217171 - ITQ - PHSA-15149 Neurosurgical Consumables, Implants and Accessories

The scope of this ITQ includes specific, highly specialized medical products for brain aneurysm clipping, products for CSF and hematoma management in a neurocritical care setting, and neurosurgical accessories, including but not limited to products for intraoperative cranial stabilization. Below is a brief overview of the clinical scope for each category:

• Category 1. This category encompasses products used in open surgical procedures to repair aneurysms or arteriovenous malformations in the brain. These include temporary and permanent aneurysm clips, specialized instruments for their application and removal, as well as neurovascular dopplers to restore anatomical blood flow in the brain.
• Category 2. This category encompasses products used in the safe medical management of intracranial pressure (ICP) including but not limited to temporary closed drainage systems (Ventricular and lumbar drains), consumables for ICP monitoring, hematoma evacuation systems and permanent implants (shunt system components: inflow and outflow catheters, valves (fixed and adjustable), reservoirs, etc.) for chronic hydrocephalus.
• Category 3. Neurosurgical Accessories: products to support neurosurgical cranial stabilization (skull clamps, headrests), and cranial access products (including scalp clips/appliers, cranial perforators, and single-use cranial drills).