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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 Size
17-23mm
Minimum sheath
12F
compatibility
(4.0 mm)
Rated Burst Pressure (RBP): 3.0 Atm
1204-001 Revision C.1
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