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https://www.accessdata.fda.gov/cdrh_docs/pdf10/K103595.pdf
Acciarent Tympanostomy Tube and Tympanostomy Tube Delivery System Technological The Tympanostomy Tube Delivery System is a mechanical device that Characteristics: can create a myringotomy and deliver the Acciarent Tympanostomy Tube. The Acciarent Tympanostomy Tube is provided pre-loaded in the subject device.
https://clinicaltrials.gov/ct2/show/NCT02150044
May 29, 2014 · Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion (inVENT2) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
https://clinicaltrials.gov/ct2/show/results/NCT02150044
Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion (inVENT2) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
http://www.io.nihr.ac.uk/wp-content/uploads/migrated/2740.e51265a9.AventaMeddevice.pdf
The TULA system by Acclarent Inc. is another tympanostomy tube delivery system that is currently in development for the placement of tympanostomy tubes in children with otitis media. The system is used to make an incision in the tympanic membrane and insert a pre-
https://patents.google.com/patent/EP2453855B1/en
EP2453855B1 EP10735391.4A EP10735391A EP2453855B1 EP 2453855 B1 EP2453855 B1 EP 2453855B1 EP 10735391 A EP10735391 A EP 10735391A EP 2453855 B1 EP2453855 B1 EP 2453855B1 AuthorityAuthor: Greg Liu, Rohit Girotra, John H. Morriss, Julie D. Vrany, Hung V. Ha, Bryan Knodel, Jeffrey A. Walke...
https://www.jnjmedicaldevices.com/en-US/service-details/what-are-differences-between-acclarent-aera-and-ear-tubes
They also may be called tympanostomy tubes, myringotomy tubes, ventilation tubes, or PE (pressure equalization) tubes. ... The ACCLARENT AERA ® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in …
https://www.bioworld.com/articles/431413-fda-gives-green-light-to-tusker-medicals-ear-tube-delivery-system
The Tubes Under Local Anesthesia (Tula) system is the first delivery system for tympanostomy tubes, commonly known as ear tubes, that can be performed in young children under local anesthesia in a doctor’s office. Tympanostomy tubes are inserted into the eardrum when antibiotics fail to adequately treat ear infections.Author: Meg Bryant
https://www.ncbi.nlm.nih.gov/pubmed/26611339/
Tube placement using the TDS was successful in 96.6% (114/118) of attempted ears. A single TDS was required in 105 ears, while more than 1 device was required in 9 ears. Of the 70 patients enrolled in study, 63 (90.0%) successfully received tubes in all indicated ears during their in-office visit.Author: Jacob W. Zeiders, Charles A. Syms, Mary T. Mitskavich, David M. Yen, Daniel T. Harfe, Ryan D. Shield...
https://www.cadth.ca/tympanostomy-tube-insertion-system-children-otitis-media
Oct 08, 2014 · A surgical procedure consisting of making an incision in the tympanic membrane (myringotomy) and placing a tympanostomy tube in the incision is used to drain fluid from the middle ear and provide ventilation of the middle ear space. 5 Tympanostomy tubes improve hearing and reduce the risk for effusion and recurrent infections in children with otitis media. 5 Tympanostomy tube insertion …
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3068091
Acclarent followed up on this report to gather additional info. The vp of medical affairs contacted the reporting physician. The physician reported inserting the subject device with the acclarent tube delivery system on (b)(6) 2012. The procedure was said to be uneventful, and tube delivery system deployed the tube properly per the physician.
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