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The Lotus™ Introducer Set is intended to provide femoral access to the vascular system.

The Lotus™ Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction of catheter-based devices into the vascular system. The Lotus Introducer Set will be inserted into the femoral artery using conventional minimally invasive catheterization techniques. The Lotus Introducer Set is composed of a dilator and an introducer sheath with a flush port. The design features a PTFE liner on the ID of the introducer sheath and an external coating on both the introducer sheath and the dilator. When activated, the external hydrophilic coating increases the lubricity of the surface to aid in delivery.

The EMPIRA Rx PTCA Catheter and EMPIRA NC Rx PTCA Dilatation Catheter are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The EMPIRA NC Rx PTCA Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.

The EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters, hereafter referred to as the EMPIRA Catheter, are similar in design. The catheters differ in available configurations (diameter versus balloon working length). The EMPIRA Catheter is a sterile, single-use rapid exchange catheter with a nylon-blend balloon near the distal tip. The distal section of the catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon and the inner lumen permits the use of a guide wire (≤ 0.014 in. / 0.36 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal section of the catheter is a single lumen stainless steel PTFE coated hypotube with a single luer port for the inflation of the balloon. The balloon is designed to provide an inflatable segment of specified diameter and length at recommended pressures. The balloon is folded to achieve a low crossing profile and is connected to a tapered, soft tip. The tapered tip facilitates advancement of the catheter to and through the stenosis. A hydrophilic coating is applied from the distal tip to the guide wire port and over the balloon for increased lubricity. All models have two radiopaque marker bands that aid in the placement of the catheter's balloon segment under fluoroscopy. A balloon protector is placed over the balloon to maintain a low profile and a mandrel is placed in the lumen to maintain patency. The proximal end of the catheter is comprised of a hypotube connected to a plastic hub. The hub can be connected to a standard inflation device and is used to inflate/deflate the balloon. A needle with a luer port is included for flushing the distal lumen prior to the insertion of a guide wire. The EMPIRA Catheter is compatible with standard 0.014" coronary guide wires and 5F guiding catheters. The catheter length is approximately 139 cm. The EMPIRA and EMPIRA NC Rx PTCA Catheters are offered in diameters of 1.5- 4.0 mm and 2.0-4.0, respectively. The working lengths of the treatment balloon are offered in lengths from 6.0 to 30mm. The EMPIRA and EMPIRA NC Rx PTCA Balloon Dilatation Catheter product family consists of multiple sizes.