ATLANTA, Dec. 3, 2025 /PRNewswire/ — MiRus is pleased to announce that patients benefiting from medical coverage through the Centers for Medicare and Medicaid Services (CMS) have been the beneficiaries of the latest technology called the EUROPA® Posterior Cervical System (PCF), based on its patented rhenium alloys, for the treatment of the cervical and upper thoracic spine. The PCF EUROPA® system had received the New Technology Additional Payment (NTAP) from CMS earlier this year.
With the cost of healthcare rising and budgets tight, hospitals are struggling to provide adequate care to the most vulnerable and those in urgent need of life-saving surgery, such as complex posterior cervical procedures. The EUROPA® PCF System received Breakthrough Device designation from the FDA, meaning it is a significantly different technology that will benefit a broader range of patients, where surgeons currently struggle with hardware prominence, skip levels, fewer biologics, quad rods and connectors, and many other compromises they make during spine surgery in the posterior cervical spine.
“This low-profile system, constructed from state-of-the-art alloys, allows me to instrument C6 and C7 without having to choose which level to skip in challenging cervicothoracic reconstructions,” said José A. Canseco, MD, PhD, assistant professor of Orthopedic Surgery at Thomas Jefferson University. “It allows me to avoid bulky four-rod constructions and cumbersome connectors, which consume valuable real estate in a highly constrained corridor. Instead, I can use a seamless 2.9mm to 4.5mm transition rod, which is particularly advantageous in complex chin-on-chest deformity cases where every millimeter matters.”
Dr. Canseco added, “I am excited to be able to bring this technology to our community at institutions like Capital Health, where there is a strong commitment to innovation and improving patient outcomes.”
“We are pleased that CMS has recognized the PCF EUROPA® system as a better option for treating complex cervical and upper thoracic spine clinical procedures by granting it NTAP designation. Hospital CEOs tell us they want broader adoption of this new technology because they can treat more patients with CMS and take advantage of CMS incentives to help hospitals offset cost pressures,” said Mahesh Krishnan, chief commercial officer.
“We continue to innovate and use MoRe® Superalloy for various applications in extremities and structural heart that will demonstrate clinical advantages and bring them to broader populations,” continued Mr. Krishnan, “this NTAP is just the beginning of many significant contributions that MiRus will make in the years to come.”
About MiRus, LLC.
MiRus is a Marietta, Georgia-based life sciences company that has developed and markets novel and patented biomaterials, implants and procedural solutions for the treatment of structural heart, orthopedic and spinal diseases. Inspired by NASA’s pioneering materials science for rocket engines, MiRus has created rhenium-based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. Learn more about MiRus at www.mirusmed.com.
Statements made in this press release that look forward-looking or that express beliefs, expectations or hopes regarding future events or anticipated results are forward-looking statements. A number of risks and uncertainties, such as risks associated with product development and commercialization efforts, the timing or expected results of any clinical trial, the ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, protection of intellectual property and competitive bidding could cause actual events to differ adversely from the expectations indicated in these forward-looking statements. The Siegel TAVR system is an investigational device and is not approved by the FDA.
Contact:
Mahesh Krishnan
Commercial Director, MiRus
mkrishnan@mirusmed.com
770-317-5564
SOURCE MiRus
