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The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.

The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.

The D-KuttingTm LL Peripheral Scoring Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.

The Peripheral Scoring Balloon Dilatation Catheter is an over the wire (OTW) catheter. It features a non-compliant balloon with 3 scoring elements mounted longitudinally on its outer surface. The scoring element is attached on the surface of balloon by adhesive. The scoring elements were tightly circled by a nitinol wire and the cross section of the scoring element is a triangular. The length of the scoring element is according to effective length of balloon. The catheter has two radiopaque marker bands, which fluoroscopically indicates the expanded part of the balloon and aid in the placement of the balloon and scoring element and to facilitate proper placement. The two radiopaque marker bands are located on the inner-lumen which is underneath the balloon. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the inflation site. A lubricious coating is applied at from the distal tip to shaft tubing to enhance insertion and withdrawal performance. The inner lumen in the shaft tubing and ends in a Y-connector manifold hub with 2 Luer lock fittings. The straight manifold port is used to pass the catheter over the suitable guidewire. The second side port communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The diameter and length of the balloon and the diameter of the compatible guide wire are printed on the hub. The balloon is folded an inserted in a PTFE casing to protect the balloon and scoring element. The Peripheral Scoring Balloon Dilatation Catheter is offered in balloon diameters ranging from 2.5mm-7.0mm and lengths are from 20mm to 150mm. The catheter length is 90cm, 135cm and 150cm and is compatible with 0.014″ or 0.018″ guide wires accordingly.

Tri-Wedge PTA Scoring Balloon Dilatation Catheter is indicated to dilate stenoses in the illac, femoral, iliofemoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Tri-Wedge PTA Scoring Balloon Dilatation Catheter is an over-the-wire (OTW) peripheral balloon dilatation catheter. The catheter working length is 50cm, 75cm, 90cm and 150cm. Balloon diameters range from 3.0mm to 8.0mm. The balloon is made of a minimally compliant material with rated burst pressure of 20atm for Ø3.0-6.0mm and 16atm for Ø7.0-8.0mm. A coaxial double lumen catheter for balloon inflation and guide wire insertion is bonded to a female luer connector to form the proximal shaft. The balloon and the coaxial double lumen are welded to compose the distal of the catheter surface is coated with hydrophilic coating from the tip to the distal shaft. A scoring element with three parallel struts wraps around the balloon has radiopaque markers for positioning the balloon relative to the stenosis. The guide wire lumen is compatible with a standard 0.018-inch or 0.035-inch guide wire that enters from the catheter and extends out from the hub. The catheter is sterilized with EO and for single use only.

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring/constraining surface to the stenal in the iliac, femoral, ilio-popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is a balloon dilation scoring/constraining catheter. It consists of a metal alloy wire shaft connected to the metal alloy expandable constraining structure (CS) at the distal atraumatic tapered tip. It works with offthe-shelf compliant and semi-compliant balloons to expand the constraining structure and is designed to facilitate uniform, atraumatic balloon expansion, vessel scoring, and rewrap within small or distal vessels and arteries. The XO Constrain catheter is designed to be used with balloons between the sizes of 6 - 20mm in length and 1.5 - 4.0mm in diameter and may work with PTA and peripheral use PTCA balloon catheters with a standard over-the-wire (OTW) or rapid exchange (RX) procedural approaches. The expansion of the CS is determined by the balloon inflation diameter. Upon deflation the CS returns to its original shape and is removed from the vessel along with the balloon catheter. The XO Constrain should not be used in the coronary or neuro-vasculature.

The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.

The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.

The D Kutting™ PTA Scoring Balloon Dilatation catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

The D·Kutting™ PTA Scoring Balloon Dilatation Catheter is an Over-The-Wire (OTW) balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.018" or 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with Luer lock fillings. 3 scoring wires between the two marker bands are radially distributed every 120° and mounted on the surface of the balloon. A PVP coating is applied to the tip to enhance insertion and withdrawal performance. The D. Kutting™ PTA Scoring Balloon Dilatation Catheter will be available with balloon diameters 4.0 mm to 8.0 mm, balloon lengths 20 mm to 80 mm and with catheter lengths of 50 cm, 90 cm, and 130 cm. The diameter and length of the balloon and the diameter of the compatible guide wire are printed on the hub.

The XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive lessions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The XO Score LP (Low Profile) Percutaneous Transluminal Angioplasty Scoring Catheter is a 2.2 Fr (0.76 mm) and 3.8 Fr (1.27 mm) diameter, single-lumen, metal alloy shaft, a proximal polymer outer jacket and a balloon expandable scoring element at the distal tip. Designed to work with a standard PTA balloon catheter. The XO Score LP catheter essentially adds the lesion scoring / cutting capability to a standard PTA balloon catheter with the scoring element at its distal end. It is available in the one catheter length (150 cm), and longitudinal scoring element length (23cm).

The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, illofemoral, popliteal, infrapopliteal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with multiple embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.

The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the illac, femoral, and poplited arteries for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The Serranator® PTA Serration Balloon Catheter is an Over-The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.

The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.

The Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with three embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.