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The NeVa PV Thrombectomy Device is indicated for:

• The non-surgical removal of thrombus burden from coronary blood vessels,
• Use with adjunctive aspiration and with the injection or infusion of contrast media and other fluids.

The NeVa PV Thrombectomy Device ("NeVa") is a mechanical thrombectomy device that is temporarily inserted into the coronary vasculature under angiographic visualization in order to remove emboli and thrombus to restore blood flow to occluded vessels. The overall design of NeVa is similar to other commercially mechanical thrombectomy devices that use a self-expanding nitinol basket attached to a core pusher wire. To optimize emboli and thrombus removal, NeVa employs a capture cell design within the nitinol basket structure that incorporates a proprietary drop zone pattern. This proprietary drop zone design maximizes clot retrieval efficiency without changing the mechanism of action used by mechanical thrombectomy devices. As with other mechanical thrombectomy devices, NeVa is intended to be delivered through a compatible commercially available microcatheter to the target vessel. NeVa is intended to be retrieved into a guiding catheter with adjunctive aspiration to reduce potential emboli. NeVa is provided sterile and intended for single-use only. To accommodate different vessel diameters and clot sizes, NeVa is provided in multiple expandable tip sizes and configurations.

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NeVasc Aspiration Catheter:
As part of the NeVasc Aspiration System, the NeVasc Aspiration Catheter with the Vesalio Aspiration Tubing Set and a compatible aspiration 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 symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

Vesalio Aspiration Tubing Set:
As part of the NeVasc Aspiration System, the Vesalio Aspiration Tubing Set is indicated to connect the NeVasc Aspiration Catheter to a compatible aspiration pump.

The NeVasc Aspiration System consists of 1) NeVasc Aspiration Catheter, 2) Peel Away Introducer Sheath and 3) Vesalio Aspiration Tubing Set.

The NeVasc Aspiration Catheter is a single-lumen, reinforced, flexible, variable stiffness composite catheter that facilitates the removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Vesalio Aspiration Tubing Set. The catheter distal shaft has an external hydrophilic coating aimed at reducing friction during use. The distal end of the catheter shaft is radiopaque for fluoroscopic visualization, and the proximal end contains a luer hub that allows attachment of accessories for flushing and aspiration.

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

The Vesalio 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 a rotating hemostasis valve (RHV) or the female luer hub of the NeVasc Aspiration Catheter. The other end of the tubing consists of a hose fitting to enable connection with an aspiration pump. A flow switch is connected in line to provide vacuum control.

The NeVasc Aspiration System is provided sterile, non-pyrogenic, and is intended for single use only.

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