Houston, Texas - Millar, Inc. is pleased to announce the expansion of the FDA 510(k) clearance for its Mikro-Cath™ Pressure Catheter for use in monitoring intra-compartmental and airway pressures. This expanded 510(k) adds to the Mikro-Cath’s previous clearance for use in cardiovascular pressure monitoring and provides greater access to Millar’s proven MEMS pressure sensor for medical providers and researchers dedicated to improving clinical outcomes in orthopedics and otolaryngology.
The Millar Mikro-Cath provides the advantage of acquiring high-fidelity data that is unaffected by patient position or movement, allowing for accuracy and ease of use during exercise studies for compartment pressure measurements. Accurate measurements are important for diagnosing compartment syndrome that can result in tissue perfusion and dysfunction of neural and muscular structures within the compartment. The flexibility of the catheter also allows for ease of insertion during airway pressure measurements during sleep studies.
“By expanding our 510(k), we will continue to provide the highest quality and most reliable pressure measurements to clinicians and researchers by increasing access to Millar’s MEMS sensor for use in two new markets, both of which will benefit from the greater accuracy and increased ease of use provided by the Millar sensor,” says Tim Daugherty, President and CEO.
Over Millar’s 45 plus year history, its MEMS sensor-enabled catheters have delivered the most reliable measurement of physiologic pressures. They have been referenced in thousands of medical and science journal articles, citing where Millar devices have been used to advance medical research in cardiovascular, urodynamic, neurosurgical care and orthopedic applications.
The announcement is the latest example of Millar’s ongoing strategic shift to provide greater access to its MEMS technology for a broader patient population and, in turn, more opportunities for medical device partnerships and advanced scientific research.