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The SmartClaw™ Thrombectomy Catheter is indicated for the non-surgical removal of thrombi and emboli from the peripheral vasculature.

The SmartClaw™ Thrombectomy Catheter is a mechanical thrombectomy catheter designed to work with commercially available sheaths sized 8F or larger. The device consists of an inner catheter shaft, outer catheter shaft, heat set nitinol braid, and an actuation handle attached to the proximal ends of the shafts. There are two device configurations that differ only in length of the expandable nitinol braided basket. The two configurations are identified by the maximum diameter of the expanded basket (20 mm, 32 mm). The SmartClaw™ Thrombectomy Catheter is introduced through a commercially available sheath sized 8F or larger and delivered to the targeted vessel location under fluoroscopy and standard endovascular techniques using a commercially available guidewire. After it is delivered to the targeted vessel location, the catheter's distal nitinol basket is expanded by moving the handle slider proximally. Fluoroscopic guidance is used to ensure the expanded basket achieves a 1:1 ratio with the vessel diameter. Subsequently, the SmartClaw™ Thrombectomy Catheter is retracted proximally to pull loosened clot towards the sheath. Then, the clot is removed from the patient via aspiration or another commercially available clot removal method as appropriate for procedure requirements. After the clot is removed, the catheter's distal nitinol basket is collapsed, and the SmartClaw™ Thrombectomy Catheter is withdrawn from the targeted vessel location through the sheath.

The WOLF Thrombectomy System, 14F is indicated for: • The nonsurgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The WOLF Thrombectomy System, 14F is comprised of two single lumen variable stiffness catheters (WOLFcatheter & Devortex shaft) designed for use in removing clot from peripheral vessels. A funnel is attached to the distal end of the WOLF catheter to aid in ingestion of clot. The Devortex sleeve is attached to the Devortex shaft. When the Devortex shaft is pulled, it inqests the clot into the WOLF catheter. The WOLF catheter has hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The Devortex shaft has one radiopaque marker band at the distal marker to indicate the tip of the catheter during tracking. The WOLF catheter has one radiopaque marker band at the base of the funnel to aid in positioning the funnel relative to the sheath during clot ingestion. The WOLF Thrombectomy Sheath consists of a sheath, dilator and syringe. An active hemostatic valve is integrated at the proximal end of the sheath which can be manually opened for device introduction to provide hemostasis and minimize blood loss. The distal end of the sheath features a radiopaque marker forrecognition under fluoroscopy. The hemostasis valve is coupled with a large bore side port and is accompanied with a VacLok syringe for aspiration.

The WOLF Thrombectomy System, 6F is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature. The device is intended for single use only.

The WOLF Thrombectomy® System, 6F is comprised of two single lumen variable stiffness catheters (WOLF catheter & Devortex shaft) designed for use in removing clot from peripheral vasculature. The Devortex shaft is attached to the Devortex sleeve which when pulled, ingests the clot into the WOLF catheter. The WOLF Thrombectomy System, 6F is delivered through an access sheath that has an inner diameter of at least 0.087". Both the WOLF catheter and Devortex shaft have hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The Devortex shaft has one radiopaque marker band to indicate the tip of the catheter during tracking. The WOLF catheter has a distal radiopaque marker band toindicate its distal tip during tracking and pulling. The Devortex sleeve also has a radiopaque polymer cuff that allows for visualization of the weave movement during use.

The WOLF Thrombectomy V System is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature.

The WOLF Thrombectomy V System is comprised of two single lumen composite, variable stiffness catheters. Both devices have a distal radiopague marker for recognition under fluoroscopy. The WOLF Outer device has a collapsible braided funnel formed at its distal end. The purpose of the funnel is to enable more efficient ingestion of clot in larger vessels. The system includes a preloaded weave and additional reloadable weave and reloadable weave are fabricated from fine nitinol wire formed into a desirable tubular shape and attached to the WOLF Inner Catheter. The end of both weaves that are not attached to the WOLF Inner Catheter are cuffed with a radiopaque polymer. The WOLF outer catheter has hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The WOLF inner catheter has one radiopaque marker band at the distal marker to indicate the tip of the catheter during tracking. The outer catheter has two sets of radiopague markers. The distal most marker bands reside in the distal end of the funnel to facilitate visualization of the second marker band is located at the base of the funnel to aid in positioning the funnel relative to the sheath during clot ingestion. The reloadable weaves can be used for additional clot removal. A WOLF Thrombectomy V System used with a reloadable weave has the same principle of operation of action as the system packaged with the preloaded weave.