PLYMOUTH, Minn., July 19, 2016 /PRNewswire/ -- Preceptis Medical announces its U.S. limited market launch of the Hummingbird TTS (Tympanostomy Tube System) that uses conscious (moderate) sedation for children's ear tube placement. The company looks forward to offering parents and pediatricians an alternative to general anesthesia for their children's ear tube procedures -- the most common pediatric surgery in the U.S.
Older patients typically have ear tubes inserted in the ENT physician's office. Young children and infants are not yet able to sit still or tolerate the procedure, requiring that it be done in an operating room under general anesthesia. The Hummingbird™ TTS minimizes the time and discomfort to little ears by inserting the tubes with its One-Pass™ technology. This allows physicians the option to use conscious sedation to keep the child comfortable and awake during the short procedure, which is performed in a safe, hospital setting.
With heightened concern around the risk of general anesthesia for children from the FDA and other medical societies, the Hummingbird TTS option allows ear tubes to join the growing trend of performing minor pediatric surgeries using conscious sedation.1, 2 Pediatric Critical Care physician Gwen Fischer M.D. feels, "pediatricians in general will be in favor of proven technologies that offer alternatives to general anesthesia for children." As the Founder and Director of the Pediatric Device Innovation Consortium (pdicmn.org) at the University of Minnesota, Dr. Fischer is integral in their mission to support the development of new pediatric technology.
"We are excited to bring this important option to this high volume pediatric surgical procedure," says Steve Anderson, CEO of Preceptis. Fairview Health Services and Children's Hospital of Minnesota/St. Paul are the first to offer the procedure to the public in the Twin Cities area. Former clinical study sites included Fairview Health Services at Maple Grove and the University of Minnesota Masonic Children's Hospital, Children's Hospitals and Clinics of Minnesota/St. Paul and the Mayo Clinic.
Gina Bassetto, who chose the Hummingbird TTS procedure for her child states, "Parents need to know that this option is out there. When I make medical decisions for my family I want to take the path that is the least risk to my child." Gina is a mom and speech pathologist who lives in Houston Texas with her family.
1. Summary Minutes of the Anesthetic and Life Support Drugs Advisory Committee Meeting of the FDA, 2007, 2011, 10903 New Hampshire Avenue, Silver Spring, MD 20993
2. Rappaport, et al. Anesthetic Neurotoxicity – Clinical Implications of Animal Models, NEJM, MED 372:9, 26 Feb15
SOURCE Preceptis Medical, Inc.