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Overstitch - detailed info on this new endoluminal platform

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Overstitch - the new offering from Apollo Endosurgery

Overstitch - the new offering from Apollo Endosurgery

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  • 1. OVERSTITCH™ ENDOSCOPIC SUTURING SYSTEM (ESS) INSTRUCTIONS FOR USECaution:Please read all instructions prior to use STERILE EOSINGLE PATIENT USEDISPOSABLE
  • 2. Sterile. Sterilized with ethylene oxide gas. Single use only. Disposable. Do not resterilize. Caution: Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician. Patent Pending DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ON THE APOLLO ENDOSURGERY, INC. PRODUCT(S) DESCRIBED IN THIS PUBLICATION. UNDER NO CIRCUMSTANCES SHALL APOLLO ENDOSURGERY, INC. BE LIABLE FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC LAW. NO PERSON HAS THE AUTHORITY TO BIND APOLLO ENDOSURGERY, INC. TO ANY REPRESENTATION OR WARRANTY EXCEPT AS SPECIFICALLY SET FORTH HEREIN. DESCRIPTIONS OR SPECIFICATIONS IN APOLLO ENDOSURGERY, INC PRINTED MATTER, INCLUDING THIS PUBLICATION, ARE MEANT SOLELY TO GENERALLY DESCRIBE THE PRODUCT AT THE TIME OF MANUFACTURE AND DO NOT CONSTITUTE ANY EXPRESS WARRANTIES. APOLLO ENDOSURGERY, INC. WILL NOT BE RESPONSIBLE FOR ANY DIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM REUSE OF THE PRODUCT. OverStitchTM Endoscopic Suturing System Reorder Number: ESS-G00-000 OverStitchTM 3-0 Polyglycolic Acid (PGA) Suture Reorder Number: PGA-G30-000 OverStitchTM 2-0 Polypropylene Suture Reorder Number: PLY-G20-000 OverStitchTM 3-0 Polypropylene Suture Reorder Number: PLY-G30-000 OverStitchTM Suture Cinch Reorder Number: CNH-G00-0002
  • 3. 1 General System Description The OverStitch product family is comprised of three devices which include the Endoscopic SuturingThe Apollo Endosurgery OverStitchTM Endoscopic System (ESS), a choice of Suture, and a SutureSuturing System (ESS) provides physicians the Cinch. All devices are delivered sterile and sealedability to perform tissue apposition within the in protective packaging.Gastrointestinal (GI) Tract. Additionally, the systemallows the surgeon to ‘reload’ the suture without the The Endoscopic Suturing System is comprised of aneed for removing the endoscope. System Handle, an End Cap, and an Anchor Exchange. The End Cap contains a Suturing Arm which tradesThe ESS works by delivering a proprietary Anchor an Anchor with the Anchor Exchange and performsand Suture through the channel of the endoscope the stitching operations. The opening and closingand passing both to the Suturing Arm. As necessary, of the Suturing Arm is controlled by the Handle Grip.a tissue retractor can be passed down the scope’s The system contains a Retention Wire that ensuressecond channel to pull tissue into the plane of the the End Cap does not inadvertently disengage fromESS’s Suturing Arm. The ESS has the ability to pass the tip of the endoscope. The Anchor Exchangethe Anchor through a full thickness bite of tissue. allows for the endoscopic loading and recapture ofThis process can be repeated for placement of a an Anchor and Suture.continuous row of running stitches or terminatedfor an interrupted stitch. To secure each Suture aCinch is passed down the scope’s primary channeland the user deploys the Cinch while applying thedesired amount of suture tension. Anchor Exchange End Cap System Handle Loading Tube Channel Adapter Retention Device Bracket Figure 1: Endoscopic Suturing System in the shipping tray (lid removed) 3
  • 4. Tissue Guard Actuation Catheter Suture Arm Needle Guard Figure 2: End Cap – Works in conjunction with the Anchor Exchange to place Stitches Handle Grip (Blue) Handle Grip Lock Coupling Ring Dial Lock Bracket Coupling Thumb Button Length Calibration Dial Override Switch Handle Body (White) Override Knob Retention Wire Bead Figure 3: System Handle – Controls operations of the End Cap4
  • 5. The OverStitch Sutures consist of an Anchor and Suture CassetteSuture combination that was designed to specifically Tabwork with the Endoscopic Suturing System. TheSuture system was also designed to allow theAnchor to serve as a t-tag, securing the Sutureafter placement. Each Suture is delivered in aSuture Cassette for ease of handling. The Sutureis offered in a combination of a 2-0 or 3-0 sizes inbraided absorbable suture (PGA) or monofilamentnonabsorbable (Polypropylene). The Sutures meetabsorbable and nonabsorbable surgical suturerequirements established by the United StatesPharmacopeia (U.S.P.). Figure 4: Suture Cassette – the Anchor is recessed below the TabPolyglycolic Acid (PGA) Suture is a coated, braided Suturesynthetic absorbable surgical suture. It is violet Anchorin color and is coated for lubricity. The in-vitroretention strength is 73.0% ± 6.0% at 14 days andis 45.0% ± 6.5% at 21 days. The material absorbsby hydrolysis in 60 to 90 days with virtually notissue reaction. The material is supplied sterile.Polypropylene Suture is a nonabsorbable surgicalsuture that is blue in color. The polypropylene sutureelicits a minimal acute inflammatory reaction intissues, which is followed by gradual encapsulation Figure 5: Enlarged image of the Anchor and Sutureof the suture of fibrous connective tissue. Thesesutures are nonabsorbable and no significantchange in strength retention is known to occur in vivo. Suture Loading TabThe Suture Cinch consists of an instrument todeliver an implantable suture cinch that maintainsthe desired suture tension. Cinch Handle Figure 6: Suture Cinch Safety Tab 5
  • 6. 2 Intended Use • Discard open, unused Sutures. • Users should be familiar with surgicalThe Apollo Endosurgery Endoscopic Suture System procedures and techniques involvingis intended for endoscopic placement of suture(s) absorbable sutures before employingand approximation of soft tissue. Synthetic Absorbable Sutures for wound closure, as the risk of wound dehiscence3 Contraindications may vary with the site of application andContraindications include those specific to use of an the suture material used.endoscopic suturing system, and any endoscopic • Do not remove the Safety Tab from theprocedure, which may include, but not limited to, Suture Cinch handle until the Suture Cinchthe following: is ready for final deployment; early removal of the Safety Tab will result in premature • This system is not for use when endoscopic engagement of the Suture Cinch onto techniques generally are contraindicated. the Suture • This system is not for use with malignant • Do not re-sterilize or reprocess tissue. • Absorbable sutures, should not be used 5 Precautions where extended approximation of tissue is required. • All packaged product should be stored in a cool, dark, dry place.4 Warnings • The System may only be used if purchased from Apollo Endosurgery, Inc. or one of its • Do not use a device where the integrity of authorized agents. the sterile packaging has been compro- mised or if the device appears damaged. • With the Endoscopic Suturing System installed, the endoscope’s primary channel • Only physicians possessing sufficient skill effectively becomes a 3.4-mm channel, and and experience in similar or the same the secondary channel effectively becomes techniques should perform endoscopic a 2.3-mm channel. procedures. • Use in the Lower Gastrointestinal tract is • Do not attempt to open the Suturing Arm only recommended when accompanied by in a confined space. Ensure adequate an access port. clearance for the fully opened Suturing Arm prior to use • Use of the Endoscopic Suturing System and the system components has not been studied • When intubating or extubating with the in the esophagus. There is no data on file to Endoscopic Suturing System, ensure that show safety or efficacy of the product in this the endoscope body and the Actuation anatomy. Catheter are retracted together. • Use caution when maneuvering the system • Ensure that the Handle Grip of the when loaded with an Anchor to avoid Endoscopic Suturing System is closed and unintended contact with delicate tissue. locked during intubation and extubation. • The contents of the system and the system • Do not force the Anchor Exchange if resistance as a whole are not intended for reprocessing is encountered during introduction through or re-sterilization. the scope. Reduce the endoscope angulation until the device passes smoothly. • Ensure that adequate Suture tension is maintained during introduction of the Suture Cinch. • With the device installed on the scope, accessories designed to hold the endoscope alone may no longer securely hold onto the endoscope.6
  • 7. 6 Adverse Events: Possible complications 7.2 Endoscope Selection and that may result from using the Endoscopic Preparation: Suturing System include, but may not be 7.2.1 The endoscope must be an Olympus limited to: GIF-2T160. • Hemorrhage 7.2.2 Prepare scope as per institutional • Hematoma guidelines. • Infection / Sepsis 7.2.3 Remove the channel caps from the • Pharyngeal, colonic and/or esophageal endoscope if they are installed. perforation 7.3 Endoscopic Suturing System • Esophageal, colonic and/or pharyngeal Preparation: laceration • Intra-abdominal (hollow or solid) visceral 7.3.1 Remove the pouched Endoscopic injury Suturing System from the packaging. • Aspiration Warning: Do not use a device where the integrity of the sterile packaging • Wound dehiscence has been compromised or if the • Acute inflammatory tissue reaction device appears damaged. • Death 7.3.2 Open the pouch and transfer the7 Preparations for Use (sterile) tray to a sterile table. 7.1 Recommended Accessories: • Olympus GIF-2T160 Endoscope • Guardus Esophageal Overtube from US Endoscopy (P/N 00711149) • Minos Overtube (Order Code: OT-22-80) • Water soluble lubricant • 2.3-mm Rat-Tooth Grasper (MediGlobe P/N 817460) or similar • 2.3-mm Alligator-Tooth Grasper (MediGlobe P/N 821460) or similar • Olympus Loop Cutter (FS-5U-1) • Apollo Endosurgery Flexible Endoscopic Scissors (FES-235-L32) • 20-ml Slip Fit Syringe 7
  • 8. 7.3.3 Locate the Channel Adapter Bracket and install it onto the endoscope as illustrated: Channel Adapter Bracket7.3.4 Locate the Retention Device and install it onto the secondary channel side of the Channel Adapter Bracket. Push down and turn the Retention Device counter-clockwise until it is secure: Retention Device8
  • 9. 7.3.5 Locate the Loading Tube. Install it into the End Cap Retainer and push down until the tube bottoms as shown: Loading Tube7.3.6 Locate the Retention Wire on the End Cap of the Endoscopic Suturing System and back-load itinto the scope’s secondary channel until the End Cap sits flush with the face of the scope: Retention Wire End Cap Retention Wire7.3.7 Remove the Loading Tube from the End Cap Retainer. 9
  • 10. 7.3.8 Rotate the Retention Wheel on the Retention Device and slide the Retaining Wire Bead into the groove: Retention Wheel7.3.9 Connect the Endoscopic Suturing System’s Bracket Coupling to the Channel Adapter Bracket by twisting clockwise:10
  • 11. 7.3.10 To aid in maintaining insufflation pressure and/or vacuum pressure, place the Plug into the lumen of the End Cap Retainer: Plug7.3.11 After installing the Endoscopic Suturing System assembly onto the endoscope, tape the Actuation Catheter to the body of the scope in an area that will remain outside of the patient. This helps to ensure the catheter and scope travel together as a system. 11
  • 12. 8 Loading a Suture and Anchor: 8.1 Open the Handle Grip of the Endoscopic Suturing System. The Anchor Exchange cannot be loaded or removed from the System Handle if the Handle Grip is closed. 8.2 Select the appropriate Suture size and type for the desired procedure 8.3 Remove the Suture Cassette from Anchor Exchange the sterile pouch Warning: Do not use a device where the integrity of the sterile packaging has been compromised or if the device appears damaged. 8.4 Remove the blue Tab from the front of the Suture Cassette to expose the Anchor 8.5 Insert the tip of the Anchor Exchange into the Suture Cassette to engage the Anchor. An audible / tactile “Click” confirms the Anchor is fully seated in the Anchor Exchange 8.6 Introduce the Anchor Exchange Anchor Exchange down the Handle Body through the Locking Knob working channel of the scope. The slot in the side of the Handle Body was made to accommodate the Suture. Anchor Exchange Warning: Do not force the Anchor Alignment Pins (Two) Exchange if resistance is encountered during introduction through the scope. Reduce the endoscope angulation until the device passes smoothly. 8.7 Continue to advance the Anchor Exchange and align both Alignment Pins with the handle slot. Continue until it is fully inserted into the handle then turn the Anchor Exchange Locking Knob counter-clockwise.12
  • 13. 9 Setting the length of the 9.1.5 Shuttle the System Handle back out. Endoscopic Suturing System 9.1.6 Open the Dial Lock on the Length for the individual scope: Calibration Dial 9.1.7 Turn the Length Calibration Dial 9.1 Set-up Procedure Using clockwise several clicks. Endoscopic Visualization 9.1.8 Shuttle the System Handle down SLOWLY. Note: the system length only needs to be set once at the start of each procedure 9.1.9 Endoscopically look for the Length Adjustment Mark. 9.1.1 If not already completed, connect the endoscope to the endoscopic 9.1.10 The ideal location for the Length tower and power the endoscope “ON” Adjustment Mark is when the middle of the mark lines up with the upper 9.1.2 Lay the endoscope and Endoscopic edge of the end cap’s Tissue Guard, Suturing System flat on a table as shown below. Continue to turn 9.1.3 If closed, open the Endoscopic the Length Calibration Dial until the Suturing System Handle Grip Length Adjustment Mark lines up 9.1.4 Shuttle the System Handle down with the upper edge of the Tissue and endoscopically look for the Guard, as shown: Length Adjustment Mark on the Anchor Exchange catheter. At this point the Length Adjustment Mark will likely be inside of the scope indicating that the user needs to lengthen the device Length Adjustment Mark Dashed Line Drawn Across the Upper Edge of the Tissue Guard 13
  • 14. 9.1.11 Once in position, engage the Dial 9.2.6 Turn the Length Calibration Dial Lock on the Length Adjustment Dial clockwise several clicks. to secure the system position. 9.2.7 Shuttle the System Handle down 9.1.12 Remove the System Handle from SLOWLY. “override” mode by turning the 9.2.8 Look for the Length Adjustment Override Knob on the left side of Mark. the handle toward the user. 9.2.9 The ideal location for the Length 9.2 Set-up Procedure Using the Adjustment Mark is when the middle Unaided Eye of the mark lines up with the upper edge of the end cap’s Tissue Guard, 9.2.1 Lay the endoscope and Endoscopic as shown below. Continue to turn Suturing System flat on a table the Length Calibration Dial until the 9.2.2 If closed, open the Endoscopic Length Adjustment Mark lines up Suturing System Handle Grip with the upper edge of the Tissue Guard, as shown: 9.2.3 Shuttle the System Handle down and look for the Length Adjustment 9.2.10 Once in position, engage the Dial Mark on the Anchor Exchange Lock on the Length Adjustment Dial catheter. At this point, the Length to secure the system position. Adjustment Mark will likely be inside 9.2.11 Remove the System Handle from of the scope indicating that the user “override” mode by turning the needs to lengthen the device Override Knob on the left side of 9.2.4 Shuttle the System Handle back out. the handle toward the user. 9.2.5 Open the Dial Lock on the Length Calibration Dial Length Adjustment Mark to be centered at the top of the End Cap’s tissue guard14
  • 15. 10 Device Insertion: the endoscope to accommodate opening of the Suturing Arm 10.1 Ensure that the Suturing Arm at the Warning: Do not attempt to open tip of the endoscope is in the closed the Suturing Arm in a confined space. position by locking the Handle Grip Ensure adequate clearance for the fully closed. The locking mechanism is opened Suturing Arm prior to use. engaged by squeezing the Handle Grip Lock while the Handle Grip is in 11.3 Once adequate clearance has been the closed position. established, open the Suturing Arm by squeezing and releasing the Warning: Ensure that the Handle Handle Grip Grip of the Endoscopic Suturing System is closed and locked during 11.4 With the aid of a grasper or similar intubation and extubation. device (2.3-mm compatible or smaller – refer to section 7.1), pull 10.2 Verify the System Handle is in a wedge of tissue into the suturing standard suturing mode by turning window. the Override Knob to the off position. Note, when the Override Knob is 11.5 When the tissue is aligned for suturing, sitting flush against the Handle Grip close the System Handle and surface the System Handle is in the activate the Handle Grip Lock standard suturing mode. If the (to lock the handle closed) Override Knob is raised above the 11.6 In one continual motion shuttle handle surface, simple turn the Override the System Handle completely Knob 90 degrees clockwise to en- downward and back to the original able the standard suturing mode. position 10.3 Generously lubricate the outside of 11.7 Open the System Handle by the endoscope and the Endoscopic squeezing the Handle Grip Suturing System with a water soluble 11.8 At this time, a grasper can be used lubricant. to push out extra suture length 10.4 Deliver the system to the physician’s 11.9 Adjust the endoscope position desired location through standard slightly to clear the tissue from the endoscopic techniques. End Cap 11.10 Close Handle Grip and engage the11 Suturing: Handle Grip Lock 11.1 With the device Handle Grip closed 11.11 Transfer the Anchor to the End and the Handle Grip Lock engaged, Cap’s Suturing Arm through the transfer the Anchor to the End Cap’s following actions: Suturing Arm through the following 11.11.1 Shuttle the System Handle actions: downward 11.1.1 Plunge the System Handle 11.11.2 When the System Handle downward bottoms out against the 11.1.2 When the System Handle scope depress and hold bottoms out against the the Thumb Button scope depress and hold 11.11.3 While holding the Thumb the Thumb Button Button down, shuttle the 11.1.3 While holding the Thumb System Handle back out Button down, shuttle the to it’s original position System Handle back out to 11.12 The endoscope can then be it’s original position maneuvered into position for placing 11.2 In preparation for stitching ensure that an additional stitch adequate clearance exists alongside 15
  • 16. 12 Dropping the Anchor 13.5 Slide the free end of the Suture through the window of the Suture In preparation for cinching the Anchor and Cinch’s Suture Loading Tab as Suture must be dropped at the treatment site shown below: 12.1 Place the System Handle into override mode by turning the Override Knob on the side of the System Handle away from the user. This will raise the Override Knob above the Handle Grip surface 12.2 Open the System Handle by squeezing the Handle Grip 12.3 Push down the thumb Override Switch until it ‘Clicks’ in the down position 12.4 Plunge the System Handle down until the Anchor is visible outside of the endoscope channel 12.5 Press and hold the Thumb Button to deposit the Anchor 12.6 After the Anchor was dropped shuttle the System Handle back to the original position 12.7 Remove the System Handle from “override” mode by turning the Override Knob on the left side of the handle toward the user13 Cinching 13.1 Ensure the endoscope has little to no articulation before performing the cinching operation. 13.6 Grasp the base of the Suture Loading 13.2 Open the System Handle by squeezing Tab and pull the device out of the the Handle Grip Suture Cinch 13.3 Completely remove the Anchor 13.7 To insert the Suture Cinch through Exchange from the System Handle the System Handle and the endoscope, by twisting the Locking Knob clockwise grasp the free end of the Suture and and pulling the device completely apply slight tension while the Suture out of the System Handle Cinch is advanced 13.4 Uncoil the cinch in preparation for use Warning: Ensure that adequate Warning: Do not remove the Safety Suture tension is maintained during Tab from the Cinch handle until the introduction of the Suture Cinch Cinch is ready for final deployment; early removal of the Safety Tab will result in premature engagement of the Cinch onto the Suture16
  • 17. 13.8 Extend the Suture Cinch out the 15 System Removal from the Endoscope: distal end of the scope 15.1 Rotate the Retention Wheel of the 13.9 Apply the desired amount of Suture Retention Device and slide the tension by pulling on the free end of Retaining Wire Bead out of the the Suture that extends out the Retention Wheel. System Handle 15.2 Remove the System Handle from the 13.10 Remove and discard the Safety Tab Channel Adapter Bracket by twisting from the Cinch Handle the Coupling Ring counter-clockwise 13.11 Actuate the Suture Cinch by firmly 15.3 Pull off the End Cap from the distal squeezing the handle. This will end of the endoscope and remove deploy the Suture Cinch and cut the the Retention Wire from within the remaining Suture. scope channel. 13.12 Using endoscopic visualization 15.4 Remove the Retention Device by ensure that the Suture is captured twisting it clockwise and the Suture Cinch is secure. 15.5 Slide up the Channel Adapter 13.13 Retract the Suture Cinch and excess Bracket and pull it off the scope. Suture. 15.6 Dispose of all devices and materials14 System Removal from the Patient: in a manner conducive to the hospital’s internal policies 14.1 To remove the device, make sure the End Cap is locked in the closed position by squeezing the Handle Grip and activating the Handle Grip lock. Warning: Ensure that the Handle Grip of the Endoscopic Suturing System is closed and locked during intubation and extubation. 14.2 While holding the Actuation Catheter on the outside of the endoscope, gently retract the endoscope an Endoscopic Suturing System from the patient. Warning: When intubating or extubating with the Endoscopic Suturing System, ensure that the endoscope body and the Actuation Catheter are retracted together. 17
  • 18. 16 TroubleshootingCurrent Condition Steps to Resolve Condition 1. If the Anchor is in the End Cap Suturing Arm, continue with this step; otherwise, go to step 2. a. Remove the Anchor Exchange from the device b. Pass a grasper through the handle to grab the Anchor or Suture and close the Suturing Arm. c. With the grasper holding the Suturing Arm closed, extract the Endoscopic Suturing System and endoscope together. 2. If the Anchor is not in the End Cap receptacle a. Remove the Anchor Exchange from the device b. Pass a grasper and/or snare down the primary channel to grab the Suturing Arm and pull it closed c. With the grasper holding the Suturing Arm closed, extract the Endoscopic Suturing System and endoscope together. 3. If unable to pull the End Cap Suturing Arm closed and an overtube is in place:End Cap Suturing ArmStuck Open a. Rotate the Retention Device Retention Wheel and remove the Retention Wire Bead. b. Remove the Anchor Exchange from the System Handle c. With a set of graspers, push against the End Cap until it releases from the endoscope. d. Gently manipulate the End Cap to pull it into the overtube – ensure the End Cap is not dragged through unprotected anatomy e. Remove using standard endoscopic technique. 4. If unable to pull the End Cap Suturing Arm closed and an overtube is not in place: Eject the End Cap and remove by the following means: a. Rotate the Retention Device Retention Wheel and remove the Retention Wire Bead. b. Remove the Anchor Exchange from the System Handle c. With a set of graspers, push against the End Cap until it releases from the endoscope. d. Gently retract the endoscope to the point where the End Cap is visually confirmed to be free of the endoscope. e. Continue retracting the scope while visually confirming that the Retention Wire continues to slide free of the endoscope.18
  • 19. Current Condition Steps to Resolve Condition (cont) f. Remove the endoscope from the patient g. Remove the System Handle from the Channel Adapter Bracket. h. Cut the System Handle free of the Actuation Catheter.End Cap Suturing Arm i. Back feed the End Cap’s Actuation Catheter and theStuck Open Retention Wire through a compatible overtube. j. While maintaining position of the End Cap’s Actuation Catheter, introduce the overtube into the patient. k. Once the End Cap is visible through the endoscope, utilize a compatible grasper to pull the End Cap into the overtube. l. Remove using standard endoscopic technique.Current Condition Steps to Resolve Condition First line of defense: 1. Ensure the System Handle is shuttled all of the way out 2. Open the System Handle by squeezing the Handle Grip – ensure the Handle Grip Lock is disengagedEnd Cap Suturing Arm 3. Gently steer the endoscope tip to allow the End Cap to open naturallyis Stuck in Tissue Severe Entrapment: Eject the End Cap and remove by the following means: 1. Follow the instructions on the prior section to insert an overtube and advance it to the End Cap. 2. Once the End Cap is visible through the endoscope, separate the End Cap assembly from the tissue using standard endoscopic techniques. 3. Pull the End Cap into the overtube and remove using standard endoscopic techniques.Current Condition Steps to Resolve Condition 1. Pass a compatible grasper down the secondary channel and grasp the Suture. While holding the graspers on the Suture, pull the Cinch out of the endoscope and the System Handle. If the Cinch cannot be removed from the system, continue to step 2. 2. Regardless of the location of the Cinch, ensure that Cinch hasSuture Cinch is stuck been fully deployed. If not, deploy the Cinch per the “Cinching”on the Suture section of the IFU. If the Cinch cannot be removed from the system after deployment, continue to step 3. 3. Remove any accessory from the endoscope’s secondary channel and pass the compatible loop cutter down the secondary channel. Use the loop cutter to cut the Suture between the surgical site and the Cinch. This will free the system for removal. 19
  • 20. Description Symbol Description Symbol Consult instructions for use Caution Consult accompanying documents Usage Restriction Do Not Resterilize (Single Use Only / Do Not Reuse) Sterile Expiration Date (Sterilized Using Ethylene Oxide) Catalog Number Lot Number Manufactured By Do not use if package has been opened or damaged Caution Federal law restricts this device to sale by or on the order of a (licensed healthcare practitioner) Apollo Endosurgery, Inc. 7000 Bee Caves Road, Suite 350 Austin, Texas 78746Copyright ©2010 Apollo Endosurgery, Inc. All rights reserved. GRF-00002-00R04

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