DENVER, CO - Indianapolis-based medical device maker NICO Corporation announced today at the American Association of Neurological Society (AANS) annual meeting that it has received CE Mark approval for its automated minimally invasive brain tumor removal device, the NICO Myriad. The approval allows NICO to sell the Myriad system in the 27 countries that make up the European Union. The device has been commercially available in the United States since 2009 with more than 1,000 procedures performed with adults and children, sometimes in cases that would have previously been considered inoperable.
"The CE Mark approval for the Myriad in Europe is a significant accomplishment that validates the impressive clinical and patient results that have been achieved throughout the U.S.," said Jim Pearson, president and CEO of NICO Corporation. "This device is pushing the frontier of progressing minimally invasive neurosurgery. The Myriad is allowing neurosurgeons to advance corridor surgery by providing improved access to tumors and shortening surgical resection times that result in shorter patient recovery times and hospital length of stays. It can provide the opportunity to significantly reduce patient trauma by reaching tumors located deep within the brain through much smaller openings."
The Myriad is about the size of a pencil and is completely automated, making it the first device that operates in open and endoscopic surgical approaches without using a heat source or ultrasonic energy that can potentially damage delicate critical structures in the brain. Its slender design and malleable tip allow surgeons to operate through narrow surgical corridors to aggressively remove large masses or highly fibrotic tissue, or work with precision to remove difficult to reach tumors that may be located near or on top of structures like optic nerves and carotid arteries.
The Myriad is also able to collect tissue removed during the surgical process in a viable (intact) format. This is significant because it can be sent for pathological and oncological evaluation to determine post-surgical therapeutic treatment regimens that improve patient outcomes.
Neurosurgeons use a variety of tumor removal tools, including manual instruments to perform tedious and complicated brain surgeries that require methodical removal of tissue in small amounts. In these instances, tools are moved in and out of the surgical field numerous times over several hours. The Myriad is an automated multi-functional tool that acts as scissors, suction, dissector and probe - giving surgeons the ability to minimize movement in and out of the surgery site and operate more efficiently and effectively to deliver better patient outcomes. The device is compatible with all endoscopes and microscopes that use cameras to see tumors deep in the brain or are inserted through the nose to reach tumors with no need for an incision.
More than 200,000 people in the United States and 2 million people worldwide are diagnosed with a brain tumor every year. They are the leading cause of solid tumor cancer deaths in children under the age of 20, the second leading cause of cancer deaths in male adults ages 20-29, and the fifth leading cause of cancer deaths in females ages 20-29. To learn more about NICO Corporation and the NICO Myriad product line, visit www.niconeuro.com.