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The BraidE Embolization Assist Device is indicated for use in the peripheral vasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked peripheral aneurysms with a neck width ≤ 10 mm. A wide-necked peripheral aneurysm defines the neck width as > 4 mm or a dome-to-neck ratio

The BraidE Embolization Assist Device is a sterile single use endovascular device intended to provide temporary assistance for the coil embolization of wide-necked peripheral aneurysms. The BraidE is comprised of a nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The braided mesh at the distal portion of the device is shown in Figure 2. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider. Because the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the aneurysm neck morphology and vessel requirement.

This document describes the regulatory acceptance of the BraidE Embolization Assist Device, leveraging data primarily from the Comaneci Embolization Assist Device due to shared design features. The core of the acceptance criteria and supporting studies are presented below:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls" section, which outlines the requirements for clinical, animal, and non-clinical performance, as well as biocompatibility and labeling. The reported device performance is extracted from the "Summary of Clinical Information" and "Summary of Nonclinical/Bench Studies" sections.

• N=63 patients (64 intracranial aneurysms) treated.
• Technical Success: 93.65% (59/63 patients) had successful coil embolization without coil entanglement, ensnarement, prolapse, or protrusion into the parent vessel. (Table 6)
• Adverse Events: 11.1% (7/63) of patients experienced a serious neurological AE within 3 months post-procedure. (Table 5) Specific AEs detailed in Table 4 (e.g., symptomatic thrombotic event, vasospasm, hemorrhage). No mortality or subject device-coil entanglements reported.
  Peripheral Case Studies (Comaneci Device):
• 6 patients with peripheral VRAAs reported across 3 publications.
• Effectiveness: All visceral aneurysms completely excluded/occluded. All but one procedure concluded with complete patency of parent and branch vessels. (Table 7)
• Safety: Generally no immediate or periprocedural complications reported, except for one case of coil entanglement leading to non-target embolization of the splenic artery. (Table 7) |
  | 2. Animal Testing: Must demonstrate device delivery to target, compatibility with coils, and evaluate adverse events (vessel/tissue damage). | Rabbit Model Study (Comaneci Device):
• Evaluated acute (4 days) and chronic (28 days) safety and performance.
• Delivery & Performance: Successful delivery and coil embolization in 23 aneurysms (20 animals). No post-procedural mortalities, no angiographically-visible coil protrusions (acute). Patent parent vessels with normal aneurysmal sac embolization (chronic).
• Adverse Events: No morbidity, thrombosis, infection, hemorrhage, or downstream ischemia (acute). Mild embolic coil protrusion in 2 Comaneci-treated aneurysms (chronic). No perforations, dissections, erosions, or thrombus formation in device contact zones. Absence of thrombus in distal skeletal muscles. |
  | 3. Non-clinical Performance Testing: Demonstrates device performs as intended, including:
  a. Mechanical testing (tensile, torsional, compressive, tip deflection forces).
  b. Mechanical testing (radial forces).
  c. Simulated use testing (delivery in tortuous vasculature, coil compatibility).
  d. Dimensional verification.
  e. Radiopacity testing. | Bench Testing (leveraged from Comaneci):
• a. Mechanical: Tensile Strength (verified compliance of joints), Kink Resistance (ability to reach tortuous vasculature), Tip Flexibility (maximum force deflected), Tracking Force/Torque (withstand typical forces/torquing). (Table 2)
• b. Radial Forces: Radial Force/Crush (withstand external forces, retain integrity, measure outward forces to ensure no serious vessel damage). (Table 2)
• c. Simulated Use: Functional and Microcatheter Compatibility (delivery in recommended microcatheter through tortuous silicone model), Simulated Use (device performance in in vitro anatomical model through femoral artery to target site). (Table 2, 4)
• d. Dimensional Verification: Verified various dimensional attributes. (Table 2)
• e. Radiopacity: Clinical study evaluated radiopacity (can be visualized under fluoroscopic guidance). |
  | 4. Biocompatibility: Patient-contacting components must be demonstrated to be biocompatible. | Biocompatibility Testing (leveraged from Comaneci):
• Classified as external communicating, limited contact (

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