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The Versus™ Catheter is indicated for: The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients. The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.

The Versus™ Pulmonary Artery Catheter is a dual-tip infusion catheter. Two lumens access and deliver physician-specified fluids, including thrombolytics, into the pulmonary arteries of each lung via a single access site. The Secondary Catheter tip telescopes independently to facilitate infusion into the contralateral lung. The device may allow for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Pressure is measured through an interface between the catheter's fluid lumen and an externally located, FDA-cleared, pressure transducer. The device may include an additional lumen that is in communication with a distal flow-directed balloon.

The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular Catheter are mechanical thrombolysis catheters indicated for the: - · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries for treatment of pulmonary embolism. - · Infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.

The BASHIRTM .035 Endovascular Catheter is a device intended for mechanical thrombolysis via expanding the distal infusion basket, allowing localized infusion of physician-specified fluids, including thrombolytics, into the peripheral or pulmonary vasculature. The distal infusion segment of the device is 12.50 cm (4.94 in.) long and consists of an expandable basket with a nitinol core surrounded by mini-infusion catheters, each with multiple infusion holes (hereafter referred to as the "infusion basket"). The infusion basket is expanded and closed using the red actuator located on the handle at the proximal end of the device. The BASHIR™ S-B .035 Endovascular Catheter is a second model intended for smaller anatomies, with an infusion basket that is 10.0 cm (3.94 in.). The devices are otherwise the same. The physician-specified fluid is then delivered via the basket infusion line located on the handle. Pulse sprays are followed by infusion through laser-drilled holes in the infusion limbs of the basket after placement in the peripheral vasculature or in the pulmonary artery. After the completion of fluid delivery, the infusion limbs are collapsed to a straight position and then the catheter is retracted into the sheath and removed from the patient. The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular catheters are composed of common biocompatible materials used in vascular catheters are mechanical and contain no electrical components and require no capital equipment.

The BASHIR™ Endovascular Catheter and BASHIR™ S-B Endovascular Catheter are mechanical thrombolysis catheters indicated for the: - · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries for treatment of pulmonary embolism. - · Infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.

The BASHIR™ Endovascular Catheter is a device intended for mechanical thrombolysis via expanding the distal infusion basket, allowing localized infusion of physician-specified fluids, including thrombolytics, into the peripheral or pulmonary vasculature. The distal infusion segment of the device is 12.50 cm (4.94 in.) long and consists of an expandable basket with a nitinol core surrounded by mini-infusion catheters, each with multiple infusion holes (hereafter referred to as the "infusion basket"). The infusion basket is expanded and closed using the red actuator located on the handle at the proximal end of the device. The BASHIR™ S-B Endovascular Catheter is a second model intended for smaller anatomies, with an infusion basket that is 10.0 cm (3.94 in.). The devices are otherwise the same. The physician-specified fluid is then delivered via the basket infusion line located on the handle. Pulse sprays are followed by infusion through laser-drilled holes in the infusion limbs of the basket after placement in the peripheral vasculature or in the pulmonary artery. After the completion of fluid delivery, the infusion limbs are collapsed to a straight position and then the catheter is retracted into the sheath and removed from the patient. The BASHIR™ Endovascular Catheter and BASHIR™ S-B Endovascular catheters are composed of common biocompatible materials used in vascular catheters are mechanical and contain no electrical components and require no capital equipment.

The EkoSonicTM Endovascular System is indicated for the: · Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis · Controlled and selective infusion of physician-specified fluids, into the pulmonary arteries and or peripheral vasculature. The EKOS+ Endovascular System is indicated for the: · Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries and/ or peripheral vasculature.

The sterile, single-use EkoSonic Endovascular Device consists of an Infusion Catheter (IC) and an Ultrasonic Core (USC). The USC fits within the central lumen of the IC. Together, they are used to deliver physician-specified fluids and ultrasound energy to the treatment zone. The sterile, single-use EKQS+ Endovascular Device consists of an Infusion Catheter (IC),and an Ultrasonic Core (USC). The USC fits within the central lumen of the IC. Together, they are used to deliver physician-specified fluids and ultrasound energy to the treatment zone.

The EkoSonic Endovascular System is indicated for the: - Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism. - Infusion of solutions into the pulmonary arteries. - Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The EkoSonic Endovascular System consists of an EkoSonic Endovascular Device and EKOS Control Unit (Control Unit 4.0 or PT-3B and Connector Interface Cables). The EkoSonic Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheters (BASHIR™+10, BASHIR™+20, BASHIR™+30, BASHIR™+40) are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.

The BASHIR™ Endovascular Catheter and the BASHIR™ Plus Endovascular Catheter are continuous flush catheters designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. There is one model of the BASHIR™ Endovascular Catheter (Ref. No. 7201) and four models of the Bashir™ Plus Endovascular Catheter, (Ref. No. 7210, 7220, 7230, 7240). The design of the catheters allow for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. The infusion can be initiated into a distal infusion basket via the Basket Port either in the non-expanded position (for vessels with smaller diameters), or by controlled expansion of the infusion basket to a desired dimension inside the vessel by the interventional specialist under fluoroscopic guidance. When the infusion basket is expanded into a clot, the clot is fragmented and a channel created, providing an opportunity for restoration of endogenous blood flow. The physician-specified solution is delivered via multiple laser-drilled holes through the infusion limbs of the catheters after placement. The BASHIR™ Plus Endovascular Catheters have a second Shaft Port, for delivery of infusion solutions into the shaft lumen adjacent to the infusion basket where multiple laserdrilled holes extend over 10 cm (BASHIR+10), 20 cm (BASHIR+20), 30 cm (BASHIR+30) or 40 cm (BASHIR+40) of shaft length. After the completion of solution delivery, the infusion limbs are collapsed to a closed position and the BASHIR™ Endovascular Catheter and/or BASHIR™ Plus Endovascular Catheter are retracted into the sheath and removed. The catheters are comprised of common materials used in vascular catheters are mechanical and contain no electrical components.

The UNIFUSE Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.

The proposed UNIFUSE Infusion System with Cooper Wire devices are single-lumen, nylon catheters with longitudinal slits located at 90° intervals around the distal end of the catheter for fluid delivery. An occluding ball wire (or occlusion guidewire) provides end-hole occlusion during fluid delivery. The catheters are available in 4F and 5F diameters and overall lengths of 90cm and 135cm. Additionally, they are available in multiple infusion segment lengths, including 2cm, 5cm, 10cm, and 15cm lengths – the latter two of which are the subject of this proposal. It is also worth noting that the overall length of each catheter remains the same no matter the length of the infusion segment. The active infusion area can be identified under imaging by means of radiopague markers on the catheter shaft at the distal and proximal ends of the infusion segment.

The EKOS PE Endovascular Device with CU 4.0 is indicated for the: - Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism. - Infusion of solutions into the pulmonary arteries. - Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The EKOS PE Endovascular System consists of an EKOS PE Endovascular Device and CU4.0 (Control Unit 4.0 and Connector Interface Cables). The EKOS PE Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 20 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

The UNI*FUSE™ Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.

The proposed UNI*FUSE™ Infusion System with Cooper Wire devices are single-lumen, nylon catheters with longitudinal slits located at 90° intervals around the distal end of the catheter for fluid delivery. An occluding ball wire (or occlusion guidewire) provides end-hole occlusion during fluid delivery. The catheters are available in 4F and 5F diameters and overall lengths of 90cm and 135cm. Additionally, they are available in multiple infusion segment lengths, including 2cm and 5cm lengths. The active infusion area can be identified under imaging by means of radiopaque markers on the catheter shaft at the distal and proximal ends of the infusion segment.