(184 days)
The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm – 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.
The Proxis System is also indicated to control the flow of fluids in the coronary and peripheral vasculature.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.
The Proxis System is a proximal embolic protection system used in conjunction with other interventional devices. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli release during an interventional procedure and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter compatible with 7F or larger guide catheters, Inflation device, Aspiration syringe, Lip Seal and Strainer basket. In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately, K023548) may be used with Proxis System.
The Proxis catheter is loaded onto the guide wire and tracked down to the distal portion of the guide catheter and proximal to the lesion site. To minimize the occlusion time, the interventional devices are advanced through the Proxis catheter and positioned near the distal tip. When the sealing balloon is inflated, antegrade flow of the fluid in the target vessel is prevented. To minimize the release of embolic material, stagnation of flow is accomplished before any devices touch or cross- the lesion(s).
In the stagnant flow, the guide wire is advanced across the lesion site and the interventional device is tracked over the guide wire. After the treatment, fluid and particles from the procedure are evacuated using the aspiration syringe. If there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to deliver saline distal to the treatment site while simultaneously applying vacuum to evacuate fluid and particles from the treatment site.
Here's a breakdown of the acceptance criteria and study information for the Proxis System, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets but are implicitly derived from the non-inferiority comparisons to predicate devices in terms of major adverse cardiac events (MACE). The reported device performance is presented as the MACE rates for the Proxis System compared to the control arm (using market-cleared distal protection devices). The goal was to demonstrate non-inferiority of the Proxis System.
| Acceptance Criteria (Implicit from Non-Inferiority) | Reported Device Performance (MACE) |
|---|---|
| Intent to treat (as randomized) | Test (n=294) - Proxis System: 9.2% MACE |
| (Non-inferior to control) | Control (n=300) - Distal Protection (FilterWire/GuardWire): 10.0% MACE |
| Difference: -0.8% (CI [-5.5%, 4.0%]) | |
| P-value for non-inferiority: P=0.006 (met) | |
| Per Protocol (patients who received assigned device) | Proxis (n=240): 7.1% MACE |
| (Non-inferior to distal protection) | Distal (n=236): 10.2% MACE |
| Difference: -3.1% (CI [-8.1%, 2.0%]) | |
| P-value for non-inferiority: P=0.001 (met) | |
| As treated (patients analyzed based on treatment received) | Proxis (n=241): 7.1% MACE |
| (Non-inferior to distal protection) | Distal (n=282): 11.7% MACE |
| Difference: -4.6% (CI [-9.6%, 0.3%]) | |
| P-value for non-inferiority: P |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).