Tusker Medical’s TULA Pediatric Ear Tubes Awarded Breakthrough Device Designation
Posted on November 26, 2019 by Medtech[y] Staff
After a successful study which evaluated the in-office placement of tympanostomy tubes in approximately 300 children ages 6 months through 12 years old, the FDA has awarded Tusker Medical breakthrough device approval for their Tula (Tubes Under Local Anesthesia) system, which delivers tympanostomy tubes (ear tubes) to young children with recurrent ear infections, in a physician’s office and under local anesthesia.
The Tula System is the first ear tube delivery system that can be performed in young children using local anesthesia in a physician’s office setting. The Tula System consists of the anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of the ear tubes and the anesthetic into the ear drum.
“Today’s approval offers patients an option for the treatment of recurrent ear infections that does not require general anesthesia. As millions of children suffer from ear infections every year, it is important to have safe and effective treatments available to this susceptible patient population,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “This approval has the potential to expand patient access to a treatment that can be administered in a physician’s office with local anesthesia and minimal discomfort.”
The Tula System enables the delivery of an ear tube to patients under local anesthesia in a physician’s office setting, therefore avoiding the administration of general anesthesia. The Tula System uses a small electrical current to deliver a local anesthetic into the ear drum prior to tube insertion. It is approved for use in both adults and children as young as six months of age.
Ear infections are common in children, with the National Institute of Deafness and other Communication Disorders (NIDCD) estimating that 5 of 6 children will have at least one ear infection before their third birthday. While health care professionals frequently prescribe antibiotics as a treatment, if antibiotics fail to treat an ear infection, or if infections continue to occur, a doctor may recommend a surgical procedure to place a small tube in the eardrum. In young children, the delivery of an ear tube has traditionally been performed in a hospital setting or surgery center and required the patient to receive general anesthesia.
The FDA evaluated data provided by the sponsor from 222 pediatric patients to assess the effectiveness of the Tula System for the delivery of ear tubes. The procedural success rate was 86% and 89% in children younger than age 5 and between ages 5-12 years old, respectively. The most common adverse event observed was inadequate anesthesia during the procedure. The Tula System should not be used in patients younger than six months of age or patients who have allergies to some local anesthetics. This product is not intended for patients who may have pre-existing issues with their eardrum, such as a perforated eardrum.
The Tula System was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development to expedite evidence generation and the agency’s review of the product. To qualify for such designation, a device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.