Medical device maker and OEM solutions partner Millar has received approval from the Therapeutic Goods Administration (TGA) in Australia for their Mikro-Cath Pressure Catheter.
The Mikro-Cath is a single-use pressure catheter designed for use in diagnostic and research procedures in medicine.
The catheter is recommended for measuring intra-compartmental, airway, and cardiovascular pressures in humans.
According to the firm, it can be utilised as a limited-contact, minimally invasive device for only 24 hours.
The regulatory expansion will provide Australian physicians and clinical researchers access to high-fidelity pressure data that is reliable and unaffected by patient movement or position.
The technology provides ease of calibration to get access to data faster, a clean, accurate signal to eliminate the guesswork during analysis, and real-time data directly from the source.
The company said the device is also suitable for diagnosing chronic exertional compartment syndrome (CECS) where a continuous intramuscular pressure signal during exercise can be helpful.
Millar chief commercial officer Matt Davis said: “This approval has been long-awaited, and we look forward to working with Australian clinicians who are interested in acquiring the most comprehensive and reliable cardiovascular, airway, and compartment pressure data.
“As a nation of sports enthusiasts, we anticipate that this regulatory approval will also open an opportunity for an improvement in patient care within the compartment syndrome monitoring space in Australia.”
The Millar Mikro-Cath is authorised for measuring intra-compartmental pressures, airway pressures, and cardiovascular pressures in the US and Europe in addition to Australia.
For more than 50 years, Millar has produced MEMS sensor-enabled catheters that provide the most accurate assessment of physiologic pressures.
The catheters have been applied to advance medical research and the development of devices for orthopaedic, cardiovascular, respiratory, and neurosurgical applications.
