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Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial anewrysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coil is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

The Axium™ Detachable Coil and Axium™ Prime Detachable Coil (referred to collectively as "Axium™ device family"), consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Instant Detacher (I.D.) which when activated detaches the coil from the delivery pusher tip. The Instant Detacher (I.D.) is sold separately.

The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.

The Concerto Versa™ Detachable Coil is an embolization coil that consists of a platinum embolization coil attached to a composite delivery pusher, and a hand-held Instant Detacher (I.D.) which, when activated, detaches the coil from the delivery pusher tip. The Instant Detacher is an accessory sold separately and was most recently cleared in K162704. The Concerto Versa™ Detachable Coil is supplied sterile and is intended for single-use only.

1. The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset. 2. The Solitaire™ Revascularization Device is indicated 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 IV t-PA or who fail IV t-PA therapy are candidates for treatment. 3. The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ische to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

The Solitaire™ Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ Revascularization Device is intended for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends and also features radiopaque markers along the circumference of the working length of the devices are supplied sterile and are intended for single-use only.

The Marathon™ Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

The Marathon™ Flow Directed Micro Catheters are single-lumen, endhole catheters designed for the sub selective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. Microcatheter may be used with stylet, guidewire or introducer sheath to increase the rigidity of the distal section during introduction into the guiding catheter.

The Riptide™ Aspiration System is intended 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 symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Riptide™ Aspiration System is composed of the following components: 1. React™ Catheters 2. Riptide™ Large Bore Aspiration Tubing 3. Riptide™ Aspiration Pump 4. RiptideTM Collection Canister with Intermediate Tubing No changes were made to the catheters, tubing or collection canister with intermediate tubing cleared in the predicate system under K172448 and, most recently, under K183185. The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide Aspiration System. The vacuum pressure of the Riptide Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

1. The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ische to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset. 2. The Solitaire™ Revascularization Device is indicated 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 IV t-PA or who fail IV t-PA therapy are candidates for treatment. 3. The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ische to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

The Solitaire™ Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion in the neurovasculature such as the Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The Solitaire™ Platinum Revascularization Device also features radiopaque markers along the circumference of the working length of the devices are supplied sterile and intended for single-use only.

1. The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset. 2. The Solitaire™ Revascularization Device is indicated 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 IV t-PA or who fail IV t-PA therapy are candidates for treatment.

The Solitaire™ 4 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 4 Revascularization Device is designed for use in the neurovasculature such as the Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ 4 Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The Solitaire™ 4 Revascularization Device also features radiopaque markers along the circumference of the working length of the device. The devices are supplied sterile and are intended for single-use only.

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute iscoke 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 symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Riptide™ Large Bore Aspiration Tubing is provided sterile and intended for single-use. The Riptide™ Large Bore Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the catheter. The Riptide™ Large Bore Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Large Bore Aspiration Tubing is connected to the Riptide™ Canister (outside of the sterile environment) while the distal end of the Riptide™ Large Bore Aspiration Tubing is connected to the catheter (inside the sterile environment). The Riptide™ Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing. The Riptide™ Large Bore Aspiration Tubing is designed to allow the user to control the application via an in-line flow switch.