Clinical Use Information; Physician Training - aptus Heli-FX Instrucciones De Uso

EN
CAUTION: The EndoAnchor has undergone in vitro evaluations for compatibility and durability
with the endograft devices listed in the Warnings and Precautions section of this IFU (Section 4).
The transferability of these data to other endograft designs is not known and therefore use with
other endografts is not recommended.
CAUTION: The EndoAnchor has not undergone clinical evaluations in the thoracic or thoraco-abdominal
(suprarenal) aorta.
Pre-Clinical Data
Clinical data has been augmented with bench testing to evaluate the performance of the EndoAnchor
with additional AAA and TAA endografts, which have not undergone clinical evaluation with the
EndoAnchor. Bench testing included simulated procedural use and accelerated durability testing
(10-year equivalent). Durability testing was completed for the following AAA endografts: Cook Zenith®,
Gore Excluder®, and Medtronic AneuRx®, Endurant®, and Talent®. Bench evaluations demonstrated
that the following TAA endografts utilize the same graft material and construction as their
AAA counterparts; thus durability testing was not repeated: Cook Zenith TX2®, Gore TAG®,
and Medtronic Talent® TAA and Valiant®.
All of the evaluated endografts (AAA and TAA) demonstrated compatibility with the anchoring
procedure in an in vitro simulated use environment.
During accelerated durability testing, the Talent AAA endograft demonstrated minor elongation
of the EndoAnchor penetration location in three of eight (37.5%) of test samples. The maximum
hole elongation seen was 1.3 mm, as compared to the EndoAnchor wire diameter of 0.5 mm,
and this occurred between 300 and 400 million cycles (7.5 – 10 years equivalent). While this is
believed to be a result of the severe test conditions (worst-case axial loading and the lack of
incorporation of the migration resistance provided by the Talent's longitudinal connecting bars),
the EndoAnchor should be used with caution in Talent and Valiant endografts.

8.0 CLINICAL USE INFORMATION

Physician Training

Always refer to the Instructions for Use supplied with the endograft system or components with
which the EndoAnchors are being used to ensure proper training and techniques regarding the
endograft devices.
CAUTION: The Heli-FX EndoAnchor System should only be used by physicians and teams trained
in vascular interventional techniques, including endovascular aneurysm repair, and in the use
of this device.
The recommended skill, knowledge, and resource requirements for physicians using the Heli-FX
EndoAnchor System are outlined below:
• Knowledge of the complications associated with endovascular AAA and TAA repair.
• A multidisciplinary team that has combined procedural experience with:
– Vascular access and related complications
– Non-selective and selective guide wire and catheter techniques
– Fluoroscopic and angiographic image interpretation
– Snare techniques
– Appropriate use of radiographic contrast material
– Techniques to minimize radiation exposure
11