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The Edwards Balloon Catheter is indicated for balloon pulmonic valvuloplasty.

The Edwards Balloon Catheter is used for balloon pulmonic valvuloplasty. The device consists of a nylon balloon, a thermoplastic elastomer (polyether block amide) multi-durometer braided shaft with 130 cm working length, platinum/iridium radio-detectable markers, and a polycarbonate y-connector that consists of a balloon inflation port and guidewire lumen. The effective length of the balloon is 4 cm and is offered in 16 mm, 20 mm, 23 mm and 25 mm diameters.

The Vida PTV Dilatation Catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following: - A patient with isolated pulmonary valve stenosis . - A patient with valvular pulmonary stenosis with other minor congenital heart . disease that does not require surgical intervention.

The Vida PTV Dilatation Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" quidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.

The Bard PTV Dilatation Catheters are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis . - A patient with valvular pulmonary stenosis with other minor congenital heart . disease that does not require surgical intervention.

The Bard PTV Dilatation Catheter is a high performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over the wire catheter is compatible with 0.035" guidewire and is available in 75 and 100 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen.

Recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis. - A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

The Mullins-X catheter is an Ultra High Pressure Dilatation catheter recommended for Percutaneous Transluminal Valvuloplasty of the Pulmonary Valve. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. One lumen is for balloon inflation and deflation. The balloons of the Mullins-X catheter are made of a non-compliant polymeric material. The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The area under the balloon is enhanced with four radiopaque platinum image bands. Two are 5mm on each side of the balloon center and two more under the balloon shoulders. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped on the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.

This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis - A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

The COEfficient PTV Catheter is a coaxial over-the-wire catheter with a balloon near the distal tip. One lumen permits guidewire insertion to facilitate advancement of the catheter into the pulmonary valve while the other lumen is for balloon inflation and deflation. The balloon of the COEfficient model is made of a non-compliant polyethylene. The balloons are designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The catheter body ends proximally in a bifurcated 'Y' connector with a guidewire port and a balloon extension. The balloon extension is marked with the product lot number and the balloon size. The outer body and inner body tubing is made of pebax. The area under the balloon is enhanced with either one or two radiopaque platinum image bands depending on the model. If marked with one image band, it is centered under the midpoint of the balloon. If it is marked with two image bands, they are located under the shoulders of the balloon. This catheter is of the same design and construction as the NuMED PTV catheters for which the 510(K) has been approved. The differences are lower profile, smaller shaft, and higher rated burst pressure.