PLYMOUTH, Minn., Aug. 22, 2017 /PRNewswire/ -- Preceptis Medical announces the enrollment of the first patient in a prospective, office-based study at Health Partners Clinic (St. Paul, MN) with Principal Investigator Frank Rimell M.D. The study is designed to evaluate the use of Hummingbird TTS (Tympanostomy Tube System) for placing ear tubes in children in the convenience of the physician's clinic, using local anesthetic. The device is currently FDA cleared for use with conscious sedation in hospital or surgery center settings and has successfully treated over 1,000 ears.
The Hummingbird TTS uses a One-Pass™ technology to reduce manipulations to the eardrum, pain, and time during ear tube placement. This enables a conscious sedation alternative to general anesthesia on a patient who is moderately sedated, but awake.
"The company has taken a careful approach to establishing the safety of the Hummingbird in a hospital setting for even the littlest children who require ear tubes," says CEO Steve Anderson. "The next step is to demonstrate the Hummingbird's ability to allow the ENT to safely treat them in-clinic, too." The potential to place ear tubes for more patients in the office, allows more options and more convenience for both parents and physicians to choose the location —hospital, surgery center or office — that best fits the needs of the patient.
Preceptis is also pleased to announce a peer-reviewed publication, Tympanostomy Tube Placement in Children Using a Single-Pass Tool with Moderate Sedation with lead author Shelagh Cofer MD (Mayo Clinic, MN) in the Otolaryngology Head and Neck Journal.1
In their continued effort to advance pediatric tympanostomy technologies for children, Preceptis has provided an educational grant to Vindico Medical to host an independent continuing medical education symposium during the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) on Sept. 11 in Chicago, IL. The panel, consisting of an ENT surgeon, pediatric anesthesiologist and pediatrician, will discuss concerns and the recent FDA Warning surrounding the risk of repeat exposures to general anesthesia in children under 3 and its effect in practice on the surgeons on the front lines. This includes ear tube surgery, one of the most common and most repeated pediatric surgeries using general anesthesia, in the U.S.2-4
Truven Health Analytics, Tympanostomy Outpatient View and Five Year Forecast, 2015
O'Niel, Mallory B., et al. "Tracking tympanostomy tube outcomes in pediatric patients with otitis media using an electronic database." International journal of pediatric otorhinolaryngology 79.8 (2015): 1275-1278.