Medtronic EC-05 Instructions for Use
Heli-FX™ EndoAnchor™ Systems, comprising the Heli-FX Guides, Heli-FX Appliers, EndoAnchor implants, and EndoAnchor
Cassettes.
Instructions for Use
CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.
Read all Instructions carefully. Failure to properly follow the instructions, contraindications, warnings, and precautions may
lead to serious surgical consequences or injury to the patient.
© 2018 Medtronic. All rights reserved. Medtronic and Medtronic logo are trademarks of Medtronic. ™* Third party brands are
trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
Explanation of symbols that may appear on product labeling
Refer to the device labeling to see which symbols apply to this product.
Use-by date
Consult instructions for use at this website
Do not reuse
Catalog number
Lot number
Manufacturer
Do not use if package is damaged
Sterilized using ethylene oxide
Keep dry
Date of manufacture
MR Conditional
Quantity
Nonpyrogenic uid path
Nonpyrogenic uid path and implant
Nonpyrogenic implant
Debrillation-proof type CF applied part
IPX0 - no claim of protection from water ingress
Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable
European Union Acts.
Authorized Representative in the European Community
For US Audiences Only
Manufactured In
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Table of Contents
1.0 Product description .................................................................................................................. 6
2.0 Indications for use ................................................................................................................... 9
3.0 Contraindications ..................................................................................................................... 9
4.0 Warnings and precautions ....................................................................................................... 9
5.0 Adverse events ...................................................................................................................... 10
6.0 How supplied ..........................................................................................................................11
7.0 Clinical data ............................................................................................................................11
8.0 Clinical use information ......................................................................................................... 12
9.0 Directions for use ................................................................................................................... 13
10.0 Imaging guidelines and postoperative follow-up ................................................................... 18
11.0 Definitions .............................................................................................................................. 18
12.0 Storage, transport, and disposal ........................................................................................... 18
13.0 EMC guidance and declaration ............................................................................................. 19
14.0 Disclaimer of warranty ........................................................................................................... 21
Instructions for Use
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1.0 Product description
Heli-FX™ Applier
The Heli-FX Applier is a sterile, single-patient use disposable device designed to implant one EndoAnchor implant at a time.
EndoAnchor implants are loaded into the Applier from the EndoAnchor Cassette by placing the distal end of the Applier into
an unused EndoAnchor port that each holds one EndoAnchor implant.
Caution: The EndoAnchor implant has a sharpened leading edge. Use caution when handling an Applier loaded with an
EndoAnchor implant.
The Heli-FX Applier can be reloaded and deployed multiple times for the same patient. The Applier is composed of a catheter
and a control handle. The control handle includes indicator lights, control buttons, and a 9-volt alkaline battery-powered
motor. The motor controls the EndoAnchor implant rotation. Figure 1 provides details on the indicator lights and control
buttons. The user passes the Applier catheter through the lumen of the Heli-FX Guide until the distal end of the Applier
contacts the endograft and vessel wall.
The Applier is available in 2 lengths: 86 cm and 114 cm.
Classifications
• Internally powered equipment
• Type CF (debrillation-proof) applied part
• Type IPX0 for water ingress
• The equipment is not suitable for use in the presence of a ammable anesthetic mixture with air or with oxygen or nitrous
oxide.
• Mode of operation: continuous operation
The EndoAnchor implant is implanted in a 2 stage process to allow the physician to retract the EndoAnchor implant and
reposition it prior to nal deployment. Audible tones and visible lights during operation indicate the position of the EndoAnchor
implant and the available direction of motion. Figure 1 details the components of the Heli-FX Applier.
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Figure 1: Heli-FX Applier
1. Control handle
2. Catheter
3. Reverse control button
4. Forward control button
5. Green forward and reverse indicators
6. Error indicator
7. Flush port
Table 1 shows the Heli-FX Applier status and relevant lights, audible tones, and button denitions associated with each
status.
Table 1: Lights, audible tones, and buttons
Device Status Light Tone
Off Off None
Green Forward Arrow: Flashes
On/Self Check Sequence
Reverse Arrow: Flashes
Blue Indicator Light: Flashes
3 To nes
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Instructions for Use
Table 1: Lights, audible tones, and buttons
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Device Status Light Tone
Green Forward Arrow: Off
On/Ready
EndoAnchor Implant Loaded
Deployed to Pause State
Deployment Complete
Error
Button Actions
Forward Control Button Deploys an EndoAnchor Implant Forward
Reverse Control Button
Green Reverse Arrow: Flashes
Blue Indicator Light: Off
Green Forward Arrow: Flashes
Green Reverse Arrow: Off
Blue Indicator Light: Off
Green Forward Arrow: Flashes
Green Reverse Arrow: Flashes
Blue Indicator Light: Off
Green Forward Arrow: Off
Green Reverse Arrow: Flashes
Blue Indicator Light: Off
Green Forward Arrow: Off
Green Reverse Arrow: Flashes
Blue Indicator Light: Flashes
(a) Turns Heli-FX Applier On; (b) Loads an EndoAnchor implant; or (c) Withdraws
an EndoAnchor implant back in to the Applier from the Pause State
No Tones
2 To nes
4 To nes
3 To nes
4 To nes
EndoAnchor Implant and EndoAnchor Cassette
The EndoAnchor implant is designed to attach an endograft to the vessel wall. The EndoAnchor implant is manufactured from
0.5 mm diameter medical-grade wire. The EndoAnchor implant is approximately 4.5 mm in total length and approximately
3 mm in diameter. The sharp, leading end facilitates atraumatic deployment through the graft material and vessel wall. The
EndoAnchor implant also penetrates diffusely calcied tissue up to 2.0 mm thick. The cross-bar located at the proximal end
of the EndoAnchor implant prevents overpenetration of the implant. The body of the EndoAnchor implant has a helical shape,
allowing the EndoAnchor implant to engage tissue and attach the endograft to the vessel wall. Figure 2 is an illustration of the
EndoAnchor implant. 10 EndoAnchor implants are packaged in a sterile cassette allowing for easy and accurate loading into
the Heli-FX Applier. Figure 3 is an illustration of the EndoAnchor Cassette. Additional EndoAnchor implants are available in
an ancillary Cassette that contains 5 EndoAnchor implants.
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Figure 2: EndoAnchor Implant
1. Crossbar
Figure 3: EndoAnchor Cassette
1. EndoAnchor ports
2. Leading end
Heli-FX Guide with Obturator
The Heli-FX Guide is a sterile, single patient use, disposable device that directs the Heli-FX Applier to the desired location for
implanting EndoAnchor implants. The Heli-FX Guide consists of a steerable guide catheter and control handle. The Obturator
(included with the Heli-FX Guide) has an atraumatic tip. The thoracic Obturator has a radiopaque marker within 2 mm of its
tip. The Obturator, which is compatible with a 0.89 mm (0.035 in) guidewire, allows the Guide to be advanced over the wire
within the patient's vasculature.
Rotating the deector knob on the control handle allows the distal tip of the Heli-FX Guide to be deected in a single direction
or straightened
A C-shaped radiopaque marker, located at the distal tip of the Heli-FX Guide, aids in orientation under uoroscopy. A straight
radiopaque marker, located at the outer curve of the deectable section of the Guide, indicates the direction of tip deection.
Figure 4 details the components of the Heli-FX Guide.
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Instructions for Use
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