Vapotherm Gets ‘Breakthrough’ Status for Oxygen Assist

FDA has granted Vapotherm a breakthrough device designation for its Oxygen Assist Module for use in the company’s Precision Flow system, a mask-free alternative to nasal continuous positive airway pressure as well as noninvasive positive pressure ventilation. The module assists staff in maintaining a targeted SpO (amount of oxygen in the blood) range, the company says.

The effectiveness of the Vapotherm OAM algorithm was evaluated in a 2018 study published in the Archives of Disease in Childhood. “The data show that trained staff using manual controls alone were able to maintain premature infants’ oxygen saturation in the physician-prescribed target range 49% of the time,” the company says. “When using the OAM device, the staff were able to maintain the target oxygen saturation range 80% of the time, while at the same time requiring significantly fewer manual adjustments to the oxygen delivered by the equipment.”