London-based Smith & Nephew’s Tula system is an in-office option that allows surgeons to place ear tubes in an awake child without the need for general anesthesia.
Physicians using the Tula system numb the eardrum with a novel, child-friendly anesthesia before a specialized tube delivery system allows the physician to place an ear tube in less than half a second. Most children return to normal activities immediately after the Tula procedure, according to a news release.
Dr. Ritvik Mehta, an otolaryngologist with California Head & Neck Specialists and investigator in the Tula pivotal study yesterday performed the first Tula procedure since the system received FDA approval.
“This personally hits home as my daughter had ear tube placement performed in the operating room,” Mehta said in the release. “Even though I’m in a position to know exactly what to expect, it was a stressful event. I’m genuinely excited to be able to perform the same ear tube procedure, but in an office setting where children and families may avoid exposure to the risks and stresses of general anesthesia – fasting, separation and after-effects.
“This is a significant improvement to what we as ENTs can offer our patients.”
Smith & Nephew picked up the Tula system after its January acquisition of Tusker Medical. The pediatric ear tubes designed for treating recurrent or persistent ear infections won FDA breakthrough device designation in November of last year.
The company said in the release that the Tula system is now available in select markets in the U.S., with nationwide availability planned for the beginning of 2021.
“We are very excited to deliver a truly disruptive technology that elevates the standard of care by providing an alternative to general anaesthesia-based tympanostomy,” Smith & Nephew president of ENT & sports medicine Brad Cannon said. “And, by better utilizing limited healthcare resources and freeing up precious OR space, it may potentially save the overall healthcare system hundreds of millions of dollars.”