Healthcare Industry News: FDA
News Release - May 3, 2024
Leading Academic Neurosurgeons Describe New NICO Myriad SPECTRA(TM) System as a 'Game-Changing Advancement' in Surgical Removal of High-Grade Glioma Brain Tumors
CHICAGO, May 3, 2024 -- (Healthcare Sales & Marketing Network) -- The latest product innovation by NICO Corporation is described as a "game-changing advancement" by neurosurgeons with early experience using the NICO Myriad SPECTRA System – the ONLY hand-held technology delivering blue excitation light to enhance tissue fluorescence and assist in the rapidly growing sector of fluorescence-guided surgical removal of grade III and IV glioma brain tumors."The SPECTRA was able to illuminate and provide enhanced fluorescence better than ever before to a deep tumor through a very small corridor," said Analiz Rodriguez, MD, PhD, director of Neurosurgical Oncology and associate professor in the Department of Neurosurgery at the University of Arkansas for Medical Sciences (UAMS), who used a Minimally Invasive Parafascicular Surgery (MIPS) approach with the NICO BrainPath and SPECTRA System. "Sending light deep into the brain is not easy and can make these cases extremely difficult. With SPECTRA, I could more easily see the tumor because of enhanced fluorescence. I know this will be a game changer for surgeons striving to increase extent of resection, with the intent to positively impact patient's lives."
The blue and white light from SPECTRA is mounted to NICO's resection handpiece, enabling directional light closer to the area of interest. Additionally, SPECTRA enables the unique ability for the neurosurgeon to choose intensity levels for white and blue light independently. The neurosurgeon can then easily toggle between white and blue light with no need to shift focus from the surgical field.
"The added visualization now possible when using SPECTRA is remarkable," said Ranjeev Bhangoo, MD, clinical director for Neuroscience at King's College Hospital in London. "As a supplement to our surgical microscope's blue light, we can see enhanced fluorescence that was not observable before. It's a game-changing advancement to aid fluorescence-guided surgery for high-grade glioma brain tumors."
The SPECTRA System provides illumination, resection, collection and biological preservation of tissue for the surgical removal of brain tumors and intracerebral hemorrhages using minimally invasive and open craniotomy surgical approaches. The technology is being featured at the American Association of Neurosurgical Surgeons (AANS) Annual Scientific Meeting that begins today in Chicago. Exclusive one-on-one demos using the SPECTRA System are available at the NICO Booth #825 May 3-5 by appointment here.
Grade III or IV gliomas are the most frequent and fatal type of brain tumors, with approximately 20,000 diagnoses annually1 in the U.S. and 1.2 million worldwide2. They are highly infiltrative and aggressive tumors, commonly surgically removed with the aid of fluorescene-guided agents to achieve the goal of maximal safe resection. SPECTRA helps address common challenges in fluorescence-guided procedures, such as presence of shadows created by instruments, magnification and focus settings of the microscope, and patient positioning.
"For patients undergoing the surgical resection standard of care for high-grade glioma brain tumors, our innovation offers an opportunity for improved extent of resection – a better version of the surgical gold standard of care," noted Jim Pearson, president and CEO of NICO Corporation, the worldwide leader in minimally invasive neurosurgery. "Published evidence over the last decade suggests that fluorescence-guided surgery improves extent of resection and patient outcomes, making the introduction of our SPECTRA technology particularly significant."
The SPECTRA Light Source was recently cleared by the U.S. Food and Drug Administration (FDA) and is also registered for sales and clinical use with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. Learn more about NICO technologies at NICOneuro.com; follow us on LinkedIn and Twitter, view surgical and patient videos on YouTube.
1 StatPearls. National Institute of Health, National Library of Medicine. 2024. https://www.ncbi.nlm.nih.gov/books/NBK441874/#:~:text=In%20the%20United%20States%2C%20there,the%20least%20malignant%20brain%20tumors
2 National Institute of Health, National Library of Medicine. 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10094646/#:~:text=High%2Dgrade%20gliomas%20(HGG%3B,year%20%5B1%2C2%5D
Source: NICO Corp
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