The Mikro-Cath had been previously approved for cardiovascular pressure measurements in Europe and received FDA clearance in March 2017 for the expanded indications.
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HOUSTON, Nov. 26, 2018 /PRNewswire/ -- Millar, Inc., medical device manufacturer and OEM solutions partner, is pleased to announce the expansion of the Mikro-Cath Pressure Catheter CE mark to include airway and intra-compartmental pressure measurements, providing European physicians and clinical researchers with access to high-fidelity pressure data that is reliable and unaffected by patient movement or position. The Mikro-Cath had been previously approved for cardiovascular pressure measurements in Europe and received FDA clearance in March 2017 for the expanded indications.
Originally designed as a cardiovascular medical device, it was quickly determined the Mikro-Cath could add value to other clinical applications. The new expansion will allow leading physicians in Europe to seek improvements in respiratory care as well as deliver a continuous monitoring technique for measuring compartment pressure and accurately diagnosing acute compartment syndrome as soon as it's suspected. The Mikro-Cath can also be readily integrated in more critical care programs involving trauma patients undergoing ventilation treatment. The increased level of continuous data accuracy for both respiratory and compartment pressure applications may also support faster decision making with improved data. "This has been a long awaited approval and we look forward to working with physicians that have been eager to utilize the Mikro-Cath for these applications. We anticipate that this will open an opportunity for an improvement in patient care, specifically in the respiratory market," reports Matthew Davis, Director of International Sales and Business Development. Millar also received ISO 13485:2016 certification of its quality management system following completion of an audit by British Standards Institute (BSI), the international governing body for quality medical device manufacturing. This certification demonstrates the company's focus on quality and demonstrates its ability to provide medical devices that consistently meet both customer and applicable regulatory requirements. For nearly 50 years, Millar has manufactured MEMS sensor-enabled catheters that deliver the most reliable measurement of physiologic pressures and have been used to advance medical research and device development in cardiovascular, urodynamic, neurosurgical care and orthopedic applications. About Millar, Inc.
SOURCE Millar, Inc. |
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