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Device Description
The V8 Transluminal BAV catheter system features a figure-8 shaped dilatation balloon
on the tip of a co-axial catheter. The catheter is inserted through a percutaneous
entry site into the common femoral artery via an introducer sheath and advanced
retrogradely to the aortic valve over a guidewire. The balloon is then inflated to dilate
the stenotic valve leaflets in an effort to increase valve opening dimensions and
systemic blood flow by improving leaflet mobility. The figure-8 shaped balloon is
intended to limit undesirable movement during inflation by locking into the patient's
anatomy, while the undersized waist segment is intended to limit excessive dilatation of
the valve annulus. Once the procedure is complete, the balloon is deflated and
removed.
The manifold port labeled "BAL" is for balloon inflation/deflation. The other manifold
port is unlabeled and used for passage of the guidewire.
Device compatibility
Guidewire: 0.035" (0.89 mm) diameter, 260 cm (or other exchange) length
Balloon Waist Size
Balloon Bulb Size
Minimum sheath
compatibility
Rated Burst Pressure (RBP): 3.0 Atm
1204-001 Revision D.1
17-23mm
22-28mm
12F
(4.0 mm)
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