Search Results

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.

N/A

Ask a specific question about this device

The NeVa™ PV Thrombectomy Device is indicated for:

• The non-surgical removal of emboli and thrombi from peripheral blood vessels.
• Temporary use in peripheral vessel occlusion.
• Use with aspiration and with the injection or infusion of contrast media and other fluids.

The NeVa™ PV Thrombectomy Device is a sterile, single-use thrombectomy device designed to for use in the peripheral vasculature to restore blood flow via non-surgical removal of emboli and thrombi from peripheral vessels in the vasculature. The NeVa™ PV device consists of a self-expanding nitinol basket attached to a core pusher wire that can be delivered through a micro catheter, deployed across a clot, and then removed with the clot to enable revascularization of the occluded vessel. To aid in fluoroscopic visualization, radiopaque markers are positioned at the distal end, proximal end, and along the nitinol basket of the NeVa™ PV device. A flexible atraumatic soft tip attached to the distal end of the nitinol basket is radiopaque for enhanced fluoroscopic visualization.

The NeVaTM PV device is provided sterile and is intended for single patient use. The device is not intended to be re-sterilized or re-used. No accessories are provided with the NeVaTM PV device. The device is intended to be used in conjunction with the appropriately sized microcatheter as indicated in the proposed Instructions for Use.

The provided text describes the regulatory clearance of a medical device, the NeVa™ PV Thrombectomy Device, based on its substantial equivalence to a predicate device. It details the device's characteristics, indications for use, and a summary of nonclinical testing performed to demonstrate its performance. However, the document does not contain information about acceptance criteria for a study, nor does it detail a study that proves the device meets specific acceptance criteria in the context of an algorithm or AI performance.

The document is for a medical device clearance (510(k)) that relies on substantial equivalence to a predicate device (ReVive™ PV Thrombectomy Device), not on meeting specific quantitative performance metrics as one might see for an AI/algorithm-based medical device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of AI/algorithm evaluation. The document focuses on the physical and functional performance of a mechanical thrombectomy device.

To directly address your request given the provided text, I must state that the information is not present in the provided regulatory submission.

Ask a specific question about this device