HG-16-62-28

Image of the Heli-FX™ EndoAnchor™ system including deflecting guide catheter with cassette containing EndoAnchors.

Indications, Safety, and WarningsMRI Safety InformationIndications for useThe 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 EndoAnchor™ implant may be implanted at the time of the initial endograft placement or during a secondary (i.e., repair) procedure.ContraindicationsTreatment 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 visits to assess the patient’s health status and endograft performance. The EndoAnchor™ implant does not reduce this requirement.

The EndoAnchor™ implant and the Heli-FX™ 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™*, Medtronic AneuRx™, Medtronic Endurant™, Medtronic Talent™ AAA, Medtronic Talent™ TAA, Medtronic Valiant™ Xcelerant™, Medtronic Valiant™ Captivia™, and Medtronic Valiant™ Navion™ 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 together. 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.

Potential adverse eventsPossible adverse events that are associated with the Heli-FX™ EndoAnchor™ system 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 acute kidney injury)

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. Additional potential adverse events may be associated with endovascular aneurysm repair in general. Refer to the instructions for use provided with the endograft for additional potential adverse events.Caution: Federal law (United States) 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 zones. 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 2 mm 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. TM* Third party brands are trademarks of their respective owners.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.

Not what you're looking for?

United States

Customer Care Team