PFM Medical Nit-Occlud Le VSD Mode D'emploi page 11

❹
Insertion of the System
• F ollowing confirmation of correct positioning of the
long sheath in the ascending aorta or left-ventricular
outflow tract (LVOT), remove the dilator in the long
sheath and the guide wire splint.
• ( Fig. 10) Slowly advance the implantation catheter and
fitted coil from the transvenous access into the long
sheath and into the ascending aorta, under fluoroscopic
monitoring.
• A dvance the implantation catheter and fitted coil to
approx. 10 mm beyond the tip of the long sheath.
bp = baseline point
M1 = four windings outside the implantation catheter
M2 = o nly two windings remain within the implantation
catheter
M3 = whole of coil outside implantation catheter
❺
Coil Configuration
• ( Fig. 10) Under fluoroscopic and echocardiographic monitoring (TOE or TTE), push the Nit-Occlud® Lê VSD coil out
from the implantation catheter, using the metal cannula and single-hand control, until the first four windings have
been released. A further check on the number of windings released is provided by the markings (Fig. 11). For this pur-
pose, carefully advance the one hand implantation device until it enters the valve of the Y-connector. The entrance
point of the one hand implantation device is now also the baseline point (bp) for the markings (M1–M3) on the delivery
system. If the M1 marking is at the baseline point (bp), this means that four windings have been released.
(In some cases, it may be preferable for more than four windings to be released in the aorta, according to aortic size
parameters. Thus, the coil configuration can be assessed when the coil is already in the aorta. This procedure should
be carried out only by a medical practitioner having extensive experience with the product, since the coil can become
caught up as it passes through the aortic valve.)
• ( Fig. 12) Then, carefully pull the complete system, in-
cluding the long sheath, back via the aortic valve to
the left-ventricular outflow tract. Continue pulling so
that the coil enters the defect, where it will begin au-
tomatically adapting to the defect contours. The sheath
and implantation catheter remain in the same position
relative to one another.
GA053/Rev02_2019-04-18
Fig. 10: Coil configuration
Fig. 11: markings (M1–M3) on the delivery system
Fig. 12: Final coil configuration
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