SKILL, DEDICATION, AND

Transcription

1 SKILL, DEDICATION, AND TM This publication is not intended for distribution in the USA. PRODUCT BROCHURE

2 DELIVERING CONFIDENCE IN HIP ARTHROSCOPY The number of hip arthroscopy procedures performed in the five years since 2007 more than doubled 1 due to growing interest among surgeons in helping to preserve hip health and function within an increasingly aware and active patient population. Advances in technique and technology have evolved hip surgery from an open procedure to an arthroscopic procedure, and have increased the complexity of conditions that can be treated in the central and peripheral compartments as well as the peritrochanteric space. Innovation will undoubtedly continue to advance the treatment of patients with hip pain and injuries. Mitek Sports Medicine introduces the ENDURANCE TM Hip Platform, delivering excellence in arthroscopy to the hip. Whether you are new to hip arthroscopy or experienced in this anatomy, the ENDURANCE Hip Platform provides innovative products, and excellence in education and service for a comprehensive hip arthroscopy solution. With the ENDURANCE Hip Platform, you can focus with confidence on getting your patients back to their passion. 2 DePuy Synthes Mitek Sports Medicine ENDURANCE Hip Solutions

3 TABLE OF CONTENT ENDURANCE Hip Solutions Overview 4-5 Hip Access 6-7 GRYPHON Anchor Hip System 8-9 The Clear Canula System 10 Hip Procedure System 11 The VAPR VUE System with COOLPULSE Technology 12 FMS DUO + Fluid Management System 13 Hip in a Box 14 Ordering Information 15 ENDURANCE Hip Solutions DePuy Synthes Mitek Sports Medicine 3

4 ENDURANCE HIP SOLUTIONS OVERVIEW Hip Access Kit A comprehensive kit that enables confident entry into the hip Needles have a robust plastic hub and tip designed to provide sensitive control during insertion Nitinol guidewires provide the flexibility you need when entering the hip joint Hip Procedure System 190-mm working length Curves of varying angles: up, right, and left to reach difficult-to-access areas in the hip Tools for the standard procedure and for handling unexpected events GRYPHON Anchor with Hip Drill Guide Anchor available in both BIOCRYL RAPIDE Biocomposite Material and PEEK GRYPHON Hip Drill guide, offering extra working length for the hip ORTHOCORD High Strength Orthopaedic Suture with a absorbable polydioxanon (PDS ) component has less mass postoperatively 4 DePuy Synthes Mitek Sports Medicine ENDURANCE Hip Solutions

5 Clear Cannulas Disposable cannulas with disposable obturator (reusable obturator available) Available in both 90 mm and 110 mm. The 110-mm length offers access to the deeper hip joint while maintaining visibility of tools Combine with DePuy Synthes Mitek Sports Medicine FMS DUO+ Fluid Management System for optimal performance FMS DUO+ System Enables optimal visibility by managing both inflow and outflow Reduces risk of extravasation in hip arthroscopy through independent control of pressure and flow Simplifies setup and minimizes prep time for greater operating-room efficiency VAPR VUE RADIOFREQUENCY SYSTEM Proprietary COOLPULSE Technology, with unique power pulses, enables 20.4% faster ablation than the leading competitor at equal or lower heat levels 2 Smaller tip size and shaft diameter allow easy access to smaller spaces and greater maneuverability Minimal bubbles generated and clogging significantly minimized compared to leading competitor* *As compared to ARTHROCARE SUPER TURBOVAC during in vitro testing 2 ENDURANCE Hip Solutions DePuy Synthes Mitek Sports Medicine 5

6 HIP ACCESS Multiple Kits to meet the needs of every surgeon. Offering straight, curved or no blade options, the Hip Access Kit provides the components you need for optimal hip access. Multiple needle lengths enable portal placement in all patients 16-G nitinol guidewires provide both the flexibility needed inside the acetabulum and the rigidity necessary to maintain trajectory through soft tissues Round tip guidewires for less aggressive contact with the cartilage The nitinol guidewire is designed to work in seamless partnership with the Mitek Sports Medicine dilation system 6 DePuy Synthes Mitek Sports Medicine ENDURANCE Hip Solutions

7 Hip Straight Blade Sharp every time, allowing you to cut through even the thickest hip capsule 3 Designed to resist breaking when used for a hip capsulotomy 4 At 28 cm, the handle length is ideal for all patient sizes Blades also available separately Hip Curved Blade Designed with a 20 degree bend, to mimic the natural contours of the hip Offers all of the same features and benefits of the Hip Straight Blade Blades also available separately ENDURANCE Hip Solutions DePuy Synthes Mitek Sports Medicine 7

8 GRYPHON ANCHOR HIP SYSTEM GRYPHON Anchor Hip System Available in both BIOCRYL RAPIDE Biocomposite Material and PEEK GRYPHON Anchor Hip Drill guide, offering extra working length for the hip Single or double loaded with ORTHOCORD Suture ORTHOCORD Suture ORTHOCORD Suture is designed to help minimize the amount of suture and knot mass, which could potentially interfere with the labral function in a hip repair Partially (62% PD S) absorbable with a reduction of knot profile over time (The PDS component of ORTHOCORD Suture is essentially absorbed between 238 and 294 days post-implantation 5.) Smaller knot profile with high knot-retention force 8 8 DePuy Synthes Mitek Sports Medicine ENDURANCE Hip Solutions

9 BIOCRYL RAPIDE BIOCOMPOSITE MATERIAL BIOCRYL RAPIDE Biocomposite Material is a second-generation composite material consisting of 30% osteoconductive ß-TCP and 70% PLGA. A proprietary microparticle dispersion (MPD) manufacturing process ensures a homogenous dispersion of the composite materials, reducing the incidence of stress risers, and ensuring that osteoconductive ß-TCP is in close apposition with the surrounding bone tissues during the absorption process. 9 In long-term human CT imaging studies, BIOCRYL RAPIDE Biocomposite Material appears to be absorbed with observed bony replacement by 36 months. 10,11 Long-term CT Images of PLLA vs MILAGRO BR (ß-TCP/PLGA) Interference Screws 11 PLLA Image taken ~7 years post-op Screw appears fully absorbed No observed bony replacement in screw profile ß-TCP/PLGA Image taken ~3 years post-op Screw appears fully absorbed Bony replacement in screw profile 11 ENDURANCE Hip Solutions DePuy Synthes Mitek Sports Medicine 9

10 THE CLEAR CANNULA SYSTEM The Clear Cannula System: Your Clear Choice Disposable cannula with both disposable and reusable obturator available Available in both 90 mm and 110 mm; the 110-mm length offers access to the deeper hip joint while maintaining visibility Combine with DePuy Synthes Mitek Sports Medicine FMS DUO+ Fluid Management System for optimal performance Triple-Seal Dam Provides fluid retention with minimal leakage key in arthroscopy Allows easy passage of suture and instruments The first step in fluid management in your arthroscopic hip procedures 10 DePuy Synthes Mitek Sports Medicine ENDURANCE Hip Solutions

11 HIP PROCEDURE SYSTEM The DePuy Synthes Mitek Sports Medicine Hip Procedure System is an extensive offering of precision instruments that have been designed for hip arthroscopy. This wide range of tools puts the appropriate solutions in your hands every step of the way with hip-joint access and tissue and suture management solutions and much more. The Hip Procedure System brings you optimal ergonomics and tip designs along with: 190-mm working length Curves of varying angles: up, right, and left to reach the hard-to-access areas in the hip Tools for the standard procedure as well as unexpected moments The Hip Procedure System is delivered in its own tray, designed in partnership with OR personnel to ensure optimized procedural flow. The tray also provides for a convenient central location for additional instruments. 5.5 and 6.0 Hip Slotted Cannula Hip Suture Manipulator Hip Biter Straight and 15º Up Hip Grasper 20º Right, 20º Left, and Straight 4.0, 4.5, 5.0, 5.5, and 6.0 Hip Cannulated SwitchStick Handle, Hip SwitchStick Hip Suture Passer, Straight and 15º Up Hip CordCutter Hip Knot Manipulator Hip Curette, 20º Hip TissLib Blade, 20º Down Hip Probe, 90º ENDURANCE Hip Solutions DePuy Synthes Mitek Sports Medicine 11

12 THE VAPR VUE SYSTEM WITH COOLPULSE TECHNOLOGY The VAPR VUE System with COOLPULSE Technology is the next-generation radiofrequency system that provides clear and sustained visibility, enhanced procedural efficiency, and exceptional flexibility. Proprietary COOLPULSE Technology provides quicker tissue ablation while generating equal or less heat.* Features and Benefits Unique power pulses enable faster and more rapid ablation while generating equal or less heat Targeted ablation minimizes risk of accidental damage to healthy tissue Easy and quick adjustment of ablation and coagulation settings over a wide power range to optimize probe performance based on anatomical considerations *As compared to ARTHROCARE SUPER TURBOVAC during in vitro testing 2 12 DePuy Synthes Mitek Sports Medicine ENDURANCE Hip Solutions

13 FMS DUO+ FLUID MANAGEMENT SYSTEM The FMS DUO+ System lets you focus on your patient and the procedure not on operating the pump. Complications from extravasation in hip arthroscopy are well documented. 6,7 With FMS DUO+ System, you re in control when conditions change, allowing you to adjust pressure or flow at a moment s notice with a clear field of vision. Enables optimal visibility by managing both inflow and outflow, and delivering smooth, continuous flow Controls pressure and flow to address extravasation concerns in hip arthroscopy Simplifies setup and minimizes prep time for greater operating-room efficiency Features and Benefits Controls pressure and flow independently for extravasation prevention Red pedal pressure control to bleeding Blue pedal flow control to clear debris without increasing pressure Enhances operating room efficiencies by helping to shorten procedure times, decrease patient traction time, and lower costs ENDURANCE Hip Solutions DePuy Synthes Mitek Sports Medicine 13

14 HIP IN A BOX The Hip in a Box training model is an advanced training tool designed to provide tactile feedback and allow surgeons to practice: Portal placement Joint access Labral repair Training components The Hip in a Box training model consists of a base, a replaceable hip joint, and a replacement skin (either transparent or opaque) that fits over the joint. Benefits Replicates patient set up, allowing for hip joint distraction and femur rotation The radio-opaque design allows for use with a C-arm The clear skin aids in viewing the trajectory into the joint Hip in a Box is an ideal demonstration tool for educating residents, fellows, as well as patients 14 DePuy Synthes Mitek Sports Medicine ENDURANCE Hip Solutions

15 ORDERING INFORMATION Hip Access Product Code Product Name Quantity Unit Hip Blade Curved 1 Each Hip Blade Straight 1 Each Hip Access Kit No Blade 1 Box Hip Needle 16G x 6 Hip Needle 16G x 7 2 Guidewires 0.49 x 17.5 Surgical Marker Surgical Ruler Syringe 30 ml Hip Access Kit Curved Blade 1 Box Hip Access Kit Straight Blade 1 Box GRYPHON Family GRYPHON Hip Guide, Sawtooth 1 Each GRYPHON Hip Guide, Fishmouth 1 Each GRYPHON T BR Anchor w/orthocord 1 Each GRYPHON T BR DS Anchor w/orthocord 1 Each GRYPHON P BR Anchor w/orthocord 1 Each GRYPHON P BR DS Anchor w/orthocord 1 Each GRYPHON PEEK Anchor w/orthocord 1 Each GRYPHON PEEK DS Anchor w/orthocord 1 Each GRYPHON Obturator 1 Box GRYPHON Drill Bit 1 Box GRYPHON Tap 1 Box GRYPHON Blunt Obturator 1 Box Cannulas Threaded 5.5 x 90 mm 5 Box Threaded 8.5 x 90 mm 5 Box Partially Threaded 7 x 110 mm 5 Box x 90 mm Reusable Obturator 1 Each x 90 mm Reusable Obturator 1 Each x 110 mm Reusable Obturator 1 Each Hip Procedure System Hip Procedure System and Instruments 1 Set Hip-Slotted Cannula 1 Each Hip-Slotted Cannula 1 Each Hip Biter Straight 1 Each Hip Biter 15 Up 1 Each Hip Grasper 20 Right 1 Each Hip Grasper 20 Left 1 Each Hip Grasper Straight 1 Each Hip Suture Passer Straight 1 Each Hip Suture Passer Up 1 Each Hip Suture Manipulator 1 Each Hip CordCutter 1 Each Hip Knot Manipulator 1 Each Hip Curette 20 1 Each Hip TissLib Blade 20 down 1 Each Hip Probe 90 1 Each Hip Cannulated SwitchStick 1 Each Hip Procedure System (cont.) Hip Cannulated SwitchStick 1 Each Hip Cannulated SwitchStick 1 Each Hip Cannulated SwitchStick 1 Each Hip Cannulated SwitchStick 1 Each Handle, Hip SwitchStick 1 Each Sterilization Tray Hip Procedure System 1 Set Hip Sterilization Case 1 Each Lid, Hip Sterilization Case 1 Each Hip Entry and Tissue Removal Tray 1 Each Hip Slotted Cannula Tray 1 Each Hip Tissue and Suture Management Tray 1 Each Hip Labral Repair Tray 1 Each Hip Entry Tray Pin Mat Accessory 1 Each VAPR System COOLPULSE 90 Electrode 1 Each COOLPULSE 90 (with hand controls) Electrode 1 Each Premiere 90 1 Each S90 1 Each S90 (with hand controls) 1 Each Premiere 50 1 Each Premiere 50 (with hand controls) 1 Each S50 1 Each VAPR System 3 1 Each VAPR VUE System Generator 1 Each VAPR VUE System Wireless Footswitch 1 Each VAPR System Wired Footswitch 1 Each VAPR System Power Cord 1 Each FMS FMS DUO+ System 1 Each FMS DUO+ 2-Way Foot Pedal-Board 1 Each FMS SOLO Irrigation Pump 1 Each FMS SOLO 1-Way Foot Pedal-Board 1 Each InFlow Tubing FMS DUO+/FMS SOLO System 24 Pak Outflow Tubing without One-Way Valve 24 Pak Outflow Tubing with One-Way Valve (Reusable Setup) 24 Pak Intermediary Tubing without One-Way Valve 24 Pak Intermediary Tubing with One-Way Valve (Reusable Setup) 24 Pak Hip in a Box Training Model* HIAB Model (1 clear skin + 1 joint) 1 Each HIAB Clear Skin Replacement 1 Each HIAB Opaque Skin Replacement 1 Each HIAB Joint Replacement 1 Each *This is a training model. This is not for human use. ENDURANCE Hip Solutions DePuy Synthes Mitek Sports Medicine 15

16 References 1. U.S. Market for Orthopedic Soft Tissue Repair and Sports Medicine. idata Research Inc Oslan A, Martini N, Barry D, Tissington B. Comparative study of in vitro ablation rate and temperature increases for arthroscopic radiofrequency probes. Mitek Sports Medicine, Inc. white paper Weidner J, Büchler L, Beck M. Hip capsule dimensions in patients with femoroacetabular impingement: a pilot study. Clin Orthop Relat Res. 2012;470(12): Grant Bethany, Bhattacharyya SK, Ginggen LF, Mafilios MS, Busconi BD. Biomechanical evaluation of high performance blades used in hip arthroscopy Clinical Orthopaedic Society Annual Meeting 2013, Buffalo NY. 5. Data obtained from implantation studies in rats. Data on file. Mitek Sports Medicine. 6. Verma M, Sekiya JK. Intrathoracic fluid extravasation after hip arthroscopy. Arthroscopy. 2010;26(9 Suppl):S Sampson TG. Complications of hip arthroscopy. Clin Sports Med. 2001;20(4): Ilahi OA, Younas SA, Ho DM, Noble PC. Security of knots tied with ethibond, fiberwire, ORTHOCORD Suture, or ultrabraid. Am J Sports Med. 2008;36(12): Suchenski M, McCarthy MB, Chowaniec D, Hansen D, et al. Material properties and composition of soft tissue fixation. Arthroscopy. 2010;26(6): Barber FA, Dockery WD, Hrnack SA. Long-term degradation of a poly-lactide co-glycolide/ß-tricalcium phosphate biocomposite interference screw. Arthroscopy. 2011;27(5): Barber FA, Hurley JA. Clinical Update: imagining and in vivo absorption of ß-TCP/PLGA interference screws used in ACL reconstruction. Mitek Sports Medicine, Inc. white paper Limited Warranty and Disclaimer: DePuy Mitek, Inc. products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. Not all products are currently available in all markets. Third party trademarks used herein are trademarks of their respective owners. This publication is not intended for distribution in USA. Johnson & Johnson Medical Ltd. Pinewood Campus Nine Mile Ride Wokingham, Berkshire England RG40 3EW United Kingdom DePuy International Ltd. St. Anthony s Road Beeston Leeds West Yorkshire LS11 8DT United Kingdom Tel: +44 (0) Fax: +44 (0) DePuy Mitek, Inc. 325 Paramount Dr. Raynham, MA USA Tel: +1 (800) MEDNET GmbH Borkstrasse 10, Muenster, Germany 0086 T.A.G. Medical Products Corporation LTD. Kibbutz Gaaton Israel depuysynthes.com DePuy Synthes Mitek Sports Medicine, a division of DOI All rights reserved. CA#12885B Issued: 03/14