Zeeland over the wire (OTW) balloon Catheters are:
- Specially designed for Percutaneous Transluminal Angioplasty (PTA)
- The catheter working length is 70, 90 and 150cm. Balloon diameters range from ø 1.5mm to ø 6.0mm, balloon work length ranges from 5mm to 200mm.
- The balloon material is made of a semi-compliant Pebax material for diameter 1.5mm to 6.0mm with a rated burst pressure of 14 atmospheres. It is a coaxial double lumen catheter with a balloon located near the distal tip.
- One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion (max. 0.014”/0.36mm).
- The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.
- The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter at specific pressure.
- All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure.
The balloon dilatation catheter is intended to dilate stenosis in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
2. Shelf Life
The shelf life is three (3) years.