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The TightRail Guardian Motorized Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.

The TightRail Guardian Motorized Dilator Sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of: 1. Drive Assembly 2. Dilation Extension Selection (DES) Assembly 3. Motor Drive Handle 4. Outer Sheath Accessory 5. Fish Tape Accessory The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for guidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.

The device is intended for the ablation of tissue in the removal of IVC filters that have failed a previous retrieval method.

The CavaClear Laser Sheath is a 14Fr or 16 Fr laser sheath that transmits ultraviolet energy in (b)(4) pulse durations from Spectranetics' Excimer Laser generators to the tissue at the distal tip of the device. When the laser activates, a small amount of the tissue is ablated through photochemical, photothermal, and photomechanical interaction, vaporizing tissue overgrowth in order to allow for inferior vena cava (IVC) filter removal. The CavaClear Laser Sheath operates at repetition rates of 25-80Hz and fluence of 30-60mJ/mm2.

The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.

The Bridge Occlusion Balloon catheter is designed to be delivered percutaneously to the superior vena cava (SVC) for the purpose of providing occlusion of the SVC and providing emergency control of hemorrhage and perioperative occlusion in the event of an SVC tear or perforation during a lead extraction procedure. The Bridge Occlusion Balloon catheter is constructed of a compliant polyurethane balloon mounted on a dual lumen polyurethane shaft. The hub port, marked BALLOON, is connected to the balloon inflation lumen. The unmarked hub port is connected to the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. A strain relief is mounted to the catheter shaft just distal of the proximal hub. Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC prior to inflation.

Turbo-Power is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).

The Turbo-Power (2.0mm, 2.3mm) Laser Atherectomy Catheter are laser atherectomy devices designed for use with the CVX-300™ Excimer Laser System. The Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are sterile, single use, prescription only devices used for peripheral atherectomy. The Turbo-Power (2.0mm) and (2.3mm) are used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are comprised of 2 subassemblies: 1. Catheter Subassembly 2. Motor Drive Unit (MDU) Subassembly The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) guidewirecompatible lumen. The PTFE guidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system is used to photoablate multiple morphology lesions which may be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

The Turbo-Power Laser Atherectomy Catheter is indicated for laser atherectomy of de novo restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).

The 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are laser atherectomy devices designed for use with the CVX-300™ Excimer Laser System. The 2.0mm and 2.3mmTurbo-Power Laser Atherectomy Catheters are sterile, single use, prescription only devices used for peripheral atherectomy. The 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are used to ablate lesions with reference vessel diameters of ≥3.0mm. 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are comprised of 2 subassemblies: 1. Catheter Subassembly 2. Motor Drive Unit (MDU) Subassembly The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) guidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system is used to photoablate multiple morphology lesions which mav be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. The 0.014" and 0.018" Over-the-Wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Spectranetics Turbo-Elite Laser Ablation Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen for Over-the-Wire (OTW) configurations, and bundled together for Rapid-Exchange (Rx) versions. Turbo Elite Laser Ablation Catheters are available in an Over the Wire (OTW) configuration and a Rapid Exchange (RX) configuration. The Turbo-Elite laser catheters in the OTW configuration are available in six different catheter tip sizes (0.9mm, 1.4mm, 1.7mm, 2.0mm, 2.3mm, and 2.5mm) and three different guide-wire compatibilities (0.014″, 0.018″, and 0.035"). New indication clearance is only being requested for the OTW configurations of Turbo-Elite catheters compatible with 0.014" and 0.018" guidewires. The multifiber laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to an obstruction in the patient's artery. The ultraviolet energy is delivered to the laser catheter to photoablate fibrous, calcific, and atheromatous lesions, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

The Turbo-Power is indicated for laser atherectomy of de novo and restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Pecutaneous Transluminal Angioplasty (PTA).

The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a laser atherectomy device designed for use with the CVX-300™ Excimer Laser System. The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. The Turbo-Power (2.0mm) is used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) Laser Atherectomy Catheter is comprised of 2 subassemblies: - 1. Catheter Subassembly - 2. Motor Drive Unit (MDU) Subassembly The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) guidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system is used to photoablate multiple morphology lesions which mav be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

The TightRail Sub-C Rotating Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.

The TightRail Sub-C Rotating Dilator Sheaths are mechanical, intra-operative devices. The devices consist of a proximal handle drive mechanism with a distal dilation catheter. The sheaths are packaged with an optional outer support sheath. The dilator sheath is advanced, withdrawn, and rotated about the lead, catheter or foreign object to be removed. Actuating the trigger on the proximal handle activates a rotary dilation mechanism sheathed at the distal terminus of the catheter. Rotation of the inner shaft is translated to axial actuation of the dilation mechanism via a cam path contained within the distal components. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the object targeted for removal, thereby facilitating removal of said object. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Sub-C is 15.5 cm.

The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.

The Bridge Occlusion Balloon is designed to be delivered percutaneously to the superior vena cava (SVC) for the purpose of providing occlusion of the SVC and providing emergency control of hemorrhage and perioperative occlusion in the event of an SVC tear or perforation during a lead extraction procedure The Bridge Occlusion Balloon catheter is constructed of a compliant balloon mounted on a dual lumen shaft. This guidewire lumen is used to pass the catheter over a guidewire. Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC prior to inflation.

Turbo-Power™ Laser Atherectomy Catheted for laser atherectomy of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).

The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300™ Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5mm or greater in diameter. Turbo-Power Laser Atherectomy Catheter is comprised of 2 subassemblies: - 1. Catheter Subassembly - 2. Motor Drive Unit (MDU) Subassembly The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) quidewirecompatible lumen. The PTFE guidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system is used to photoablate multiple morphology lesions which mav be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.