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The design goal is to overcome the gaps in pET treatment by providing a minimally invasive device that relieves pET symptoms over the long term via securement for 10 years. To relieve autophony and increase patients' quality of life, the device absorbs sound and equalizes pressure between the middle ear and the nasal cavity.
The design goal is to overcome the gaps in pET treatment by providing a minimally invasive device that relieves pET symptoms over the long term via securement for 10 years. To relieve autophony and increase patients' quality of life, the device absorbs sound and equalizes pressure between the middle ear and the nasal cavity.
Valve-in-Stent Device
Valve-in-Stent Device
Altered ACCLARENT AERA® Delivery System
Rigid Body & Valve
Design: The Valve-in-Stent device is composed of an outsourced stent and the rigid body containing a valve, which is designed in-house. The device is delivered through the nasal cavity and furthermore to the isthmus of the eustachian tube (ET). The stent is secured in the ET due to the hourglass shape and the ET anatomy. The valve absorbs sound, and the valve will allow for pressure equalization in either direction.
Design Benefits:
Stent utilizes anatomical structure of ET for securement.
Stent and rigid body keep the ET open throughout device life-cycle even with anatomical ET changes.
Indications for Use: Patient diagnosed with pET after experiencing autophony.
User during Delivery: ENT physician surgically implants device in OR on outpatient basis. Patient receives general anesthesia and is recommended to take OTC pain medications during recovery.
Use Cases:
High pressure events (e.g. sneezing) that place a much larger than normal load on the valve.
Cycle 48 times per day. One cycle includes the valve opening and closing.
Maintain structure and function for 10 years.
Compatible with altered ACCLARENT AERA® delivery system.
Device Requirements
Device Requirements
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