Device Dossier

BrainPath Approach Procedure Pack - Surgical procedure kit, neurosurgical, single-use, non-medicated

Device Dossier for BrainPath Approach Procedure Pack - Surgical procedure kit, neurosurgical, single-use, non-medicated (Surgical procedure kit,…

Intended purpose

The procedure pack consists of a handpiece, sheath, and shepherd’s hook. The handpiece is intended for the resection of soft tissue abnormalities found in the central nervous system as determined appropriate by the surgeon. The sheath and shepherd’s hook are intended to provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following: - Primary/Secondary brain tumors - Vascular abnormalities/malformations - Intraventricular tumors/cysts

Functional description

Handpiece provides controlled resection in two modes 1) suction-only and 2) suction-with-cutting. Variable suction is delivered to the aperture to pull tissue in and slice via scissoring-action of the reciprocating inner-cannula. The sheath is paired with a reusable obturator. (Obturator sold separately.) The obturator is removed once the desired location is reached leaving the sheath as a corridor for access. The shepherd’s hook is a securing option the sheath.

TGA Public Summary