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The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) Percutaneous Transluminal Anqioplasty (PTA) device with various shaft lengths. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold & strain relief that allows for the 0.018" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtQ) and is intended for single use only.

The UHP Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Surmodics™ Arise™ UHP Dilatation Catheter is a coaxial Over the Wire (OTW) 0.035' PTA Balloon Dilatation Catheter with a distal inflatable balloon intended to be used for the treatment of peripheral arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The UHP Dilatation Catheter obtains a low compliance at high pressure over a large working range. The proximal portion of the catheter has a bifurcated manifold which includes a balloon lumen marked "BAL" and a guidewire lumen. Two radiopaque marker bands indicate the dilatating section of the balloon and aid in the balloon placement. The catheter is designed so that a specific balloon diameter can be reached depending on the balloon size and defined pressure.

The 018 Radial Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenosis in the iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The 018 Radial Access Rx Dilatation Catheter is a co-axial rapid exchange (RX) catheter system with a semi compliant balloon at the distal end designed for use with a 0.018" guidewire. The guidewire will pass through a lumen from an RX access bond. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The balloon and catheter shaft are coated with a hydrophilic coating. The proximal end of the catheter has a single standard luer hub connector for connection of an inflation device. The inflation device is used to inflate and deflate the balloon with a contrast medium. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflated with inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The 018 Radial Access Rx Dilatation Catheter is provided sterile via ethylene oxide and is intended for single use only.

The Sublime™ Radial Access 014 RX PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenoses in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The 014 RX PTA Dilatation Catheter is a co-axial rapid exchange (RX) catheter system with a semi compliant balloon at the distal end designed for use with a 0.014" guidewire. The guidewire will pass through a lumen from an RX access bond. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The balloon and catheter shaft are coated with a hydrophilic coating. The proximal end of the catheter has a single standard luer hub connector for connection of an inflation device. The inflation device is used to inflate and deflate the balloon with a contrast medium. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflated with inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The 014 RX PTA Dilatation Catheter is to be provided sterile (via ethylene oxide, EtO) and is intended for single use only.

The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and the renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The ELM is a coaxial PTA Balloon Dilatation Catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenoses.

The WILLOW PTA Balloon Dilatation Catheter is intended to dilate stenoses in the illac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Both the WILLOW and ELM are co-axial PTA Balloon Dilatation Catheters with a distal inflatable balloon. The lumen between the inner shaft is used for inflation of the balloon with contrast medium; the inner shaft lumen permits the use of a quide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenoses. The following materials are used in the WILLOW PTA Balloon Dilatation Catheter: Nylon 11, Polyethylene, Polycarbonate, and 90% Platinum/10% Iridium. The following materials are used in the ELM PTA Balloon Dilatation Catheter: Nylon 11, Pebax, Polycarbonate, Polyethylene, and 90% Platinum/10% Iridium. All materials in both devices were tested per ISO 10993-1 and determined to be biocompatible.