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The Zoom System, when used with the Zoom Aspiration Pump (or equivalent vacuum pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well.

Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.

The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 45, 4S, 35) Catheter and the Zoom 88 Large Distal Platform, the Zoom 88 Large Distal Platform Support, or the TracStar LDP Large Distal Platform to the Zoom Canister or Zoom DuoPort Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

The Zoom 4S Catheter, a new catheter within the Zoom System, is a single lumen, braid and coil reinforced, variable stiffness catheter with a radiopaque marker and a lubricious hydrophilic coating on the distal portion of the catheter. The Zoom 4S Catheter has a luer hub on the proximal end. The Zoom 4S Catheter is intended to be used in conjunction with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing and Zoom Aspiration Pump (or equivalent vacuum pump) to aspirate thrombus.

Dimensions of the Zoom 4S Catheter are included on the individual device label. The Zoom 4S Catheter is compatible with 0.035" or smaller guidewires. An additional support catheter may be used to assist in accessing the target vasculature. The Zoom 4S Catheter is compatible with guide sheaths having a minimum inner diameter of 0.071".

The Zoom 4S Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices.

The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing (Zoom POD) are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom 4S Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing and Zoom POD are made of common medical grade polymers.

In addition to the accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the Zoom 4S Catheter.

• Guidewires
• Support/Diagnostic Catheters
• Introducer Sheaths
• Aspiration Pump*
  • Capable of achieving pressure between -20inHg to max vacuum (-29 inHg)
  • Airflow rating of 0 – 23 LPM
  • IEC 60601-1 Compliant

*Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria. The Zoom Aspiration Pump is used with the Zoom Canister or Zoom DuoPort Canister.

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Telescope™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

The Telescope™ Guide Extension Catheter is a single-lumen rapid exchange catheter designed to act as an extension to a traditional guide catheter. The Telescope™ Guide Extension Catheter is intended to be used with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

The Telescope™ Guide Extension Catheter device is 150cm in length and consists of a hydrophilic-coated single-lumen distal guide segment connected to a stainless-steel polytetrafluoroethylene (PTFE) coated proximal pushwire.

The device is offered in two sizes 6F and 7F, with a hub at the proximal end of the pushwire that is used for device identification.

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The Vesalio Peripheral Catheter is intended for use in the peripheral arterial vasculature for:

• the removal of fresh, soft emboli and thrombi
• infusion of diagnostic agents, such as contrast media

The Vesalio Peripheral System consists of 1) Peripheral Catheter, 2) Peel away Introducer Sheath and 3) an Aspiration Tubing Set.

The Peripheral Catheter is a single-lumen, coil-reinforced, flexible, variable stiffness composite catheter that facilitates the removal of thrombus from the peripheral arterial vasculature when connected to a compatible aspiration pump and the Aspiration Tubing Set.

The catheter is a hollow cylindrical tube constructed using a combination of medical-grade polymers with metal reinforcement, a lubricous inner liner made from PTFE and the outer jacket consisting of thermoplastics made of polyurethane, polyether block amide, and nylon 12. The distal end of the catheter has a hydrophilic coating aimed to reduce friction and aid tracking through the vasculature. The catheter employs radiopaque characteristics for angiographic visualization.

On the proximal end, the catheter incorporates a flexible strain relief, which provides kink resistance, and a translucent, polycarbonate female luer hub to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter.

A peel-away introducer sheath is provided in the package to facilitate the insertion of the Peripheral Catheter's distal tip into an appropriate vascular sheath.

The Aspiration Tubing Set is provided in a separate package and is made of common medical grade polymers. It comprises of a hollow cylindrical tube that is bonded to a standard male rotator fitting on one end. The male rotator allows the tubing to connect to an RHV or the female luer hub of the catheter. The other end of the tubing consists of a hose fitting to enable connection with a vacuum pump. A flow switch is connected in line to provide vacuum control. The Peripheral System is provided sterile, non-pyrogenic, and is intended for single use only.

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The VersaD Delivery Catheter is intended for use with compatible guide catheters in facilitating the insertion and guidance of catheters into selected blood vessels in the neuro and peripheral vascular systems.

The VersaD™ Delivery Catheter is a single-lumen, variable stiffness catheter with a long, tapered tip delineated by radiopaque markers. The catheter has a polytetrafluoroethylene (PTFE etched liner), the proximal end has a luer hub, and the distal portion has a hydrophilic coating to reduce friction. The delivery catheter is designed specifically for use with compatible catheters.

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The Carrier XL Delivery Catheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.

The Carrier XL Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier XL Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier XL Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier XL Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.

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The Tigertriever 17 Ultra Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

The Tigertriever 17 Ultra Revascularization Device (TRPP7266) is a line extension of the existing Tigertriever 17 Revascularization Device (TRPP7166) cleared under K203592. The Tigertriever 17 Ultra Revascularization Device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. The Tigertriever 17 Ultra Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neurointerventional procedures and the treatment of ischemic stroke.

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The EMBOTRAP III Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

The EMBOTRAP™ III Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EMBOTRAP™ III Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.

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The Santreva™-ATK Endovascular Revascularization Catheter is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including Chronic Total Occlusions (CTOs), in the femoropopliteal (arterial) peripheral vasculature.

Santreva™-ATK Endovascular Revascularization Catheter ("Santreva-ATK") consists of:

1. a distal end mechanism of simultaneous plaque-puncturing, lateral plaque displacement, and plaque compression by a distal tip to form a channel,
2. an intraluminal control mechanism for intraplaque traversal of the distal tip,
3. an outer catheter shaft,
4. an inner torque cable tube with guidewire lumen, and
5. a proximal end handle with integrated torque wheel for manual rotation of the torque cable.

The handle has a luer for introduction of a guidewire through the handle and the torque cable for placement into distal true lumen after Santreva-ATK traverses and recanalizes the plaque without a wire.

The distal catheter has a rotating tip with an integrated cutting loop to puncture, displace, and compress the plaque as the mechanism of CTO crossing in combination with a centering system component to maintain the catheter in the intraluminal and intraplaque position. The centering system component has three collapsible wings and in combination with the distal tip advances into the open lumen of the vasculature and within the CTO which may facilitate formation of an intraplaque and angiographically visible channel. The collapsible centering system wings are sloped in each direction to present a tapered interface to both the CTO body plaque and to the support accessories such as guide catheters or guiding sheaths during advancement and retraction of the catheter.

After delivery of the Santreva-ATK distal catheter tip to the CTO lesion, the operator pushes the outer catheter shaft in the distal direction with one hand, while rotating the handle wheel with the other hand, such that the tip and cutting loop combination punctures the CTO cap. Continued push and rotation of the tip and cutting loop combination recanalizes the CTO plaque with simultaneous radial displacement and compression. As the operator advances the device through the CTO body, the plaque is further compressed laterally by the centering system wings, thereby crossing and recanalizing the CTO intraluminally in a controlled manner. Once the distal tip reaches and punctures the distal cap, the guidewire positioned inside the inner torque cable lumen is advanced into the distal true lumen, and the device is pulled out through the channel it formed, and through the accessories outside the body. The immediate result is a lumen gain and blood flow restoration through a channel formed by Santreva-ATK, revascularizing the previously ischemic distal zone, and allowing for a guidewire to be placed through this channel into the distal true lumen for further imaging and treatment.

Santreva-ATK has a working length of 135 cm and maximum crossing profile of 7.2 Fr (2.4 mm) with the centering system expanded.

Santreva-ATK is compatible with 6 Fr (of 0.070 inch Minimum ID) or larger guide catheters.

Santreva-ATK is also compatible with 5 Fr (of 0.070 inch Minimum ID) or larger guiding sheaths when not using a guide catheter.

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The PowerWire® 14 Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater, including vessels with stents.

PowerWire 14 Radiofrequency Guidewire is a sterile, single-use device used to deliver radiofrequency (RF) energy. It is shipped as a sterile device kit containing one (1) PowerWire 14 RF Guidewire and one (1) RFP-100A Connector Cable (separately cleared under K230571) sealed in a double compartment pouch, which is then placed inside a shelf box and then an outer cardboard box. The device is sterilized using ethylene oxide.

The device consists of a core wire surrounded by a polymer insulation. The wire connects to a radiofrequency puncture generator at the proximal end via a connector cable (K230571) and has an active tip at the distal end to deliver radiofrequency energy.

The PowerWire 14 Radiofrequency Guidewire must be used with a cleared generator such as the Baylis Radiofrequency Puncture Generator (Baylis RF Generator K122278) and connector cable such as RFP-100A Connector Cable (K230571). The connector cable connects the generator to the PowerWire 14 RF Guidewire to enable RF energy to be delivered from the Generator to the PowerWire 14 RF Guidewire.

The PowerWire 14 Radiofrequency Guidewire delivers RF energy in a monopolar mode between its distal electrode and a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) Electrode.

The PowerWire 14 Radiofrequency Guidewire is available in both a 190 cm and 300 cm length with an outside diameter of 0.014". Each length is available in both straight and angled distal configurations which provide physicians with flexibility of choosing the most suitable guidewire for accessing target tissue in tortuous pathways in the body, with either straight or angled distal tips.

Once the occlusion is crossed, the PowerWire 14 Radiofrequency Guidewire can act as a rail for balloon catheters, or can be exchanged for other guidewires or devices cleared for peripheral interventional procedures. The PowerWire 14 Radiofrequency Guidewire is designed to be compatible with balloon catheters approved for use in peripheral interventional procedures.

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The DUO Microcatheter is intended for the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

The DUO Microcatheter is a disposable, single use, sterile device. The DUO Microcatheter is a single-lumen, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 80 cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. Device dimensions and configuration are shown on the product label. A steam shaping mandrel and a peel away introducer are provided with each microcatheter.

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