Excipio® SV Thrombectomy Device

Indications, Safety, & Warnings

The Excipio SV Thrombectomy Device is cleared for sale in the USA. Caution: Federal (or United States) law restricts this device to sale by or on the order of a physician.

Return to Product Page >>

Indications for Use

The Excipio SV Thrombectomy Device is indicated for the non-surgical removal of soft emboli and thrombi from peripheral blood vessels.

Contraindications

    • Not for use in the coronaries or the neuro-vasculature.
    • Do not use on patients with known hypersensitivity to nickel-titanium.

Warnings

    • Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with interventional procedures should use this device.
    • The appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure at a dosage deemed appropriate by the physician.
    • The device is intended for single use only. Do not attempt to re-sterilize or reuse, as this can result in compromised device performance.
    • Use before the “Use by” date on the packaging.
    • Do not advance, retract, or use any component of the Excipio SV Thrombectomy Device against resistance without careful assessment of the cause using fluoroscopy. Torquing, forced insertion, or forced removal of the Device may result in damage to the device or the vessel.
    • Do not attempt to advance or retract the thrombectomy device through the aspiration catheters unless the basket is fully closed. The thrombectomy device should always be used over a 0.014” guidewire.
    • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Precautions

    • Do not use if the sterile package is compromised or if the device is damaged. Do not use or attempt to straighten a shaft that is kinked. Prepare a new catheter.
    • The Excipio SV Thrombectomy Device should be manipulated in the vessel only while using high-quality fluoroscopy.
    • Before use, the catheter should be examined to verify that the basket opens and closes properly and ensure that its labeled size and shape are suitable for the procedure for which it is to be used.

Adverse Effects

Complications may occur at any time during or after the procedure. Possible complications include, but are not limited to the following:

    • Access site complications
    • Allergic reaction
    • Arterial dissection
    • Arterial thrombosis
    • Death
    • Distal embolization of blood clots and atherosclerotic plaque
    • Hematoma
    • Hemorrhage
    • Ischemia
    • Infection
    • Perforation and/or vessel rupture
    • Tip separation and distal embolization
    • Vasospasm

Excipio® LV Thrombectomy Device

Indications, Safety, & Warnings

The Excipio LV Thrombectomy Device is cleared for sale in the USA. Caution: Federal (or United States) law restricts this device to sale by or on the order of a physician.

Return to Product Page >>

Indications for Use

The Excipio LV Thrombectomy Device is indicated for the nonsurgical removal of emboli and thrombi from peripheral blood vessels.

Contraindications

    • Not intended for use in the coronary arteries, pulmonary vasculature or neurovasculature.
    • Do not use on patients with known hypersensitivity to nickel-titanium.

Warnings

    • Only physicians who have received appropriate training in interventional techniques and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with interventional procedures should use this Device.
    • The appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure at a dosage deemed appropriate by the physician.
    • Do not advance, retract, or use any component of the Device against resistance without careful assessment of the cause using fluoroscopy. Torquing, forced insertion, or forced removal of the Device may result in damage to the Device and/or the vessel.
    • The Device should be used with a compatible aspiration catheter/sheath.
    • Do not attempt to advance or retract the Device through the aspiration catheter/sheath unless the basket is fully closed.

Precautions

    • Do not use if the sterile package is compromised or if the Device is damaged. Do not use or attempt to straighten a shaft that is kinked. Prepare a new Device.
    • Before use, ensure that the product labeled size and shape are suitable for the procedure for which it is to be used.
    • Use before the “Use By” date on the packaging.
    • The Device should be manipulated in the vessel only in conjunction with fluoroscopic visualization.

Adverse Effects

Possible complications include, but are not limited to the following:

    • Access site complications
    • Acute occlusion
    • Allergic reaction
    • Arrythmia
    • Anemia
    • Death
    • Hematoma or hemorrhage at access site
    • Hemorrhage
    • Hypotension
    • Inability to completely remove thrombus
    • Intimal disruption
    • Ischemia
    • Infection
    • Renal impairment or acute renal failure from contrast media
    • Thromboembolic events
    • Tip separation and distal embolization
    • Vessel spasm, thrombosis, dissection, or perforation