Search Results

The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-35 Xeo is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. The Passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion. The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The product is also intended for injection of radiopaque contrast media for the purpose of angiography. The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents. The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

BIOTRONIK's Passeo 35 Xeo Catheter is an over-the-wire (OTW) balloon dilatation catheter, indicated for dilatation of stenotic segments in peripheral vessels. The Passeo 35 Xeo Catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo 35 Xeo Catheter towards and through the lesion(s) to be dilated. The Passeo-18 peripheral dilatation catheter is intended for dilatation of stenotic segments in peripheral vessels and arteriovenous dialysis fistulae. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter. The dilatation catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen. The dilatation catheter has a hydrophobic silicone coating on the shaft outer surface and a hydrophobic patchwork coating on the balloon. The Passeo-14 peripheral dilatation catheter is intended for the dilatation of stenotic segments in lower limb arteries. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter. The dilatation catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen. The Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system, supplied with a retractable sheath (Oscar Support Catheter), a flexible catheter (Oscar Dilator) and a PTA balloon (Oscar PTA balloon), allowing a variable guide wire support and injection of fluids, and adjustable length inflatable balloon up to 180 mm. The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with evenly spaced radiopaque markers. The Oscar Peripheral Multifunctional Catheter system is a 4F and 6F catheter system with a shaft working length of 60 cm or 120 cm, compatible with 0.014" (Oscar 4F) and 0.018" (Oscar 6F) guide wires. The device uses a semi-compliant balloon with a size dependent rated burst pressure and an indicated clinical use range of 6 atm to 16 atm. The balloon expands to a set nominal diameter (2.0, 2.5, 3.0, 4.0, 5.0, 6.0 and 7.0 mm). If required, separate PTA balloon catheters in same size range are also available separately. Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy. Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents. The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy. Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

The Sapphire NC ULTRA Coronary Dilatation Catheter is indicated for: · Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in □ patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. · Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial □ infarction. · In-stent restenosis. · Post-delivery expansion of balloon expandable coronary stents.

The Sapphire NC ULTRA Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.75mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.75mm to 4.0mm balloons have a rated burst pressure of 20 atmospheres, and 4.5mm to 5.0mm balloons have a rated burst pressure of 18 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard-length guidewire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The Sapphire ULTRA Coronary Dilatation Catheter (1.0-1.25mm configurations) is indicated for: balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purpose of improving myocardial perfusion. The Sapphire ULTRA Coronary Dilatation Catheter (1.5-4.0mm configurations) is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in . patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.

The Sapphire ULTRA Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.0mm to 4.0mm. The balloon material is made of the semi-compliant material with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability with a smooth transition to a distal shaft composed of an outer tube and an inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum marker bands are located within the balloon segment (there is only one centrally located marker band for Ø1.0-1.5mm configurations). The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 5mm length each, located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The Ringer Perfusion Balloon Catheter is indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion.

The Ringer perfusion balloon catheter is a rapid exchange catheter with a spiral-shaped inflatable balloon on the distal end and a wire lumen for delivery over a ≤ 0.014" guidewire. The inflated spiral balloon approximates a hollow cylinder. Radiopaque markers at the proximal and distal end of the balloon facilitate visualization and intravascular placement of the catheter prior to inflation. The catheter shaft has positioning marks located at 95cm (single mark) and 105cm (double mark) from the distal tip. The Ringer perfusion balloon catheter has been sterilized with ethylene oxide.

Firefighter™ NC Pro PTCA Balloon Catheter is indicated to be used for: Balloon dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; Balloon dilatation of post-delivery expansion of balloon expandable stents (models 2.00-5.00mm).

Firefighter™ NC Pro PTCA Balloon Catheter is a rapid exchange catheter, with a non-compliant balloon near the distal tip. Two radiopaque marker bands are located underneath the balloon and fixed on the inner lumen to position the balloon. The hydrophilic coating is located on the whole distal section to reduce friction and enhance the crossing capability. The effective length of the catheter is 145cm, the inner lumen of catheter permits the use of guide wire ≤ 0.014 inch (0.36mm). Firefighter™ NC Pro is available with balloon diameters of 2.00-5.50mm and balloon lengths of 6, 10, 15, 20, 25 and 30mm. 5F Guiding catheter is used for the delivery of Firefighter™ NC Pro with 2.00-4.00mm balloon diameter. 6F Guiding catheter is used for the delivery of Firefighter™ NC Pro with 4.50-5.50mm balloon diameter.

The VesPenetrator®, VesTraveler® Coronary Dilatation Balloon Catheters are indicated for: · balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction The VexPander® Coronary Dilatation Balloon Catheters are indicated for: · balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction · in-stent restenosis · post-delivery expansion of balloon expandable coronary stents

The Coronary Dilatation Balloon Catheter (VesPenetrator®, VesTraveler® and VexPander®) is a percutaneous transluminal coronary angioplasty (PTCA) is indicated for balloon dilatation of the stenotic portion of a coronary artery. Balloon diameters ranged from 1.5mm to 4.0mm. The balloon is made of Nylon material with a rated burst pressure of 16 atmospheres (atm) for both VesPenetrator and VesTraveler, and 18atm for VexPander. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube of nylon or Pebax and a tri-extrusion inner tube with a balloon welded to both tubes at the distal tip. Two radiopaque platinum marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch guidewire. The guide wire enters the catheter's tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of the brachial artery or the guide tube of the femoral artery.

The POT PTCA balloon dilatation catheter is indicated for: - balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion - balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction - balloon dilatation of a stent after implantation (balloon models Ø2.25 mm - Ø5.00 mm only) Note: Bench testing was conducted with the POT PTCA Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.

The POT PTCA balloon dilatation catheter is a sterile, flexible tube designed to be used in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible Nylon balloon at its distal tip. It is typically a rapid exchange (Rx) type with a single-lumen catheter. It is a single-use device and available in various sizes.

The SC HONK YTONK PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is a rapid exchange catheter, including a semi-compliance balloon close to the distal tip. The catheter's distal portion is dual lumen and coaxial. The dual lumen includes an outer lumen for balloon inflation, and an inner lumen to allow a ≤0.014 in (0.36 mm) quidewire to facilitate catheter advancement to and through the stenosis that is to be dilated. The proximal portion of the catheter is a single-lumen, stainless steel hypotube that includes a single luer hub for balloon inflation /deflation. The balloon design provides for an inflatable segment of both known diameter and length at recommended pressures. A balloon protective sheath placed over the balloon maintains a low profile. A mandrel is positioned inside the inner lumen to protect catheter patency. The catheter's tapered tip aids advancement to and through the stenosis. The effective length of the catheter is 145 cm. Radiopaque marker bands, in conjunction with fluoroscopy, are aid for the placement of the catheter's balloon. The 1.50 mm device size has one radiopaque marker band, while all other sizes have two radiopaque marker bands. The entire balloon has a hydrophobic coating. The shaft has a hydrophilic coating from the guidewire port to just distal of the balloon.

The NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. The NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter is also indicated for the postdelivery expansion of balloon expandable stents (bare metal and drug-eluting).

The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is a rapid exchange catheter, including a low compliance balloon close to the distal tip. The catheter's distal portion is dual lumen and coaxial. The dual lumen includes an outer lumen for balloon inflation, and an inner lumen to allow a ≤0.014 in (0.36 mm) guidewire to facilitate catheter advancement to and through the stenosis or stent that is to be dilated. The proximal portion of the catheter is a sinqle-lumen, stainless steel hypotube that includes a sinqle luer hub for balloon inflation/deflation. The balloon design provides for an inflatable segment of both known diameter and length at recommended pressures. A balloon protective sheath placed over the balloon maintains a low profile. A mandrel is positioned inside the inner lumen to protect catheter patency. The catheter's tapered tip is aids advancement to and through the stenosis or stent. The effective length of the catheter is 145 cm. Radiopaque marker bands, in conjunction with fluoroscopy, are aids for the placement of the catheter's balloon. The entire balloon has a hydrophobic coating. The shaft has a hydrophilic coating from the guidewire port to just proximal of the balloon.