Millar, Inc., a medical device manufacturer and OEM solutions partner, is pleased to announce that they have 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 intended to be used for medical research and diagnostic purposes. The catheter is indicated to measure cardiovascular, intra-compartmental, and airway pressures in the human body. The catheter is used as a minimally invasive device under short-term limited body contact (<24 hours).
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This 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 Mikro-Cath’s 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 to assess hemodynamics and airway flow.
As a gold standard method for measuring pressure, the Millar Mikro-Cath™ is also highly suitable for diagnosing chronic exertional compartment syndrome (CECS) where a continuous intramuscular pressure signal during exercise can be a helpful diagnostic utility in patients with symptoms consistent with CECS. Patients with CECS experience pain during exercise that subsides with rest. CECS is commonly found among Australian athletes such as long-distance runners, football players, and basketball players. According to Global Market Insights Inc., the compartment syndrome monitoring devices market value surpassed USD 41 million in 2021 and is expected to expand at a CAGR of 4.6% over the forecast period (2021-2031).
“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.” shares Matt Davis, Chief Commercial Officer. “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.”