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The COREPASS FLEX/CONTROL microcatheters are indicated for: · supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature (not intended for neurovasculature). · exchanging guidewires in the coronary and peripheral vasculature. · the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

The COREPASS FLEX/ CONTROL microcatheters are singe lumen catheters, offered in two shaft sizes (2.2F and 2.5F) with working lengths of 135cm or 150cm, designed for use in coronary, peripheral, and abdominal vasculature. The COREPASS FLEX/CONTROL share identical shaft profile 2.5F (0.032'') but different distal profile, including 2.2F (0.028'') for the 2.2F configuration (COREPASS FLEX) and 2.5F (0.032'') for the 2.5F configuration (COREPASS CONTROL). The catheter consists of five sections: hub with a female luer connector, catheter body shaft, proximal section, distal section, and tip. The distal most 60cm of the outer surface is coated with a hydrophilic polymer to increase lubricity and the lumen of catheter is lined with a fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014 inch (0.36mm) guidewire.

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 JADE PLUS PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for postdilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE PLUS Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters are designed for peripheral indications with Over-The-Wire (OTW) structure. The overthe-wire design permits the use of standard 0.014 inch, 0.018 inch and 0.035 inch guidewires respectively.

The Teleport XT microcatheters are indicated for: - supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature. - exchanging guidewires in the coronary and peripheral vasculature. - the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

Teleport XT Microcatheter is a single lumen OTW catheter offered in one size (2.1F, distal OD) with working lengths of 90cm, 135cm or 150cm, designed for use in the coronary and peripheral vasculature. The shaft profile gradually changes from 2.8F (0.0370") to 2.1F (0.0280"). The catheter consists of five primary sections: hub, body shaft, proximal section, distal section, and a radiopaque tip. The distal most 60cm of the outer surface is coated with hydrophilic polymer to increase lubricity and the lumen of the catheter is lined with fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014-inch (0.36mm) guidewire.

The Sapphire NC 24 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 24 Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.5mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.5mm to 3.5mm balloons have a rated burst pressure of 24 atmospheres, 3.75mm to 4.0mm balloons have a rated burst pressure of 22 atmospheres and 4.5mm to 5.0mm balloons have a rated burst pressure of 20 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 bonded to a PTFE coated stainless steel tube. The proximal shaft allows for superior pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment with the exception of 1.5mm balloon diameter which incorporate a centrally positioned single marker band. 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 marker 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 JADE PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters are designed for peripheral indications and include both Rapid Exchange (RX) and Over-The-Wire (OTW) designs. The over-the-wire design permits the use of standard 0.018 inch and 0.035 inch guidewires respectively (hereafter referred to as 18 OTW version and 35 OTW version), and the rapid exchange design permits the use of standard 0.018 inch guidewires (hereafter referred to as 18 RX version) as shown in Table 1 below. The JADE PTA balloon dilatation catheter is made of a minimally compliant material with a rated burst pressure of 16 atmospheres for 7.0mm diameters, 18 atmospheres for 4.5-6.0mm diameters and 20 atmospheres for 1.5-4.0mm diameter. Two radiopaque marker bands (Platinum/Iridium) are positioned within the balloon shoulder, and for balloons of working length 180-240mm, two more marker bands (four marker bands in total) are positioned in the middle of the balloon. A hydrophilic lubricious coating is applied to the outside surface of distal section of the catheter. A Silicone coating is applied to wire lumen surface.

The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE PTA Balloon Dilatation Catheters is now also available as an over-the-wire balloon catheter for peripheral indications. The balloon diameters range from 1.5mm to 6.0mm and balloon lengths range from 20mm to 240mm, with 90cm, 150cm and 200cm catheter lengths. The balloon material is made of a minimally compliant material with a rated burst pressure of 18 atmospheres for 5.0-6.0mm and 20atm for 1.5-4.0mm. Hydrophilic lubricious coatings are applied to the distal section of the catheter. The shaft of the catheter is composed of a proximal shaft and a distal shaft. The distal shaft is composed of a distal outer tube and tri-extrusion inner tube with a balloon welded to both tubes at the distal tip to aid in tracking through vasculature. The proximal shaft is composed of a proximal outer tube and tri-extrusion inner tube that are bonded to a female luer connector, with the proximal outer tube allowing for proximal pushability with a smooth transition to the distal shaft. The inner lumen of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the hub guidewire lumen. Two radiopaque marker bands are positioned within the balloon shoulder, and for balloons of working length 180-240mm, two more marker bands (four marker bands in total) are positioned in the middle of the balloon. One marked section, for the 90cm catheter working length, or two marked sections, for the 150cm and 200cm catheter working lengths, are located on the proximal shaft to indicate catheter position relative to the tip of the guiding catheter or introducer sheath. The Y-type hub is bonded on the proximal end of the catheter at the entrance to the inflation lumen and the guidewire lumen. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.