INDICATIONS, SAFETY, AND WARNINGS Heli-FX EndoAnchor System

Indications For Use

The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery.  The Heli-FX EndoAnchor System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.  The EndoAnchorimplant may be implanted at the time of the initial endograft placement, or during a secondary (i.e. repair) procedure.


Contraindications

Treatment with the Heli-FX EndoAnchor system is contraindicated for use in the following circumstances:

  • In patients with known allergies to the EndoAnchor implant material (MP35N-LT)
  • In conjunction with the Endologix Powerlink™* endograft 

Warnings

  • The long-term performance of the EndoAnchor implant has not been established.  All patients should be advised endovascular aneurysm treatment requires long-term, regular follow-up to assess the patient’s health status and endograft performance, and the EndoAnchor implant does not reduce this requirement.
  • The EndoAnchorimplant and the Heli-FX™ EndoAnchor System and Heli-FX™ Thoracic EndoAnchor™ system have been evaluated via in vitro testing and determined to be compatible with the Cook Zenith™*, Cook Zenith™* TX2™*, Gore Excluder™*, Gore TAG™*, Jotec E™*-vita abdominal, Jotec E™*-vita thoracic, Medtronic AneuRx, Medtronic Endurant, Medtronic Talent, and Medtronic Valiant™ endografts.  Use with endografts other than those listed above has not been evaluated.
  • The performance of the EndoAnchor implant has not been evaluated for securing multiple endograft components to one another.  Not securing EndoAnchor implants into aortic tissue could result in graft fabric damage, component separation, and resultant Type III endoleaks.
  • The performance of the EndoAnchor implant has not been evaluated in vessels other than the aorta.  Use of the EndoAnchor implant to secure endografts to other vessels may result in adverse patient consequences such as vascular perforation, bleeding, or damage to adjacent structures.
  • The performance of the EndoAnchor implant has not been evaluated for securing multiple anatomical structures together.  Such use could result in adverse patient consequences such as vascular perforation, bleeding, or embolic events.

MRI Safety And Compatibility

  • The EndoAnchor implants have been determined to be MR Conditional at 3T or less when the scanner is in Normal Operating Mode with whole body averaged SAR of 2 W/kg, or in First Level Controlled Mode with a maximum whole body averaged SAR of 4 W/kg.
  • Please refer to documentation provided by the endograft system manufacturer for MR safety status of the endograft system with which the EndoAnchor implants are being used.

Potential Adverse Events

Possible adverse events associated with the Heli-FX™ EndoAnchorsystem include, but are not limited to:

  • Aneurysm rupture
  • Death
  • EndoAnchor™ implant embolization
  • Endoleaks (Type III)
  • Enteric fistula
  • Failure to correct/prevent Type I endoleak
  • Failure to prevent endograft migration
  • Infection
  • Renal complications (renal artery occlusion/dissection or contrast-induced AKI)
  • Stroke
  • Surgical conversion to open repair
  • Vascular access complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula
  • Vessel damage, including dissection, perforation, and spasm

Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for full product information.

CAUTION: EndoAnchor implant locations should be based upon a detailed examination of the preoperative CT imaging in cases involving irregular or eccentric plaque in the intended sealing zone(s).  EndoAnchor implants should be implanted only into areas of aortic tissue free of calcified plaque or thrombus, or where such pathology is diffuse and less than 2mm in thickness.  Attempting to place EndoAnchor implants into more severe plaque or thrombus may be associated with implantation difficulty and suboptimal endograft fixation and/or sealing. 

FTSOP113326-33 Rev. 1D