A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal.

Overview

A multi-center, early feasibility study of using the Mechanical Tissue Resuscitation™ (MTR®) therapy system for removal of excess fluid in subjects who have had a portion of their skull removed to expose the dura/brain and require drainage for fluid removal.

Mechanical Tissue Resuscitation™ (MTR®) is intended for short-term (up to 7 days) use to externally drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy) for which a portion of the skull has been removed resulting in exposure of the dura/brain and require drainage of fluid. This is a single arm early feasibility study. The study will comprise of patients who will receive MTR® therapy to remove fluid from the surgical site in patients that have undergone a craniotomy/craniectomy. The patient population will include male and female patients ages 22-65 who have undergone a surgical procedure to remove a portion of the skull to expose the dura/brain (craniotomy or craniectomy), or a procedure in which a portion of the skull has been repaired or replaced (cranioplasty), and who, as an integral part of their care would require placement of a Jackson Pratt drain (or equivalent). The study will be conducted in subsequent phases, to enroll patients in the following populations: * Phase 1: patients undergoing elective procedures; * Phase 2: patients with mild-to-moderate TBI, as defined by a GCS of 9 or above with two reactive pupils; and * Phase 3: patients with severe TBI, as defined by a GCS of 7 or 8 with two reactive pupils. Patients will be treated with MTR® for up to seven (7) days, with a follow up evaluation approximately one month post treatment.