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The Mcdtronic Interceptor® PLUS Coronary Filter System is intended for use in saphenous vein bypass grafts, with a reference vessel diameter between 2.5 mm and 5.25mm, in conjunction with percutaneous transluminal coronary intervention (PTCI) for embolic particulate capture. The Interceptor® PLUS Coronary Filter System is intended for temporary use in conjunction with other therapeutic devices and is intended to be removed at the completion of the interventional procedure. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature

The Interceptor® PLUS Coronary Filter System (the Device) consists of six components; an 180cm extendable Steerable Vascular Filter, an Actuator Handle, a Torque Handle, a Guidewire Introducer, Peel Away Introducer and a RX Facilitator Catheter . The Steerable Vascular Filter is comprised of a radiopaque nitinol filter mounted near the distal tip of a steerable 0.014 inch nitinol hypotube guidewire. The guidewire extends 3.5cm beyond the distal end of the filter in the collapsed state to facilitate distal tracking and steering through tortuous vessels and tight lesions. The proximal end of the steerable vascular filter contains four large openings (Approximately 1400 microns for the 3.5mm filter, >1500 microns for the 4.5mm filter size and >1800 microns for the 5.5mm filter size) that allow embolic particulate to enter the filter. In addition to the Interceptor® PLUS Coronary Filter System, there is an optional Angled RX Facilitator Catheter when an alternative tip configuration is desired for filter withdrawal.

The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm - 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures. The Proxis System is also indicated to control the flow of fluids and aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction. The device is not intended to be used as a thrombectomy system.

The Proxis System (Proxis Embolic Protection System) is a proximal embolic protection system used in conjunction with other interventional devices. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli release during an interventional procedure and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter (Proxis Catheter), Inflation device, Aspiration syringe, Lip Seal and Strainer basket. In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately) may be used with Proxis System. In the stagnant flow, the guide wire is advanced across the lesion site and the interventional device is tracked over the guide wire. Upon completion of the interventional device procedure, fluid and particles from the procedure may be aspirated using the aspiration syringe. If there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to deliver saline distal to the treatment site while simultaneously applying vacuum to aspirate fluid and particles from the treatment site.

The SpiderFX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

The SpiderFX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpiderFX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a 190 cm or a convertible 320/190 cm PTFE-coated 0.014" stainless steel guidewire and a dual-ended SpiderFX Catheter for delivery and recovery.

The TriActiv FX® Embolic Protection System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0mm to 5.0m in diameter. The TriActiv FX® Embolic Protection System is intended to protect the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The TriActiv FX® Embolic Protection System is a temporary balloon occlusion embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts ranging from 3.0mm to 5.0mm in diameter. The device is comprised of four principal components: ShieldWire™ Balloon Guidewire ("balloon guidewire), ShieldWire™ Inflator ("inflator"), FX™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also four subcomponents or accessories included in the TriActiv FX® Embolic Protection the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, System: TriActiv® Flow Control Power Supply and TriActiv® Tuohy. All TriActiv FX® Embolic Protection System components are supplied sterile and for single use only with exception of the TriActiv® Flow Control Power Supply which is non-sterile and reusable. The balloon guidewire is advanced through the hospital-supplied 7F guide catheter (without sideholes) prior to percutaneous coronary intervention of a saphenous vein araft (SVG) and positioned just past the target lesion. The balloon is inflated with a medical grade carbon dioxide gas blend, creating a protected space between the quide catheter and the balloon. Once the balloon is inflated and vessel occlusion is confirmed, PTCA and/or stenting can be performed over the balloon guidewire. Immediately after intervention, the flush catheter is loaded on the balloon guidewire and advanced into the graft. With the flush catheter positioned just proximal to the balloon, the flow control delivers saline through the flush catheter to gently wash the vessel and remove any debris generated during the intervention through the guide catheter into a collection bag. The TriActiv FX® Embolic Protection System has been designed to extract at a greater rate than it infuses to prevent aortic embolization. Once the physician is satisfied with the amount of debris removed from the vessel, the protection balloon is deflated and the device is removed.

The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm – 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures. The Proxis System is also indicated to control the flow of fluids in the coronary and peripheral vasculature. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The Proxis System is a proximal embolic protection system used in conjunction with other interventional devices. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli release during an interventional procedure and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter compatible with 7F or larger guide catheters, Inflation device, Aspiration syringe, Lip Seal and Strainer basket. In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately, K023548) may be used with Proxis System. The Proxis catheter is loaded onto the guide wire and tracked down to the distal portion of the guide catheter and proximal to the lesion site. To minimize the occlusion time, the interventional devices are advanced through the Proxis catheter and positioned near the distal tip. When the sealing balloon is inflated, antegrade flow of the fluid in the target vessel is prevented. To minimize the release of embolic material, stagnation of flow is accomplished before any devices touch or cross- the lesion(s). In the stagnant flow, the guide wire is advanced across the lesion site and the interventional device is tracked over the guide wire. After the treatment, fluid and particles from the procedure are evacuated using the aspiration syringe. If there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to deliver saline distal to the treatment site while simultaneously applying vacuum to evacuate fluid and particles from the treatment site.

The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm – 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures. The Proxis System is also indicated to control the flow of fluids and aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The Proxis Embolic Protection System is used in conjunction with other percutaneous transluminal coronary angioplasty devices (PTCA). It is compatible with 8F guide catheters. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli released during a PTCA and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter, Accessory Pack (contains an inflation system, evacuation syringe and double y-adaptor) and an optional additional accessory called the Proxis Infusion Catheter (packaged separately). The Evacuation Sheath Catheter is loaded into the hemostasis valve and tracked down to the distal portion of the guide catheter. The Evacuation Sheath lines the inner lumen of the distal end of the guide catheter. When the sealing balloons are inflated, the proximal balloon seals against the guide catheter wall and the distal balloon seals against the blood vessel wall and the antegrade flow of the fluid in the target vessel is stopped. The stagnation of flow is accomplished before any devices touch or cross the lesion(s). This minimizes the distal release of embolic material. Interventional devices are passed through the evacuation sheath to the treatment site and the procedure is performed in stagnant fluid. After the procedure, fluid and particles from the procedure are evacuated using the Evacuation Syringe. The Proxis Infusion Catheter may be used to augment the retrograde flow during the evacuation by infusing saline distal to the treatment site while simultaneously applying vacuum to evacuate fluid and particles from the treatment site.

The FilterWire EZ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts. The diameter of the artery at the site of filter loop placement should be between 2.25 mm and 5.5 mm. The safety and effectiveness of this device as an embolic protection system has not been established in cerebral, carotid and peripheral vasculature or in treating native coronaries, including acute myocardial infarction.

The subject FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) consists of the same four main components as the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984. These components are: - · A Protection Wire (0.014 in. [0.36 mm] guide wire and integrated filter loop) that incorporates a circular/oval-shaped structure (filter loop assembly), which supports a thin, porous, filter membrane designed to contain and remove embolic material while maintaining blood flow. - · An EZ Delivery Sheath, a low-profile sheath that constrains the filter on the protection wire for delivery to the site of filter loop placement. It is prepackaged with the protection wire for coaxial delivery and has a slit for easy removal in a peel-away fashion. - · An EZ Retrieval Sheath is intended to negotiate through the anatomy over the protection wire to retrieve the filter. The sheath is designed to track easily to the filter without catching on obstacles such as stents. The sheath has a radiopaque marker and is silicone coated. - · A tool kit containing one peel-away introducer, one wire torquer and one hemostasis valve dilator

The SpideRX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

The SpideRX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.

The TriActiv FX® Embolic Protection System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0mm to 5.0m in diameter. The TriActiv FX® Embolic Protection System is intended to protect the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The TriActiv FX® Embolic Protection System is a temporary balloon occlusion embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts ranging from 3.0mm to 5.0mm in diameter. The device is comprised of four principal components: ShieldWire™ Balloon Guidewire ("balloon guidewire), ShieldWire™ Inflator ("inflator"), FX™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also four subcomponents or accessories included in the TriActiv FX® Embolic Protection System: the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, TriActiv® Flow Control Power Supply and TriActiv® Tuohy. All TriActiv FX® Embolic Protection System components are supplied sterile and for single use only with exception of the TriActiv® Flow Control Power Supply which is non-sterile and reusable.

The SpideRX Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

The SpideRX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.