1. The document describes the novel NHancer ProX NX3 microcatheter and its hybrid locking mechanism, which allows the microcatheter shaft to lock onto a guidewire for increased penetration power and precision.
2. In vitro testing found the hybrid locking can increase guidewire penetration power up to 10x for soft wires and 3x for stiff wires when puncturing proximal caps. It also allows precise shaping of the guidewire tip when the tip extends beyond the microcatheter by 2-6mm.
3. The hybrid locking, called the "rotational lock-cross technique", helps the microcatheter cross lesions when regular attempts fail, as demonstrated in a study showing crossing in 22 of 92 CTO
2. " Antegrade and retrograde experience with
the novel NHancer ProX NX3 microcatheter"
3. 1Wilson. S, Maeremans. J.Walsh. S, Hanrattu. C, Gesser, M.M, Dens. J, Christiansen. E, Bufe. A, spratt. J; The first clnical experience with a novel “locking”microcatheter in chronic coronary total occlusion. Eurointervention 2017;12:e1-e6
5. Hybrid Locking
• The shaft locking device can be placed at any position on the shaft when a guidewire is in place.
• When the locking device is engaged, the shaft of the NX3 is compressed and the micro catheter becomes
one device with the guidewire.
• When unlocked, the shaft will decompress without any degradation of the shaft integrity.
Guidewire NX3 “locked” onto guidewire
6. Potential applications for the hybrid locking:
1. Increase guidewire penetration power to puncture proximal cap
2. “Surgical” precision of guidewire shape/ direction
3. ProX NX3 catheter lesion crossing
7. Increase guidewire penetration power
to puncture proximal cap
In-vitro proximal cap penetration by guidewire only vs. hybrid locking demonstrates :
• Up to10x more penetration power for soft wires
• Up to 3x more penetration for stiff wires.
8. “Surgical” precision of guidewire shape/ direction
Typical guidewire shape
5mm
Hight 2.3 (mm)
tip to tip > 1 cm
tip to tip ~ 4 mm
tip to tip ~ 2 mm
All illustrations are to scale. Vessel is 2.5 (mm)
Equivalent guidewire penetration force for
Fielder XT and Miracle Bros 12 guidewires
when hybrid shaft locking used with
between 2-6 mm guidewire tip extension
from the ProX NX3 tip1.
With hybrid shaft locking, the shape of the guidewire
can be modified “live-on-angio” when the tip of the
ProX NX3 is less than 5mm from the distal end of the
guide wire.
2.3mm
1Data on file at IMDS
9. NX3 catheter lesion crossing
If the NX3 is not crossing the lesion by a regular attempt, hybrid locking will increase
the chance of lesion crossing significantly.
• In-vitro testing of the current NX3 demonstrates much higher lesion penetration
power (see movie included)
• A multi-centre study, led by Dr. James Spratt, with the original Pro X version in
2015(in 92 unselected CTO cases) demonstrated micro catheter crossing after
initial failure in 22 cases. (EuroIntervention paper).
• The locking/push can be accompanied by slow rotational drilling.
The technique of hybrid locking for NX3 catheter crossing is called
“Rotational lock-cross technique”
10. Hybrid locking safety
• In the multi-centre study led by Dr. James Spratt, the overall complication rate was 1.1%
with no major events.
• No adverse events reports have been made to IMDS in relation to the use of the hybrid
locking.
