(358 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 and aid in the removal of fresh, soft emboli and thrombi 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 Embolic Protection System is used in conjunction with other percutaneous transluminal coronary angioplasty devices (PTCA). It is compatible with 8F guide catheters. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli released during a PTCA and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter, Accessory Pack (contains an inflation system, evacuation syringe and double y-adaptor) and an optional additional accessory called the Proxis Infusion Catheter (packaged separately).
The Evacuation Sheath Catheter is loaded into the hemostasis valve and tracked down to the distal portion of the guide catheter. The Evacuation Sheath lines the inner lumen of the distal end of the guide catheter. When the sealing balloons are inflated, the proximal balloon seals against the guide catheter wall and the distal balloon seals against the blood vessel wall and the antegrade flow of the fluid in the target vessel is stopped. The stagnation of flow is accomplished before any devices touch or cross the lesion(s). This minimizes the distal release of embolic material.
Interventional devices are passed through the evacuation sheath to the treatment site and the procedure is performed in stagnant fluid. After the procedure, fluid and particles from the procedure are evacuated using the Evacuation Syringe. The Proxis Infusion Catheter may be used to augment the retrograde flow during the evacuation by infusing saline distal to the treatment site while simultaneously applying vacuum to evacuate fluid and particles from the treatment site.
This document describes the Proxis System, an embolic protection device, and the study supporting its expanded indications. Here's an analysis of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the "Proximal Trial" which assessed the safety and effectiveness of the Proxis System for embolic protection. The primary acceptance criterion appears to be non-inferiority in the 30-day Major Adverse Cardiac Event (MACE) rate compared to existing distal protection devices.
| Acceptance Criteria (Non-Inferiority Margin) | Reported Device Performance (30-day MACE Rate) |
|---|---|
| Non-inferiority absolute delta: 7.0% | Test arm (Proxis): 9.2% |
| Non-inferiority relative delta: 5.5% | Control arm (Distal Protection): 10.0% |
| Upper CI of difference (Test vs. Control, ITT): 4% | |
| Upper CI of difference (Proxis vs. Distal, As-Treated): 0.3% |
Interpretation: The reported performance of the Proxis System (9.2% MACE in the test arm) and the control arm (10.0% MACE) demonstrates a difference of -0.8% (Proxis
§ 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).