Currently more than 700 surgeons have been trained on BrainPath from over 100 institutions in 32 states across the U.S. More than 4,000 procedures have been successfully performed.
Image of access to tumor using BrainPath
Image of access to ICH using BrainPath
HOW BRAINPATH IS DIFFERENT
The BrainPath is abnormality agnostic— it is all about access. The BrainPath technology does not apply itself by abnormality type, but rather where the abnormality is located. The device provides a pathway to deep locations within the brain.
The difference from a surgical standpoint is that surgeons using BrainPath enter the brain through the sulci, the natural folds of the brain, to displace the critical structures in the white matter to reach the abnormality, thereby reducing the potential for tissue damage. This can set BrainPath apart in the field of brain surgery. Techniques with other existing tools are “trans-gyral” and require surgeons to intentionally cut through the white matter.
While existing minimally invasive approaches also use small openings, surgeons using the BrainPath are not required to cut through the brain’s white matter — tissue responsible for any number of cognitive and functional responses — to reach the target abnormality. BrainPath eases through white matter by displacing tissues like a ship’s hull displaced water. When the surgeon removes the BrainPath tool, the brain tissue can return to its previous position.
There is no other technology on the market that allows this type of minimally disruptive access through the brain – moving brain surgery in a direction much like when knee surgery moved from open surgery to arthroscopic. Today, the trauma and lengthy recovery of open knee surgery is obsolete. Other procedures deemed “minimally invasive” either risk causing trauma to the white matter of the brain during the surgery or utilize tools that emit heat upon resection of the abnormality.
The BrainPath provides minimally disruptive access to the brain abnormality by navigating through the delicate folds and fibers of the brain (see image to right). The two-piece system consists of a clear plastic sheath around a smooth, cylindrical tool with a specially designed tip. The BrainPath enters the brain through an opening smaller than a dime, allowing the surgeon to then navigate through the brain’s natural folds and fiber tracts, carefully displacing brain tissue. Once at the location of the abnormality, the surgeon removes the cylinder from the sheath, leaving the sheath in place to create a portal or narrow corridor through which the surgeon operates.
Additional FDA clearance was granted for BrainPath in July 2015 for design modifications and revised intended use. Revised intended use includes subcortical access to diseases such as primary/secondary brain tumors, vascular abnormalities/malformations, and intraventricular tumors/cysts.
WHAT THE RESULTS SHOW
The new integrated surgical approach that includes BrainPath is the focus of a growing number of professional neurosurgical organizations and national and international patient advocacy organizations. The approach is also gaining clinical credibility with increasing published evidence and data presentations, including:
17 peer-review publications
25 presentations at national and international neurosurgical conferences
Most recently, multi-center clinical results declared as “statistically significant” were granted a national podium presentation at the American Academy of Neurological Surgeons (AANS) and the International Stroke Conference (ISC). The pilot data was built around a standardized surgical approach that includes using BrainPath.
Each of these venues validates the clinical evidence of the approach and outcomes that have directly impacted the growing adoption of technologies used in the approach. Added interest and growing attendance has also been seen in training courses held throughout the year on the approach using BrainPath. Currently, more than 300 neurosurgeons have been trained using the BrainPath technology and more than 60 hospitals use the technology regularly and are designated BrainPath Centers.
BRAINPATH AND ICH
Approximately 120,000 hemorrhagic strokes occur each year in the United States. This accounts for 10-15 percent of all stroke cases. Unfortunately, almost 80 percent of patients are left physically disabled after their stroke episode.
For intracerebral hemorrhages or hemorrhagic stroke in particular, surgeons often take a watch-and-wait approach and were not being called to administer immediate treatment because it was deemed surgery would be a greater risk to the patient with little clinical benefit. However, study results for a sample of patients presented at the recent International Stroke Conferencere concluded that using BrainPath resulted in better outcomes for patients.
Hemorrhagic stroke is considered the deadliest class of stroke with an early mortality rate of 32-50 percent. The results of a multi-center study on the safety and efficacy of hematoma evacuation using a trans-sulcal surgical approach with BrainPath showed “statistically significant” improvement in patients’ neurological state associated with early intervention. This improvement was reported in 35 patients at 10 centers with 89 percent clot evacuation, as well as no new deficits or mortalities. The results were cited as a breakthrough in hemorrhagic stroke by the National Stroke Association.
No matter where the tumor, cyst or ICH is located in the brain’s white matter, chances are we can now access and remove it with the goal of greatly improving clinical and functional outcomes as measured by the standards hospitals now look at critically – reduced length of stay, improved functional recovery, and faster recovery. Neurosurgeons can now consider BrainPath a true minimally invasive option for a wide group of patients who had no surgical options before.
Pre- and Post-Op Images: ICH Evacuation Using BrainPath for Access
Related News Stories for ICH
BRAINPATH AND TUMORS
The BrainPath provides access to address primary and secondary brain tumors. One of the biggest challenges of traditional white matter surgery is access – how to reach brain tumors that are difficult to get to or located deep in the brain. In a clinical paper authored by MD Anderson, they identified the long-standing problem of traditional subcortical surgery: Subcortical Injury Is an Independent Predictor of Worsening Neurological Deficits Following Awake Craniotomy Procedures. This paper indicates a strong need for a solution like BrainPath in the marketplace.
Pre- and Post-Op Images: Tumor Removal Using BrainPath for Access
GROWING CLINICAL EVIDENCE
Collected clinical data of BrainPath procedures demonstrates the possibility that BrainPath may be used in functional neurosurgery, trauma and anywhere access is a key challenge to treatment of brain abnormalities in what is a very complex surgical environment.
WHERE BRAINPATH IS BEING USED
The BrainPath technology is currently being used in more than 60 hospitals, with over 300 surgeons currently course trained. The technology is being used in large academic centers, medium-sized and small rural hospitals, indicating an across-the-board desire to find a solution to an unmet need. Among those institutions using BrainPath as a standardized surgical approach include:
|Aurora Neuroscience Innovation Institute||Milwaukee, WI||Midwest|
|Cleveland Clinic Foundation||Cleveland, OH||Midwest|
|Indiana University Health||Indianapolis, IN||Midwest|
|St. Louis University||St. Louis, MO||Midwest|
|Washington University||St. Louis, MO||Midwest|
|Brigham & Women’s Hospital||Boston, MA||North East|
|University of Pittsburgh||Pittsburgh, PA||North East|
|Duke University||Durham, NC||South|
|Emory Healthcare||Atlanta, GA||South|
|Houston Methodist Hospital||Houston, TX||South|
|Oklahoma University||Oklahoma City, OK||South|
|Sentara Norfolk General||Norfolk, VA||South|
|UAMS (Arkansas)||Little Rock, AR||South|
|University of North Carolina||Chapel Hill, NC||South|
|Abrazo Community Health Network||Phoenix, AZ||West|
|Cedars Sinai Medical Center||Los Angeles, CA||West|
|Oregon Health – Science University||Portland, OR||West|
|Sutter Eden Medical Center||Castro Valley, CA||West|
|UC Irvine Medical Center||Orange, CA||West|
SEE BRAINPATH IN ACTION
Click below to view video of surgical procedures using BrainPath.
SUBCORTICAL SURGERY USERS GROUP
The Subcortical Surgery Group (SSG) is a group of neurosurgeons who formed a user group to support the awareness and advancement of this technique and other advanced technologies. The group, registered as a 501(c)(6), was formed to help doctors learn and become trained on the surgical approach, share experiences, and help patients find a surgeon in their area who is trained using the BrainPath integrated surgical approach.
The SSG is led by a Board and Executive Committee of 10 neurosurgeons. All are trained in using BrainPath and routinely perform BrainPath procedures. The SSG board is comprised of:
SSG BOARD OF DIRECTORS
Julian Bailes, MD
President & Chairman
Chairman, Department of Neurosurgery
NorthShore University Health System
Surgical Director, NorthShore Neurological Institute
Gary Gallia, MD, PhD
Assistant Professor of Neurosurgery & Oncology
Johns Hopkins University School of Medicine
Amin Kassam, MD
Vice President of Neurosciences
Aurora Health Care
Gustavo Pradilla, MD
Assistant Professor of Neurosurgery, Emory University School of Medicine
Chief of Neurosurgery Service, Marcus Stroke & Neuroscience Center
Grady Health System
Ronald Young II, MD
SSG EXECUTIVE COMMITTEE
Mohamed Labib, MD
Barrow Neurological Institute
Lloyd Zucker, MD, FAANS
Secretary & Treasurer
Chief of Neurosurgery, Delray Medical Center
CEO, Florida Neuroscience Institute
Partner, Brain & Spine Center South Florida
Gabriel Zada, MD
Assistant Clinical Professor of Neurosurgery
Keck Medicine of USC
A. Samy Youssef, MD, PhD
Associate Professor of Neurosurgery
University of Colorado
Rohan Ramakrishna, MD
Weill Cornell Brain and Spine Center
Kaisorn Chaichana, MD
Assistant Professor of Neurosurgery, Oncology and Otolaryngology
Johns Hopkins University School of Medicine
GET TRAINED ON BRAINPATH
The new health care model demands clinical and economic value and in surgical procedures. The BrainPath Approach course teaches a systems approach to trans-sulcal subcortical surgery in the white matter space integrating six technologies (image interpretation & trajectory planning, navigation, optics, access & cannulation, resection, and targeted therapy/neoadjuvant) for minimally invasive neurosurgery performed through small corridors. Surgeons attending the course will be introduced to each of these technologies – as well as provided opportunities for hands-on lab work using the technologies and didactics – for the purpose of creating a template or guide for selecting the surgical approach and the appropriate technology required to address lesions in a targeted manner.