The device features high-flow oxygen therapy and can be used for both invasive and non-invasive ventilation under Emergency Use Authorization from the FDA due to shortages from the COVID-19 pandemic.
Movair said it is filing for permanent 510(k) FDA clearance for the Luisa by the end of 2021.
The device weighs 8 lb and can run for up to 18 hours on battery power, Movair said yesterday in a news release.
“Increased respiratory patient illness, COVID-19 and product recalls have created a critical need for ventilators in the United States,” Movair CEO David Shockley said in the news release. “We’re addressing this demand with the launch of Luisa, a portable and compact home ventilator, designed and made in Germany, that also provides patients with high-flow oxygen therapy. At Movair, we’re committed to advancing life-empowering respiratory therapies that help patients breathe better and live better. The launch of Luisa underscores this commitment.”
Movair is the exclusive U.S. dealer for Lowenstein Medical., which developed the third-generation Luisa ventilator and manufactures it in Germany. The device has been marketed in Europe since 2020.
Luisa can be prescribed to certain patients diagnosed with chronic respiratory failure due to chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). Luisa can also provide high-flow therapy to patients that need at-home ventilation and also offers FIO₂ and SPO₂ monitoring and ventilation from 100 ml VT, Movair said.
Austin, Texas-based Movair also announced its new name “to coincide with the company’s renewed focus on strengthening and streamlining its position as an industry-leading provider of innovative respiratory therapy technologies.”
The company sold its AffloVest respiratory therapy business to Minneapolis-based Tactile Medical last month.