Smith & Nephew has acquired Tusker Medical, a company that has developed Tula, a system to treat recurrent or persistent ear infections. The London-based company kept the financial details of the deal mum.
The acquisition comes hot on the heels of CA-based Tusker Medical obtaining a PMA from FDA for Tula. MD+DI included the Tula system in a list of Devices Recently Approved by FDA.
The system enables placement of ear tubes in the physician’s office without general anesthesia for patients six months and older. Using Tula, a physician numbs the eardrum using, child-friendly anesthesia while the patient may sit up, play, and watch videos. A specialized tube delivery system allows the physician to place an ear tube precisely in less than half a second using an automated device.
Tula uses a small electrical current to deliver the Tymbion to the eardrum before tube insertion. The fitted earplugs keep the local anesthetic solution in the ear canal. Once the eardrum is adequately numb, the physician removes the earplugs and uses the Tula Tube Delivery System to create a small hole in the eardrum and insert the ear tube.
The effectiveness of the Tula System for the delivery of ear tubes was assessed in a clinical study of 222 pediatric patients, ages 6 months to 12 years. Physicians were successful in placing ear tubes using the Tula System in 86% (103 of 120) of children ages 6 months to 4 years and in 89% (91 of 102) of children ages 5 to 12 years.
In the same study, pain and distress related to the procedure were evaluated. A video-based pain scoring method was used for younger children, ages 6 months to 4 years. Older children, ages 5 to 12 years, self-reported pain scores. For all patients, pain and distress were rated using a 0 to10 scale, where 10 represents severe pain or distress, and 0 represents no pain or distress. Children ages 6 months to 4 years had an average observed score of 4 for the ear tube insertion phase of the procedure, which decreased to 1.3 at the end of the procedure. Children ages 5 to 12 years with successful ear tube insertion reported an average score of 3.3 for the tube insertion phase of the procedure, which decreased to 1.7 at the end of the procedure.
London-based S&N said Tusker is highly complementary to its existing ENT business, with the same customer and patient populations. S&N added the COBLATION technology is widely-used in tonsillectomy and soft tissue management and is used by both general and pediatric ENT surgeons.
In a release, Brad Cannon, President of Sports Medicine & ENT at S&N, said, “the Tula System is a truly innovative option for physicians treating incredibly common ear conditions. It is a game-changer when treating children, removing the risk and stress of general anesthesia for patients and caregivers. Tula is a highly complementary addition to our ENT portfolio, and we are excited to significantly improve the treatment options for surgeons and patients with the launch of this technology.”