Tusker® Medical today announced United States Food and Drug Administration (FDA) approval of the Tula® System, which enables myringotomy and placement of tympanostomy tubes (commonly known as ear tubes) in the physician’s office without general anesthesia for patients 6 months and older.
Menlo Park, CA, Dec. 04, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Tusker® Medical today announced United States Food and Drug Administration (FDA) approval of the Tula® System, which enables myringotomy and placement of tympanostomy tubes (commonly known as ear tubes) in the physician’s office without general anesthesia for patients 6 months and older. Ear tube procedures are the most common outpatient surgery for children in the United States, performed approximately 700,000 times annually, with the vast majority in an operating room.
“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. “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.”
Dr. Charles Syms of Ear Medical Group in San Antonio, TX stated, “The Tula System was developed in close collaboration with physicians over many years, with a shared objective of providing patients and their families with an in-office treatment option for ear tubes. This option not only addresses the risks and anxiety associated with the operating room and general anesthesia, but has the potential to deliver significant savings for our healthcare system as well.”
Using the Tula System, an ENT physician numbs the eardrum in about 10 minutes using novel, child-friendly anesthesia, during which the patient may sit up, play, and watch videos. A specialized Tube Delivery System allows the physician to create a myringotomy and insert a grommet-style tube precisely and in less than half a second using an automated device. The rapid delivery avoids prolonged sharps exposure—an important safety feature to protect an awake child. Parents can stay with their child throughout the procedure, which typically takes about 40 minutes. In the Tula pivotal study, children required no sedatives, anxiolytics, or papoose restraints, and 95% of parents reported being very satisfied with Tula.
Amir Abolfathi, President and CEO of Tusker Medical, noted, “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. 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.”
About ear tubes and Tusker Medical: Every year in the United States, one million tympanostomy tube procedures are performed to address recurrent ear infections or persistent fluid in the middle ear, of which approximately 700,000 are performed in children. The vast majority of the pediatric procedures are conducted in an operating-room environment, costing thousands of dollars per procedure and exposing children and families to the risks and stresses of general anesthesia. Tusker Medical has developed a suite of pediatric-focused technologies designed to enable placement of tubes in the comfort of an office environment, and intends to commence a focused commercial effort in targeted US markets in 2020.
About Tula: The Tula System is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION™, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist. Tula may not be appropriate for all children, and potential candidates should discuss options with a physician.
References: https://www.enthealth.org/be_ent_smart/ear-tubes/; OTTER pivotal study data on file, Tusker Medical; Hall et al. Ambulatory Surgery Data From Hospitals and Ambulatory Surgery Centers: United States, 2010; National Health Statistics Reports, 102, Feb 28 2017; Truven Health Analytics/IBM Watson.
Media Contact: Erich Sandoval; (917) 497-2867; esandoval@lazarpartners.com
