Nico Corp said today it won CE Mark approval in the European Union for its BrainPath neurosurgery access device.
The BrainPath system uses a shunt and specially designed instrumentation to give surgeons access to the subcortical section of the brain.
“Gaining CE Mark approval for BrainPath is our first step in answering increasing global interest in a systems approach to subcortical brain surgery using a standardized approach. We intend to take a planned approach to global expansion and look forward to making a positive difference in the worldwide brain tumor and stroke incidence rate,” CEO Jim Pearson said in a press release.
The Indianapolis-based company touts the device as the only on the market to integrate imaging and intervention and allow for guided atraumatic access within the brain through a trans-sulcal, parafascicular surgical approach.
“Patients who undergo brain tumour surgery routinely face a significant risk of long-term damage to their brain in return for a life-saving procedure. Any development which allows neurosurgeons to access and remove tumour tissue with less potential harm to the brain is a welcome step forward. We hope the pioneering use of this technology at King’s College Hospital will lead to its wider introduction around the UK, helping to reduce the harm caused by brain tumours and their treatment – one of the key goals we are working toward at The Brain Tumour Charity,” Brain Tumour Charity chief scientific officer David Jenkinson said in a prepared statement.
“The incidence rate of diagnosed brain tumors in the United Kingdom has increased dramatically over the past four decades and is now at more than 11,000. Having just acquired this technology at our institution, we can now offer a less invasive surgical option to patients and also provide options for many who might have been told before that their tumor was inoperable. This new way to do brain surgery has a growing body of peer-reviewed evidence of improved patient outcomes for both tumor removal and hemorrhagic stroke. We’re very excited to be the first in the UK to offer this technology,” Dr. Ranjeev Bhangoo of King’s College Hospital said in a prepared statement.
The device won 510(k) clearance from the FDA in June 2015 for treating primary and secondary brain tumors, vascular abnormalities, intraventricular tumors or cysts.
