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The EXTesia Introducer Sheath Set is intended to be inserted percutaneously into a vessel to facilitate placing the interventional or diagnostic devices into a vein or artery.

The EXTesia Introducer Sheath Set is used to facilitate placing a catheter through the skin into a vein or artery. The set consists of an introducer (a sheath and a dilator) packaged together with an entry needle, guide wire, flushing syringe, and scalpel. The sheath and dilator contain a radiopaque material which makes these devices visible under fluoroscopy. In addition, the sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. EXTesia Introducer Sheath Set is packaged in a Tyvek 1073B pouch, sealed, labelled and EtO sterilized. It is for single use only. The EXTesia Introducer Sheath Set is designed for 3 years shelf life.

The guiding catheter is intended to use for introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

The Xcess guiding catheter is available in many different curve shapes and two sizes (5F and 6F). Each device consists of a catheter shaft, soft extension, soft tip, strain relief and luer. The catheter shaft is constructed with 3 layers: an outer layer of radiopaque Nylon/Pebax material, a middle layer of braided stainless steel, and an inner layer of PTFE tubing. The soft extension and soft tip consist of 2 layers: an outer layer of a radiopaque Nylon/Pebax material of differing hardness than the layer in the catheter shaft and an inner layer of PTFE. The strain relief at the proximal end of the catheter prevents kinking during catheter manipulation, and the luer is used to connect with either a hemostasis valve-linked accessory or 3-way connector. The distal ends of the guiding catheters are formed into a variety of shapes required to access differing vasculatures. The guiding catheters are provided with a hydrophilic coating on the catheter body. The guiding catheters are designed to accept a maximum of 0.038" (0.97mm) diameter guide wire.

The Vela RX PTA Balloon Dilatation Catheter is intended for use in percutaneous transluminal angioplasty (PTA) of the femoral, popliteal, infra popliteal and renal arteries.

The Vela RX PTA Balloon Dilatation Catheter has a 0.014" (0.36mm) rapid exchange co-axial design, which consists of proximal tube with hub and strain relief, transition tube, and distal tube with a balloon at the distal tip. The balloon is made of a Pebax low-compliant material and will expand to a known diameter and length at 6 atmospheres pressure. Two radiopaque markers under the balloon aid in positioning the balloon working length under the fluoroscopy. The nominal inflated balloon diameters range from 1.5mm to 4.0mm with balloon working lengths of 10mm to 40mm. The effective catheter length is 140cm, and is provided with a hydrophilic coating on the distal catheter shaft. The maximum compatible guide wire to be used with the Vela RX PTA Balloon Dilatation Catheter is 0.014" (0.36mm), and the compatible introducer sheath size is 4F.