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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 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 Bashir™ Plus Endovascular Catheters are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The Bashir™ Plus Endovascular Catheter is a continuous flush catheter designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. There are four models of the Bashir™ Plus Endovascular Catheter, (Ref. No. 7210, 7220, 7230, 7240). The design of the Bashir™ Plus Endovascular Catheter allows for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. Depending on the target location, 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. The physician-specified solution is delivered via multiple laserdrilled holes through the infusion limbs of the Bashir™ Plus Endovascular Catheter after placement. The Bashir™ Plus Endovascular Catheter has a second Shaft Port, for delivery of infusion solutions into the shaft lumen where multiple laser-drilled holes cover 10 cm of length (Ref. No. 7210), 20 cm (Ref. No. 7220), 30 cm (Ref. No. 7230) or 40 cm (Ref. No. 7240). After the completion of solution delivery, the infusion limbs are collapsed to a straight position and then the Bashir™ Plus Endovascular Catheter is retracted into the sheath and removed. The Bashir™ Plus Endovascular Catheter is comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.

The Bashir™ S-B Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The Bashir™ S-B Endovascular Catheter (Model 7101) is a continuous flush catheter designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. The design of the Bashir™ S-B Endovascular Catheter allows for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. Depending on the target location, the infusion can be initiated 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. The physician-specified solution is delivered via multiple laser-drilled holes through the infusion limbs of the Bashir™ S-B Endovascular Catheter after placement. After the completion of solution delivery, the infusion limbs are collapsed to a straight position and then the Bashir™ S-B Endovascular Catheter is retracted into the sheath and removed. The Bashir™ S-B Endovascular Catheter is comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.

Bashir™ Endovascular Catheter: The Bashir™ Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. Bashir™ N-X Endovascular Catheter: The Bashir™ N-X Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids into the peripheral and pulmonary artery vasculature.

Thrombolex developed the Bashir™ Endovascular Catheter (Model 7201) to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. The Bashir™ N-X Endovascular Catheter (Model 7200) is a second model developed for infusion of physician-specified fluids in the pulmonary artery. The Bashir™ N-X differs from the Bashir™ Endovascular Catheter in that the infusion limbs do not expand into an infusion basket but remain collapsed in a straight configuration. The two device models have a different appearance, namely in the handle design and color, which ensures appropriate use and identification. The design of the Bashir™ Endovascular Catheter allows for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. Depending on the target location, the infusion can be initiated 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. The physician-specified solution is then delivered via multiple laser-drilled holes through the infusion limbs of the Bashir™ Endovascular Catheter. After the completion of solution delivery, the infusion limbs are collapsed to a straight position in the case of peripheral vasculature, and then the Bashir™ Endovascular Catheter is retracted into the sheath and removed. The handle of the Bashir™ N-X Endovascular Catheter has been modified to disable expansion of the basket. The Bashir™ N-X Endovascular Catheter, unexpanded, is thus similar to other straight infusion catheters including the predicate device. Delivery of the Bashir N-X™ Endovascular Catheter into the pulmonary artery is accomplished using a long guide sheath using standard interventional techniques. The Bashir™ Endovascular Catheter is placed over a guidewire inside the sheath to the desired location under fluoroscopic guidance. The catheter does not come in direct contact with the right atrium, tricuspid valve, right ventricle or pulmonic valve at any time, as it is within a guide sheath. The Bashir™ Endovascular Catheter and Bashir™ N-X Endovascular Catheter are comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.