5, 5.5, & 6.5 anchors Flexibility in accomplishing restoration of the natural footprint Potentially stronger repair due to multiple fixation points ORTHOCORD suture has 55 lbs. of tensile strength and is 45% less stiff Strong Lower profile over time Less Stiff 1 When compared to FiberWire, which is a registered trademark of Arthrex, Inc. Data on file with DePuy Mitek, Inc.

8 Positioning Against Competition Arthrex Bio-Corkscrew / FiberWire 1 Sell SELL Against AGAINST Info INFO Absorbable PLLA 2 or 3 Sutures 3.7mm x 17.9mm 5.0mm x 17.9mm 6.5mm x 17.9mm The HEALIX BR anchor has a dual thread design that independently engages both cortical and cancellous bone that maximizes fixation vs. the Bio-Corkscrew, which has a uniform thread pitch for cancellous engagement only. Bio-Corkscrew Eyelet sits above the level of the cortex. Bio-Corkscrew is made of PLDLA, which resorbs too quickly and allows the suture eyelet to come loose. ORTHOCORD suture loaded on our DePuy Mitek anchors. ORTHOCORD vs. FiberWire: 45% less stiff in your surgeons hands. With 55 lbs. of tensile strength and 30 lbs. of knot tensile strength, ORTHOCORD is more than strong enough. This permanent Suture with PDS component has less mass postoperativity. PDS component (62%) Softer braid provides better handling. PDS Component allows softer braid (lower profile knots). Ultra High Molecular Weight Polyethylene (38%) half the amount of Polyethylene than competition. Because ORTHOCORD is 45% less stiff, it provides better handling. 1 FiberWire and Bio-Corkscrew FT are registered trademarks of Arthrex, Inc. Linvatec ThRevo * & SuperRevo / HiFi * Sell SELL Against AGAINST Info INFO Titanium SuperRevo*- 2 sutures ThRevo* - 3 sutures 5.0mm The HEALIX anchor has a dual thread design that independently engages both cortical and cancellous bone to maximize fixation, whereas Linvatec s ThRevo has only a uniform thread pitch. Difficult to start ThRevo anchor in bone because stout distal tip is too large. Small suture bar allows sutures to get bound up. ORTHOCORD sutures are loaded on our DePuy Mitek anchors. ORTHOCORD is less abrasive than 100% polyethelene suture Linvatec's Herculine Suture. PDS component (62%) Softer braid provides better handling. PDS Component allows softer braid (Lower Profile Knots). Ultra High Molecular Weight Polyethelene (38%). Half the amount of Polyethelene than Competition.45% less stiff provides for better handling because suture is less stiff. Softer suture may reduce the suture tissue cut through. * ThRevo, SUPEREVO, & Force Fiber are trademarks of Linvatec

9 Positioning Against Competition Arthrotek ALLthread * PEEK & Titanium / Maxbraid * Sell SELL Against AGAINST Info INFO Non-absorbable Titanium 2 or 3 Sutures ALLthread has a uniform thread pitch for cancellous engagement only and requires good cortical bone for the 1-2 cortical threads to hold on. (See additional info in first Sell Against Info.) Titanium, 6.5mm PEEK, 6.8mm * ALLthread and Maxbraid are trademarks of Arthrotek, Inc. Stryker BioZip/ Force Fiber ** Sell Against Info Bio-Absorbable PLLA Fully Threaded countersunk FiberWire eyelet 5.0mm 6.5mm The BioZip s eyelets are likely to fail with less cyclic loading due to the minimal amount of absorbable PLLA forming the eyelet. For arthroscopic repair, the BioZip s needles must be cut off. Despite the cannulated trocar, the BioZip has been known to break on insertion without a predrilled hole. The BioZip is not truly fully threaded due to the placement of its eyelets at the proximal portion of the anchor. (See additional info in first Sell Against Info.) **Stryker BioZip and Force Fiber are trademarks of Stryker.

10 Positioning Against Competition S&N Twinfix * / Ultrabraid * Sell SELL Against AGAINST Info INFO Threaded, titanium anchor with 2 sutures 5.0mm 6.5mm The Twinfix has the HiLo thread which outer thread made reduce performance of minor threads. Suture eyelets are not perpendicular and are deep within anchor, which could cause sutures to bind. Long proximal anchor neck may sit proud if anchor sets proud. (See additional info in first Sell Against Info.) * Twinfix & Ultrabraid are trademarks of Smith & Nephew, Inc. S&N Twinfix AB * / Ultrabraid ** Sell Against Info Bio-Absorbable Suture Anchor PLLA 5.0mm 6.5mm Twinfix AB has a uniform thread pitch for cancellous engagement only. Suture eyelets are not perpendicular and are deep within anchor, which could cause sutures to bind. Long proximal anchor neck may sit proud if anchor sets proud. (See additional info in first Sell Against Info.) * Twinfix and Ultrabraid are trademarks of Smith & Nephew, Inc.

11 Commonly Asked Questions Q:How long is the Awl? A: The Awl from distal tip to the 4.5 laser line is 22mm in length. The Awl from distal tip to the 5.5/6.5 laser line is 29mm in length. Q: Do I have to use an Awl/Tap for HEALIX BR? A: Yes, for medium or harder bone. For soft bone stock it may not be necessary. Your surgeon can use the new cortical Awl/Tap, which has less turns or the full Awl/Tap combo and then insert the anchor or use the Awl in combination. It is not necessary to use the Awl before the awl/tap combo; it is more a matter of surgeon preference than performance. Q: Does the Awl need to go to the appropriate laser line, i.e. 4.5mm laser line for HEALIX 4.5 and 5.5/6.5mm laser line for HEALIX 5.5 and HEALIX 6.5? A: Yes, cheat on Awling increases the force to insert anchors and can cause breakage of the anchors. It is very important to instruct your surgeon on the proper insertion steps for HEALIX to ensure maximum performance. Q: What happens if you bury the anchor s head past the cortical surface? A: HEALIX was designed on dual thread technology and relies on cortical and cancellous fixation. When the anchor is buried past the cortical bone, the cortical fixation is lost and the probably of anchor pullout may increase. Ensure that surgeons use proper technique. In additional, in hard bone the 4.5 anchor may not have proper clearance, which may result in suture binding or anchor fracture. Q: What happens if the HEALIX Anchor breaks upon insertion? A: Your surgeon should try to understand what the root cause of the failure is; i.e. under tapping, levering, dense hard bone that wasn t tapped, insertion angle differs from awled angle, etc. This will be a good learning point going forward. As far as what to do intraoperatively, your surgeon should judge whether they have good fixation and the sutures slide. Pearl few instances where the fractured part of the anchor was mid body. It was removed and the cases were successfully completed with the anchor in place because the fixation was so solid and the sutures were unaffected. If this is not the case all parts of the anchor should be safely removed before proceeding. Q: What if the anchor pulls out intraoperatively? A: Your surgeon should evaluate the reason for the anchor s pullout; i.e. bone quality, technique. All of these can negatively impact the performance of HEALIX. Your surgeon may be able to salvage the hole by placing a larger anchor such as a 6.5 HEALIX after a pullout or a after a 4.5mm pullout. A SPIRALOK 6.5mm, FASTIN RC 6.5mm, or PANALOK RC can also be used. Q: At what angle should the HEALIX Anchor be inserted? A: Typically first generation anchors relied on cancellous fixation and a 45 dead man s angle was recommended. It s not necessary to go quite to a 45 angle as you re not relying on the anchor to act as a tent stake. Any angle from 90 to 45 will work fine. Note: however, the more of an angle from cortical layer selected the deeper the anchor has to be inserted so that it is subcortical on all sides. In such a case with the 4.5 anchor a slight additional Awling is probably necessary. Q: How far apart should the anchors be placed? A: At least 5mm, in average bone stock. In weaker bone, anchors should be placed slightly further apart as HEALIX relies on solid cortical fixation for part of its strength. Journal Resources * TCP/PLLA Implant Journal Summary: Long Term Absorption of ß-Tri-Calcium Phosphate Poly-L-Lactic Acid Interference Screws Barber, F, Dockery, W. Arthroscopy Vol. 24 Issue 4, April Purpose: Adding Beta-TriCalcium Phosphate has been shown to promote bony in-growth! Full article also available on Spartacus The Mattress-Tension-Band (MTB) Technique: A Knotless Double-Row Arthroscopic Rotator Cuff Repair. Pascal Boileau, M.D. et al. Shoulder Concepts 2008 Arthroscopy and Arthroplasty pp 245. May 2008