RegulatorySpine

First System for Dynamic Intra-operative Measurement of Segmental and Global Spine Alignment Receives FDA Clearance

ATLANTA, July 22, 2019 /PRNewswire/ — MiRus is pleased to announce FDA 510(k) clearance of the GALILEO™ Spine Alignment Monitoring System, a non-optical, wireless, real-time measurement system for segmental and global sagittal spine alignment. The GALILEO™ Spine Alignment Monitoring System received the 2018 Spine Technology Award at the NASS meeting for excellence and innovation in spine surgery navigation.

Eric Nottmeier, MD Neurosurgeon in Jacksonville, Florida stated “sagittal malalignment has been shown to directly impact the quality of life and function of patients. This innovative product will provide surgeons with much-needed real-time feedback for achieving optimal sagittal alignment in the OR.”

“Achieving spinal alignment correction in spinal deformity surgery is particularly challenging. For the first time, surgeons can now receive dynamic feedback as they perform corrective procedures and confirm that the planned sagittal alignment has been achieved,” said Thomas Morrison, MD, neurosurgeon at Polaris Spine & Neurosurgery, Atlanta, Ga. 

Angad Singh, VP Robotics and Surgical Navigation commented “Given the increased attention to sagittal plane alignment in recent years, we are pleased to offer the first and only FDA-approved product that intraoperatively measures this important clinical parameter in real-time without reliance on repeated imaging. The product is also an example of the kind of dynamic tracking and feedback we will be incorporating into our robotics platform.”

About MiRus, LLC.

MiRus is a medical device company that has developed and is commercializing proprietary novel biomaterials, implants and software solutions for spine, orthopaedics and cardiovascular disease.  We are addressing the demands of today’s healthcare environment with an integrated platform of pre-operative planning and risk assessment tools, a breakthrough navigation and robotics system and post-operative monitoring and risk mitigation. Find more information about MiRus at www.mirusmed.com.

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

GALILEO™ and MiRus™ are trademarks of MiRus, LLC.

Contact:  
Mahesh Krishnan  
VP, Sales and Marketing, MiRus  
mkrishnan@mirusmed.com  
770-317-5564

SOURCE MiRus

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Chris J. Stewart

Chris currently serves as Chief Operating Officer at Ortho Spine Partners. Prior to that, he was the assistant vice president and business unit leader of Medical Device Management for HealthTrust.

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