TULA System for Awake Ear Tube Placement FDA Approved

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Ear infections are notoriously common in children, but the usual treatment is relatively straightforward. An incision is made in the ear drum (myringotomy) and tympanostomy tubes are placed to drain out the liquid that has built-up within. However, because children are involved, pain is a major limitation and it is very difficult to get the kids to stay still long enough to achieve success. Therefore, general anesthesia is typically a required part of the process, which comes with the potential for side effects, high treatment costs, and an impression that the procedure is a full scale surgery.

Now, a company called Tusker Medical, based in Silicon Valley, has won FDA approval for its Tula System to deliver local anesthesia directly toward the ear drum and place an ear tube without any pain.

Indicated for patients six months of age and older, the Tula Iontophoresis System delivers an ionized anesthetic agent, called TYMBION, and which is a combination of lidocaine and epinephrine, into the ear. The electrically charged medicine is forced to move toward the ear thanks to an electric current generated within an ear plug specifically fitted to the patient. The plugs make sure the numbing solution stays within the ear and doesn’t drip out. It takes about ten minutes to deliver the local anesthetic, during which time the child is free to do whatever he/she wants.

Once anesthetized, the Tula Tube Delivery System is utilized to create a hole in the eardrum and position the ear tube.

“Ear tubes are our recognized standard for addressing recurrent ear infections or hearing loss associated with persistent fluid in the middle ear, but conventionally children must be treated in an operating room under general anesthesia,” said Erik Waldman, Chief of Pediatric Otolaryngology at Yale New Haven Children’s Hospital in New Haven, CT, in a Tusker Medical press release. “We’re excited to be able to offer a truly patient-centered option that gives patients and parents an alternative to general anesthesia, addresses common causes of stress from surgery, and allows most patients to immediately return to normal activity.”

“The recently completed pivotal study of 269 in-office patients represents the capstone of an extensive development program over several generations of systems that included 16 clinical trials and over 1,000 subjects studied,” said Amir Abolfathi, President and CEO of Tusker Medical, in the same press release. “We appreciate the close partnership of the otolaryngologist physician community and specialty leadership. And we appreciate FDA’s vision in conferring Breakthrough Device status for the Tula System.”

Link: Tusker Medical technology page…

Via: FDA and Tusker Medical





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