Clinical Data - aptus Heli-FX Instrucciones De Uso

7.0 CLINICAL DATA

Clinical Study
The Heli-FX EndoAnchor System was evaluated in a prospective, single-arm, 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 was evaluated in
conjunction with an investigational endograft in patients meeting standard elective infrarenal EVAR
treatment criteria, including the specific proximal neck characteristics as follows:
• Proximal neck length ≥ 12 mm in length
• Proximal neck diameters between 18 mm and 29 mm
• Proximal neck angulation ≤ 60°, and
• 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 as a stand-alone device; however, it contains important information related to the clinical
use of the EndoAnchor. The investigational endograft studied in conjunction with the EndoAnchor
was designed specifically for use with the EndoAnchor, and is composed of a multi-filament woven
polyester graft fabric with a nickel-titanium (nitinol) sealing stent and unsupported main body
architecture. This endograft remains investigational and is not among the named devices listed
in the Warnings and Precautions section above.
The study subjects were followed at one, six, and twelve 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, MI, stroke, renal failure, respiratory failure, or paralysis. Four 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 one year, defined as delivery success,
absence of Type I/III endoleaks, absence of migration ≥ 10 mm, and absence of aneurysm rupture
or late conversion. Effectiveness was measured at 97.4%, versus a reference rate of 80%. Four
subjects (2.6%) did not meet the primary effectiveness endpoint - these included two endograft
component delivery failures at the index procedure, one intervention at eight months post-implant
to address a Type I endoleak, and one Type III endoleak identified by the core lab at the six-month
follow-up period.
A total of 810 EndoAnchors (range 2 – 14, median 5 per patient) were implanted 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 (UADE) associated with the
EndoAnchor. Through one-year follow-up, inclusive of 633 EndoAnchors in 119 subjects, there were
no EndoAnchor fractures as observed by the core lab, and no migrations of EndoAnchors from their
implanted positions. Through one-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
EndoAnchors prior to cuff placement. Beyond one year, a single subject was explanted in response
to caudal endograft migration despite EndoAnchor usage. In this subject at least two of the four the
EndoAnchors were implanted into thrombus in the aortic neck and did not actually penetrate the
aortic wall.
Heli-FX® EndoAnchor® System EN
10