Smith+Nephew Launches Tula Ear Tube Placement System

Smith+Nephew announced market introduction and first commercial procedure of its Tula System—an in-office solution for placement of tympanostomy tubes (commonly known as ear tubes).
 
The Tula System gives ENT surgeons an option to place ear tubes in an awake child during an office visit without the need for general anesthesia. The physician numbs the eardrum using a novel, child-friendly anesthesia while the patient may sit up, play, and remain with their parent. A specialized tube delivery system allows the physician to place an ear tube in less than half a second, minimizing the amount of time the child needs to remain still. Most children return to normal activities immediately following the Tula procedure.^1,2
 
The first procedure utilizing the Tula System since receiving FDA approval was successfully performed yesterday by Dr. Ritvik Mehta, M.D., Otolaryngologist of California Head and Neck Specialists and investigator in the Tula Pivotal Clinical Study. “This personally hits home as my daughter had ear tube placement performed in the operating room,” explained Dr. Mehta. “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.”
 
Acute otitis media (commonly referred to as an ear infection) is one of the most prevalent childhood ailments in the United States, with an estimated annual cost of $2.8 billion.³ Every year in the United States alone, approximately 700,000 tympanostomy tube procedures are performed on children to address symptoms related to recurring ear infections and fluid in the middle ear.⁴
 
“I really like the Tula System because it gives parents the option of getting their child’s ear tubes placed without a general anesthetic,” said Dr. Lawrence Lustig, Department Chair of Otolaryngology-Head & Neck Surgery Columbia University School of Medicine and New York Presbyterian Hospital and Principal Investigator of the Tula Pivotal Clinical Study. “From a parent’s perspective, this is an enormous advantage—less time off work, and performed in an office setting. This technology represents a broader movement in our field towards patient-centered therapies.”
 
“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,” said Brad Cannon, President, ENT and Sports Medicine for Smith+Nephew. “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.”
 
The Tula System is now available in select markets in the United States and will be available nationwide by the beginning of 2021.
 
References
¹ Procedure typically lasts about 35 minutes. Tula Pivotal Study.  Data on file
² Lustig LR, Ingram A, Vidrine M, et. al. In‐Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery. Laryngoscope 130; S1-S9, 2020.
³ Ahmed S, Shapiro NL, Bhattacharyya N. Incremental Health Care Utilization and Costs for Acute Otitis Media in Children. Laryngoscope 124(1); 301-305, 2014.
⁴ Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data from Hospitals and Ambulatory Surgery Centers: United States, 2010. National health statistics reports 102; 2-14, 2017.