Tusker Medical develops the Tula System, which is an in-office ear tube delivery system to treat recurrent or persistent ear infections. The pediatric ear tubes won FDA breakthrough device designation in November last year.
“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,” president of sports medicine and ENT at Smith & Nephew Brad Cannon said in a news release.
The iontophoresis system features a small electrical current that delivers a local anesthetic into the eardrum before tube insertion. The electrical current can accelerate tissue uptake of the ionic drug. Tusker Medical’s Tula System is designated for use in adults and children as young as six months old.
“I am immensely proud of the pediatric-focused technology that we have developed, and to receive PMA approval along with breakthrough device designation from the FDA. Smith & Nephew is well-placed to accelerate and broaden the launch of Tula and we look forward to working together to improve the quality of life of the millions of children who suffer from ear infections every year.”