New Grommet Device Streamlines Pediatric Ear Surgery

A novel tympanostomy tube device (TTD) allows surgery to be performed on children while they are awake.

The AventaMed (Cork, Ireland) Solo + TTD is an all-in-one integrated device for the insertion of ear tubes that combines a disposable myringotomy knife, a preloaded TTD, and a control button. Once deployed, a myringotomy is performed; the activation of the control button simultaneously retracts the knife and deploys the preloaded TTD, which is collapsed at the tip of the device, into an open position. A stopper proximal to the tip acts as a safety feature to minimize the risk of inadvertent over-insertion into the middle ear space.

“The insertion of ear tubes is the most frequently performed surgical procedure on children. The Solo+ enables doctors to offer patients' families a significant alternative to what has been performed until now,” said Keith Jansen, President and CEO of AventaMed. “More and more different types of procedures are being done in an ambulatory setting; Solo+ enables ear tube placements to be done there as well. This should also mean that significant cost savings can be realized for the payers of these procedures.”

“The Solo+ performed very well and enabled me to implant a tympanostomy tube in each ear in just a few seconds while the patient was awake. Ear tubes are usually inserted while a child is asleep using general anesthesia,” said otorhinolaryngologist João Pimentel, MD, of Hospital da Luz Oeiras (Lisbon, Portugal). “Patients, and their families, no longer must wait in a hospital for a prolonged period of time while the patient is prepared for surgery and then recovers. As a result, parents can also return to their normal activities immediately.

Otitis media is a middle ear inflammation that occurs in the area between the tympanic membrane and the inner ear, including the eustachian tube. Though painful, otitis media is not threatening and usually heals on its own. In chronic cases with effusion, a TTD placed into the eardrum reduces recurrence rates in the six months after placement, but has little effect on long term hearing. TTD’s are recommended in those who have more than three episodes of acute otitis media with effusion within a six month period, or four in one year.

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