Clinical Data; Clinical Use Information - Medtronic Aptus Heli-FX Gebrauchsanweisung

7. Clinical data

Clinical study
The Heli-FX EndoAnchor system was evaluated in a prospective, single-arm, Investigational Device Exemption (IDE) trial enrolling 155 subjects (145 male, average age 73 years) at
25 centers in the United States. The studied system uses an identical EndoAnchor implant as the Heli-FX thoracic system. The EndoAnchor implant was evaluated in conjunction with
an investigational endograft in patients meeting standard elective infrarenal Endovascular aneurysm repair (EVAR) treatment criteria, including the specific proximal neck
characteristics as follows:
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Proximal neck length ≥ 12 mm
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Proximal neck diameters between 19 mm and 29 mm
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Proximal infrarenal neck angulation ≤ 60°, and
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Proximal neck thrombus, calcification and/or plaque ≤ 2 mm in thickness and ≤ 50% (180°) continuous coverage of the vessel circumference in the sealing zone
The data presented below were generated in the aforementioned clinical trial. This study was not prospectively designed or statistically powered to evaluate the safety and
effectiveness of the EndoAnchor implant as a stand-alone device; however, it contains important information related to the clinical use of the EndoAnchor implant. The investigational
endograft studied in conjunction with the EndoAnchor implant was designed specifically for use with the EndoAnchor implant, and is composed of a multifilament woven polyester
graft fabric with a nickel-titanium (Nitinol) sealing stent and unsupported main body architecture. This endograft is not marketed and is not among the named devices listed
in Section 4.
The study subjects were followed at 1, 6, and 12 months, and yearly thereafter per standard EVAR follow-up protocol. An independent core lab was employed to evaluate imaging-
related endpoints. The primary safety endpoint was freedom from major adverse events (MAE) at 30 days. MAEs were defined as death, Myocardial Infarction, stroke, renal failure,
respiratory failure, or paralysis. 4 MAEs occurred in 3 subjects (1.9%), compared to a reference rate of 11.1% for open surgical repair. The primary effectiveness endpoint was
successful aneurysm treatment at 1 year, defined as delivery success, absence of Type I/III endoleaks, absence of migration ≥ 10 mm, and absence of aneurysm rupture or late
conversion to open repair. Effectiveness was measured at 97.4%, compared to a reference rate of 80%. 4 subjects (2.6%) did not meet the primary effectiveness endpoint:
2 endograft component delivery failures at the index procedure, 1 intervention at 8 months postimplant to address a Type I endoleak, and one Type III endoleak identified by the core
lab at the 6-month follow-up period.
Physicians implanted a total of 810 EndoAnchor implants (range 2-14, median 5 per patient) in 154 subjects. EndoAnchor implantation took an average (SD) of 16.8 (11.8) minutes
(range 2-125 minutes). There have been no reported Unanticipated Adverse Device Effects (UADEs) associated with the EndoAnchor implant. Through 1-year follow-up, including
633 EndoAnchor implants in 119 subjects, the core lab did not observe any EndoAnchor implant fractures or any migrations of EndoAnchor implants from their implanted positions.
Through 1-year follow-up, no subjects had experienced proximal endograft migration and one subject had a secondary intervention to address a Type I endoleak (1/119, 0.8%), which
occurred in the absence of endograft migration in a circumferentially incomplete aortic neck. A single Type III endoleak (1/119, 0.8%), involving the separation of a proximal aortic cuff
from the bifurcated endograft device, occurred in a subject whose bifurcated device was not fixed using EndoAnchor implants prior to cuff placement. After 1 year, a single subject
was explanted in response to caudal endograft migration despite EndoAnchor implant usage. At least 2 of the 4 EndoAnchor implants were implanted in this subject into mural
thrombus in the aortic neck and did not actually penetrate the aortic wall.
Caution: The EndoAnchor implant has undergone in vitro evaluations for compatibility and durability with the endograft devices listed in 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 implant has not undergone clinical evaluations in the thoracic or thoraco-abdominal (suprarenal) aorta.
Preclinical data
Clinical data has been augmented with bench testing to evaluate the performance of the EndoAnchor implant with additional Abdominal Aortic Aneurysm (AAA) and Thoracic Aortic
Aneurysm (TAA) endografts, which have not undergone clinical evaluation with the EndoAnchor implant. 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 use 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 Medtronic Talent™ AAA endograft demonstrated minor elongation of the EndoAnchor implant penetration location in 3 of 8 (37.5%) of test
samples. The maximum hole elongation seen was 1.3 mm, as compared to the EndoAnchor implant wire diameter of 0.5 mm. This situation occurred between 300 million and
400 million cycles (7.5-10 years equivalent). While this observation is believed to be due to the severe test conditions (worst-case axial loading scenario and the lack of incorporation
of the migration resistance provided by the Medtronic Talent™ AAA endograft's longitudinal connecting bars), the EndoAnchor implant should be used with caution in Medtronic
Talent™ AAA and Valiant endografts.

8. Clinical use information

Physician training
Always refer to the Instructions for Use supplied with the endograft system or the components with which the EndoAnchor implants are being used to ensure proper knowledge of
techniques regarding the endograft devices.
Caution: The Heli-FX EndoAnchor system should only be used by physicians trained in the use of the device and in vascular interventional techniques, including endovascular
aneurysm repair.
The recommended skill, knowledge, and resource requirements for physicians using the Heli-FX EndoAnchor system include:
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Knowledge of the complications associated with endovascular AAA and TAA repair
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A multidisciplinary team that has combined procedural experience with:
Vascular access and related complications
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Nonselective and selective guidewire and catheter techniques
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Fluoroscopic and angiographic image interpretation
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Snare techniques
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Appropriate use of radiographic contrast material
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Techniques to minimize radiation exposure
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Inspection prior to use
Inspect the device and packaging to verify that no damage has occurred as a result of shipping. Do not use this device if damage has occurred or if the sterile barrier has been
damaged or broken. If damage has occurred, do not use the product. Return to Medtronic Vascular, Inc. or your distributor.
Do not use beyond the Use-by date indicated on the packaging.
Prior to use, verify correct devices (appropriate Heli-FX Applier and Guide models for the anatomy being treated and sufficient quantity of EndoAnchor implants) have been supplied
for the patient by matching the device to the order prescribed by the physician for that particular patient.
Recommended materials
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Heli-FX Guide with Obturator
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Heli-FX Applier with EndoAnchor Cassette
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16 Fr or 18 Fr (or larger) introducer sheath, if desired
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0.89 mm (0.035 in) guidewire, exchange length (260 cm or greater)
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Heparinized saline for catheter flush
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Alternative guidewires and other endovascular tools, per the physician's preference
Instructions for Use English 9