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NeoChord DS1000 Instructions For Use Manual

Artificial chordae delivery system
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INSTRUCTIONS FOR USE

NeoChord
™
Artificial Chordae Delivery System
Model DS1000
™
For Export Only
NeoChord, Inc.
5402 Parkdale Drive, Suite 160
St. Louis Park, Minnesota 55416, U.S.A.
Phone: (952) 698 7800
NEOCHORD and the stylized NeoChord logo are registered trademarks of the NeoChord Corporation.
700010-002 Rev 5
DCN 0670, 26-Dec-2018
Page 1 of 12

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Summary of Contents for NeoChord DS1000

  • Page 1: Instructions For Use

    NeoChord, Inc. 5402 Parkdale Drive, Suite 160 St. Louis Park, Minnesota 55416, U.S.A. Phone: (952) 698 7800 NEOCHORD and the stylized NeoChord logo are registered trademarks of the NeoChord Corporation. 700010-002 Rev 5 DCN 0670, 26-Dec-2018 Page 1 of 12...

  • Page 2: Device Description

    The DS1000 deploys artificial chordae using commercially available ePTFE suture material, labeled for use as artificial chordae tendinae. The NeoChord DS1000 is an integrated modular system consisting of a hand-held delivery instrument, a cartridge in which...
  • Page 3 • The NeoChord DS1000 is sterilized using EtO and is for single use only. Do not reuse or resterilize. Attempts to reuse or resterilize the device may result in patient harm, device malfunction, or inadequate sterilization.

  • Page 4: Potential Adverse Events

    POTENTIAL ADVERSE EVENTS The potential risks associated with the use of the NeoChord DS1000 System include the following: • Air embolism • Failure to deliver ePTFE artificial chord to intended leaflet site • Allergic reaction • Mitral regurgitation (>3) •...

  • Page 5: Implantation Procedure

    9.3. IMPLANTATION PROCEDURE: The NeoChord DS1000 procedure occurs in five steps: (i) Device Preparation; (ii) Left Ventricular Access; (iii) Leaflet Capture and Verification; (vi) Suture Deployment and (v) Suture Closure. The sutures are placed via a ventriculotomy 2-4 cm postero-lateral from the apex of the left ventricle via thoracotomy.
  • Page 6 9.4.2. Locate the center of the ePTFE suture and create a gentle fold using care to not damage the suture. Holding the NeoChord DS1000 cartridge assembly in one hand with the distal clamp pointed toward the ceiling; thread the folded end of the ePTFE suture through the proximal opening on the underside of the cartridge assembly.
  • Page 7 9.4.8. Select the handle from the sterile packaging and align the proximal end of the cartridge assembly with the distal end of the handle. The cartridge assembly and handle are grooved to create a channel for attachment. Slide the cartridge assembly into the handle.
  • Page 8 9.4.11. Thoroughly rinse the needle and delivery system in sterile heparinized saline making sure to keep the LCV monitor dry and out of the saline. 9.4.12. The device is now ready for use. 9.5. Left Ventricular Access: 9.5.1. Define the thoracic anatomy using x-ray and echo. 9.5.2.
  • Page 9 9.6.5. Confirmation of leaflet capture is accomplished by examining the fiber optic display. Four white lights on the monitor display confirm that leaflet tissue is captured within the distal clamp. CAUTION: If any light is illuminated red, release the leaflet and repeat this step. Partial Complete Capture...

  • Page 10: Postoperative Considerations

    9.8.5. Close the incision area as appropriate. POSTOPERATIVE CONSIDERATIONS Patients who receive at least one artificial chordae using the NeoChord DS1000 should be managed per the normal standard of care for cardiac implants. As such, a standard anticoagulation regimen for similar cardiac implants such as an annuloplasty ring is recommended.

  • Page 11: Electromagnetic Compliance

    Guidance and manufacturer’s declaration – electromagnetic emissions The DS1000 is intended for use in the electromagnetic environment specified below. The customer or the user of the DS1000 should assure that it is used in such an environment.

  • Page 12: Warranty And Limitations

    NeoChord, Inc. will not be liable for any incidental, special or consequential loss, damage or expense, direct or indirect, from the use of its product. NeoChord’s sole obligation shall be to repair or replace at its option, any device that we feel was defective at time of shipment if notice thereof is received within six (6) months.

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