medical device guru

FDA Fast Tracks Aerosurf RDS in Premature Infants

Biologics, Wound Care, Infection Prevention September 22, 2016

The Food and Drug Administration (FDA) has granted Fast Track designation to Aerosurf (lucinactant for inhalation; Windtree Therapeutics) for the treatment of respiratory distress syndrome (RDS) in premature infants.

Aerosurf

Aerosurf is an investigational drug/device product that combines Windtree’s proprietary aerosolized KL4 surfactant with its novel aerosol delivery system (ADS) based primarily on its capillary aerosol generator technology. Aerosurf is under development for the noninvasive administration of surfactant therapy to premature infants with RDS with the potential to reduce the need for invasive endotracheal intubation and mechanical ventilation.

Windtree Therapeutics is currently evaluating Aerosurf in a multinational, Phase 2b clinical trial in premature infants 26 to 32-week gestational age receiving nasal continuous positive airway pressure (nCPAP) for RDS.
For more information visit Windtreetx.com.

Read More – Source: Aerosurf Fast Tracked for RDS in Premature Infants – MPR

AUTHOR - Authorship Credit Noted Above
SHARE
YOUR FIRST STEP TO SUCCESS
IS JUST A CLICK AWAY
Search our current open opportunities to take your first step to success in Medical Device and Healthcare IT today. Focusing on you and your career is our Job, now it’s time for you to find yours. Let’s get started.
VIEW JOBS