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ATLANTA, July 31, 2024 ~ MiRus, a life sciences company based in Atlanta, Georgia, has recently announced that their EUROPA® Posterior Cervical System has received Breakthrough Device Designation from the FDA. This designation is based on the system's use of proprietary rhenium alloys and its effectiveness in treating cervical and upper thoracic spine conditions.
The EUROPA® PCF system is centered around a 2.9 mm MoRe rod, which is significantly smaller than other commercial systems currently available. This smaller diameter allows for low-profile pedicle screw tulips, resulting in less invasive surgeries and reduced hardware prominence for smaller patients. Despite its smaller size, the MoRe rod offers superior rigidity, strength, and fatigue resistance compared to other systems, reducing the risk of spine rod fractures.
Renowned orthopedic surgeon Dr. Han Jo Kim from the Hospital for Special Surgery in New York has already seen positive results using the 4.5mm MoRe rod TL system for complex cases. He believes that there is great potential in this proprietary alloy for spine surgery, as it offers implants that are not only lower profile but also more durable and stronger.
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Dr. Ankit Mehta, Associate Professor of Neurosurgery and Chief of Spine at University of Illinois Chicago, also sees promise in the EUROPA® PCF system combined with the 2.9mm MoRe rod. He notes that its ultra-low profile design allows for greater flexibility in placing implants and achieving better fixation in complicated cases. The reduced tulip volume also creates more space for fusion beds, leading to improved fusion rates in patients.
According to Jordan Bauman, VP of Regulatory and Quality at MiRus, current rates of spine implant failures and revision surgeries are still unacceptably high. However, with the EUROPA® PCF system, spine surgeons will be able to provide more durable and less invasive surgeries for their cervicothoracic patients. This is in line with MiRus' mission to offer less invasive and more durable devices for a wide range of medical conditions.
MiRus, LLC. is dedicated to transforming medicine through the development and commercialization of novel biomaterials and implants. Their goal is to make surgeries less invasive and implants safer and more durable. For more information about their products, visit www.mirusmed.com.
This press release contains forward-looking statements that express beliefs, expectations, or hopes regarding future occurrences or anticipated outcomes. These statements are based on current information available to MiRus and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these statements. MiRus does not undertake any obligation to update these forward-looking statements as new information becomes available.
The EUROPA® PCF system is centered around a 2.9 mm MoRe rod, which is significantly smaller than other commercial systems currently available. This smaller diameter allows for low-profile pedicle screw tulips, resulting in less invasive surgeries and reduced hardware prominence for smaller patients. Despite its smaller size, the MoRe rod offers superior rigidity, strength, and fatigue resistance compared to other systems, reducing the risk of spine rod fractures.
Renowned orthopedic surgeon Dr. Han Jo Kim from the Hospital for Special Surgery in New York has already seen positive results using the 4.5mm MoRe rod TL system for complex cases. He believes that there is great potential in this proprietary alloy for spine surgery, as it offers implants that are not only lower profile but also more durable and stronger.
More on Nyenta.com
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Dr. Ankit Mehta, Associate Professor of Neurosurgery and Chief of Spine at University of Illinois Chicago, also sees promise in the EUROPA® PCF system combined with the 2.9mm MoRe rod. He notes that its ultra-low profile design allows for greater flexibility in placing implants and achieving better fixation in complicated cases. The reduced tulip volume also creates more space for fusion beds, leading to improved fusion rates in patients.
According to Jordan Bauman, VP of Regulatory and Quality at MiRus, current rates of spine implant failures and revision surgeries are still unacceptably high. However, with the EUROPA® PCF system, spine surgeons will be able to provide more durable and less invasive surgeries for their cervicothoracic patients. This is in line with MiRus' mission to offer less invasive and more durable devices for a wide range of medical conditions.
MiRus, LLC. is dedicated to transforming medicine through the development and commercialization of novel biomaterials and implants. Their goal is to make surgeries less invasive and implants safer and more durable. For more information about their products, visit www.mirusmed.com.
This press release contains forward-looking statements that express beliefs, expectations, or hopes regarding future occurrences or anticipated outcomes. These statements are based on current information available to MiRus and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these statements. MiRus does not undertake any obligation to update these forward-looking statements as new information becomes available.
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