August 18, 2022
Millar, a medical device manufacturer and OEM solutions partner, said it has received approval from the Therapeutic Goods Administration in Australia for its Mikro-Cath Pressure Catheter. The single-use pressure catheter is intended to be used for medical research and diagnostic purposes, the Houston, TX-based company noted.
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.
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, Millar said. The Mikro-Cath's technology is designed to provide 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.
According to the company, 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, Millar 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," said Matt Davis, chief commercial officer at Millar. "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."
In addition to Australia, the Millar Mikro-Cath is also approved for cardiovascular pressure measurements, airway pressure measurements, and intra-compartmental pressures in the United States and Europe.
About the Author(s)
You May Also Like