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HEALIX TRANSTEND IMPLANT SYSTEM DS (DUAL SUTURE) PARTIAL TEAR. COMPLETE SOLUTION. A percutaneous solution for partial tears of the rotator cuff. This publication is not intended for distribution in the USA. DUAL SUTURE
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Page 1: HEALIX TRANSTEND IMPLANT SYSTEM DSsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...HEALIX TRANSTEND Implant System DS Mitek Sports Medicine 3 Dual-thread technology Cannulation

HEALIX TRANSTEND™ IMPLANT SYSTEM DS(DUAL SUTURE)

PARTIAL TEAR. COMPLETE SOLUTION.

A percutaneous solution for partial tears of the rotator cuff.

This publication is not intended for distribution in the USA.

DUAL SUTURE

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2 Mitek Sports Medicine HEALIX TRANSTEND Implant System DS

HEALIX TRANSTEND Anchors

• 3.4 mm BR anchor

• 3.4 mm PEEK anchor

• 2.9 mm Ti anchor (available only as single loaded)

The HEALIX TRANSTEND Implant System DS is available in 1 or 2 anchor kits. Each kit includes:

• 1 or 2 Dual Suture BIOCRYL® RAPIDE™ Biocomposite Material (BR), PEEK, orSingle Suture Titanium (Ti) HEALIX TRANSTEND Anchor(s)

• PERCANNULA System (cannula, obturator and guidewire)

THE COMPREHENSIVE PROCEDURAL SOLUTION

PERCANNULA System

• 4.0 mm cannula

• Cannulated obturator

• 1.1 mm guidewire

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HEALIX TRANSTEND Implant System DS Mitek Sports Medicine 3

Dual-thread technology

Cannulation channels blood to the surface

Laser markings represent suture eyelet orientation

908070605040302010

0

Anchor Pull-Out Strength*

Ave

rage

Loa

d (lb

s)

HEALIX TRANSTEND BR

HEALIX TRANSTENDTi

HEALIX TRANSTEND PEEK

The HEALIX TRANSTEND Anchor features:

Strength• Cortical and cancellous threads• 2 strands of ORTHOCORD®

High-Strength Orthopaedic Suture – 55 lbs of tensile strength* – 45% less stiff than FibreWire*

Materials• BIOCRYL RAPIDE (biocomposite) • PEEK • Titanium

Precision• Delivery system minimizes

trauma to surrounding tissue• Double loaded for multiple

repair constructs• Small diameter allows for

exact placement

* DVE-041100P, DVE-001861-DVR, DVE-001794-DVR, DVE-001899-DVR and data on file DHF at 2002-38 stiff

FEATURES AND BENEFITS: HEALIX TRANSTEND ANCHORS

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CA #12512A

Hindawi Publishing CorporationAdvances in OrthopedicsVolume 2012, Article ID 798521, 6 pagesdoi:10.1155/2012/798521

Research Article

Comparison of the Tendon Damage Caused by Four DifferentAnchor Systems Used in Transtendon Rotator Cuff Repair

Qing-Song Zhang,1, 2, 3 Sen Liu,1, 2 Qiuyang Zhang,1 Yun Xue,1 Dongxia Ge,1

Michael J. O’Brien,2 Felix H. Savoie,2 and Zongbing You1, 2

1 Department of Structural and Cellular Biology, and Tulane Cancer Center, LCRC, Tulane Center for Aging, Tulane Center forStem Cell Research and Regenerative Medicine, Tulane University School of Medicine, New Orleans, LA 70112, USA

2 Department of Orthopaedic Surgery and Tulane Institute of Sports Medicine, Tulane University School of Medicine, New Orleans,LA 70112, USA

3 Department of Orthopaedic Surgery, Pu Ai Hospital of Tongji Medical College, Huazhong University of Science and Technology,Wuhan 430033, China

Correspondence should be addressed to Zongbing You, [email protected]

Received 12 December 2011; Revised 15 April 2012; Accepted 1 May 2012

Academic Editor: Virak Tan

Copyright © 2012 Qing-Song Zhang et al. This is an open access article distributed under the Creative Commons AttributionLicense, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properlycited.

Objectives. The objective of this study was to compare the damage to the rotator cuff tendons caused by four different anchorsystems. Methods. 20 cadaveric human shoulder joints were used for transtendon insertion of four anchor systems. The Healix Peek,Fastin RC, Bio-Corkscrew Suture, and Healix Transtend anchors were inserted through the tendons using standard transtendonprocedures. The areas of tendon damage were measured. Results. The areas of tendon damage (mean± standard deviation, n = 7)were 29.1± 4.3 mm2 for the Healix Peek anchor, 20.4± 2.3 mm2 for the Fastin RC anchor, 23.4± 1.2 mm2 for the Bio-CorkscrewSuture anchor, 13.7± 3.2 mm2 for the Healix Transtend anchor inserted directly, and 9.1 ± 2.1 mm2 for the Healix Transtendanchor inserted through the Percannula system (P < 0.001 or P < 0.001, compared to other anchors). Conclusions. In a cadavertranstendon rotator cuff repair model, smaller anchors caused less damage to the tendon tissues. The Healix Transtend implantsystem caused the least damage to the tendon tissues. Our findings suggest that smaller anchors should be considered whenperforming transtendon procedures to repair partial rotator cuff tears.

1. Introduction

The rotator cuff of the shoulder joint is made up of fourmuscles (the supraspinatus, infraspinatus, subscapularis, andteres minor) and their tendons. Its function is to lift androtate the arm and to stabilize the humeral head againstthe glenoid. Partial-thickness rotator cuff tears (PRCTs) area common component of rotator cuff disease, bridging thegap from tendinitis to frank tendon disruption. PRCT hasbeen divided into three types based on its location, includingbursal surface, articular surface, and intratendinous tears[1, 2]. Histological studies have shown that anatomicaldifferences make the articular portion of the rotator cufftendons more vulnerable to tension [3–5]. Snyder andcolleagues used the term PASTA to represent partial articular

supraspinatus tendon avulsion [6, 7]. PASTA has a highlikelihood of progression to complete tears in patients whoare not repaired timely, leading to consistent pain anddisability of the shoulder [6, 7].

Arthroscopic surgery is indicated in the patients whosePRCT has failed conservative treatments [8]. Two commonsurgical treatments include debridement of the tear with orwithout acromioplasty, or converting the PRCT into a com-plete tear and then repairing the tendon onto the humeralfootprint. The disadvantage of this second treatment optionis that the intact portion of the tendon is cut, and itmay potentially create a length-tension mismatch in therepaired rotator cuff [9, 10]. In order to preserve the intactportion of the tendon, the transtendon repair technique hasbeen developed [10]. In the transtendon procedure, a small

4 Mitek Sports Medicine HEALIX TRANSTEND Implant System DS

Peer reviewed publication showing that in cadaveric studies, “The HEALIX TRANSTEND Implant System (consisting of the HEALIX TRANSTEND Anchor and PERCANNULA System) among the anchors tested caused the least damage to the tendon tissue.”1

• Under the microscope The PERCANNULA System provides slight tissue compression and little to no “tendon fragmentation”

• The 4.0 mm PERCANNULA outer diameter minimizes trauma to the tendon vs. other anchor repair options

PROCEDURALLY REDUCING TENDON TRAUMA

Microscopic image of the impact caused by HEALIX TRANSTEND with the use of a PERCANNULA System

HEALIX PEEK FASTIN RC Bio-Corkscrew HTT with PERCANNULA

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1 2 3

1 2 3

HEALIX TRANSTEND Implant System DS Mitek Sports Medicine 5

SINGLE-ANCHOR DUAL-LOADED REPAIR CONSTRUCTS

Anchor implanted with the corresponding sutures passed through tendon in a cross configuration pattern.

Anchor implanted with the corresponding sutures passed through tendon in an x-configuration pattern.

Tie the violet ORTHOCORD Suture limbs to each other and cut the remaining suture tails.

Tie one violet ORTHOCORD Suture to one blue ORTHO-CORD Suture and cut remain-ing suture tails.

Tie the blue ORTHOCORD Suture limbs to each other and cut the remaining suture tails.

Tie the remaining violet ORTHOCORD Suture to the remaining blue ORTHOCORD Suture to cinch down the re-pair.

Cross Stitch Configuration

X-Stitch Configuration

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1 2 3

1 2 3

6 Mitek Sports Medicine HEALIX TRANSTEND Implant System DS

TWO-ANCHOR SINGLE-LOADED REPAIR CONSTRUCTS

Anchor implanted with the corresponding sutures passed through tendon in a box configuration pattern.

Anchor implanted with the corresponding sutures passed through tendon in a box configuration pattern.

Tie one violet ORTHOCORD Suture to one blue ORTHOCORD Suture and cut remaining suture tails.

Tie one violet ORTHOCORD Suture to one blue ORTHOCORD Suture and cut remaining suture tails.

Tie the remaining violet ORTHOCORD Suture to the remaining blue ORTHOCORD Suture to complete the repair.

Tie the remaining violet ORTHOCORD Suture to the remaining blue ORTHOCORD Suture to complete the repair.

Simple Stitch Configuration

Mattress Stitch Configuration

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HEALIX TRANSTEND Implant System DS Mitek Sports Medicine 7

HEALIX TRANSTEND Implant System and Instrumentation222337 HEALIX TRANSTEND (BR/1) Implant System (1 BR DS Anchor, PERCANNULA System) EA222338 HEALIX TRANSTEND (BR/2) Implant System (2 Single Loaded BR Anchors,

PERCANNULA System) EA222339 HEALIX TRANSTEND (PEEK/1) Implant System (1 PEEK DS Anchor, PERCANNULA System) EA222340 HEALIX TRANSTEND (PEEK/2) Implant System (2 Single Loaded PEEK Anchors,

PERCANNULA System) EA222341 HEALIX TRANSTEND BR w/Single BLUE #2 ORTHOCORD EA222342 HEALIX TRANSTEND PEEK w/Single BLUE #2 ORTHOCORD EA222343 HEALIX BR 3.4-mm DS #2 ORTHOCORD EA222344 HEALIX PEEK 3.4-mm DS #2 ORTHOCORD EA222261 HEALIX TRANSTEND (BR/1) Implant System (1 BR Anchor, PERCANNULA System) EA222263 HEALIX TRANSTEND (BR/2) Implant System (2 BR Anchors, PERCANNULA System) EA222278 HEALIX TRANSTEND (PEEK/1) Implant System (1 PEEK Anchor, PERCANNULA System) EA222280 HEALIX TRANSTEND (PEEK/2) Implant System (2 PEEK Anchors, PERCANNULA System) EA222266 HEALIX TRANSTEND (Ti/1) Implant System (1 Ti Anchor, PERCANNULA System) EA222268 HEALIX TRANSTEND (Ti/2) Implant System (2 Ti Anchors, PERCANNULA System) EA222273 HEALIX TRANSTEND 3.4-mm Awl/Tap (for BR and PEEK Anchors) 1/box222281 HEALIX TRANSTEND 2.2-mm Drill Bit (optional for Ti anchor) 1/box

PERCANNULA System 222274 PERCANNULA System 1/box

Instrument to complement the HEALIX TRANSTEND Implant System Technique270120 Grasper-Grabber Suture/Tendon Grabber 1/box

The IDEAL Suture Management FamilyCHIA PERCPASSER214101 CHIA PERCPASSER Suture Passer 5/box

IDEAL Suture Grasper251720 IDEAL Suture Grasper, 15º 1/box251721 IDEAL Suture Grasper, 30º 1/box251722 IDEAL Suture Grasper, 45º 1/box251723 IDEAL Suture Grasper, 60º 1/box

IDEAL Suture Shuttle with CHIA251001 IDEAL Suture Shuttle, 25º Left 1/box251002 IDEAL Suture Shuttle, 25º Right 1/box251003 IDEAL Suture Shuttle, 45º Left 1/box251004 IDEAL Suture Shuttle, 45º Right 1/box251005 IDEAL Suture Shuttle, 90º Up 1/box251006 IDEAL Suture Shuttle, Straight Hook 1/box251007 IDEAL Suture Shuttle, Straight Crescent 1/box

Clear Cannula System214104 Clear Cannula Threaded, 5.5 mm x 55 mm 5/box214106 Clear Cannula Smooth, 5.5 mm x 75 mm 5/box214107 Clear Cannula Smooth Distal Rib, 5.5 mm x 75 mm 5/box214108 Clear Cannula Threaded, 5.5 mm x 75 mm 5/box214110 Clear Cannula Threaded, 5.5 mm x 90 mm 5/box214114 Clear Cannula Smooth, 7.0 mm x 75 mm 5/box214115 Clear Cannula Smooth Distal Rib, 7.0 mm x 75 mm 5/box214116 Clear Cannula Threaded, 7.0 mm x 75 mm 5/box214118 Clear Cannula Threaded, 8.5 mm x 55 mm 5/box214120 Clear Cannula Threaded, 8.5 mm x 75 mm 5/box214122 Clear Cannula Threaded, 8.5 mm x 90 mm 5/box

ORDERING INFORMATION

Reference: 1. Zhang QS, Liu S, Zhang Q, Xue Y, Ge D, O’Brien MJ, Savoie FH, You Z. Comparison of the Tendon Damage Caused by Four Different Anchor Systems Used in Transtendon Rotator Cuff Repair.

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For more information, contact your Mitek Sports Medicine sales representative.

Johnson & Johnson Medical LimitedPinewood CampusNine Mile RideWokingham, BerkshireEnglandRG40 3EWUnited Kingdom

DePuy International Limited St. Anthony’s RoadBeestonLeedsWest YorkshireLS11 8DTUnited KingdomTel: +44 (0) 113 387 7800Fax: +44 (0) 113 387 7890

DePuy Mitek, Inc.325 Paramount Dr. Raynham, MA 02767USATel: +1 (800)382-4682

depuysynthes.com

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.

Third party trademarks used herein are trademarks of their respective owners.

Not all products are currently available in all markets.

This publication is not intended for distribution in the USA.

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