Planned Testing

Benchtop Tests

Sound Test

This test measures the ability of the valve to dampen sound, preventing the patient from hearing their own voice or the movement of air. A speaker plays a series of preset tones through a chamber. Microphones record the sound volume on either end of the valve, allowing for the volume drop across the valve to be measured.

Acceptance Criteria

Each device will pass if it is able to absorb ≥ 13.1 dB for all tested sound levels.

Pressure Test

This test is intended to measure the ability of the valve to dissipate pressure before reaching a level that would cause discomfort for the patient. A linear servo pushes a plunger through a sealed chamber while a pressure transducer records the pressure. The valve prototype is mounted to the end of the pressure chamber. Valves that fail to open will result in large pressure buildups.

Acceptance Criteria

An observed maximum pressure gradient < 500 Pa for 30 repetitions on one device shall be considered a success.

Timeline Post Benchtop Testing

Preclinical Study with Pigs

Twenty miniature pigs, which have a ET structure and size similar to adult humans, will have their ET dilated with balloon dilation catheters to mimic pET and then have the pET device implanted into their ET. The animal skull will be imaged with CT to view device placement and function and the animals will be sacrificed in two cohorts at weeks 24 and 48 after placement to visualize tissue response to device placement. Necessary changes to the device will be made throughout the preclinical study to ready the device for human clinical studies.

Clinical Trial

A 50 patient, single-blinded, prospective, multicenter, randomized controlled trial will be completed similar to previous studies in the ET. Patients must fit traditional criteria for moderate to severe pET. Participants meeting enrollment criteria will be randomized 1:1 to either pET valve placement or gel foam shim placement. No sham control group to test the placebo effect is needed because the patients are blinded from the treatment type. Post surgical follow-up will be completed at 1, 3, 6 and 12 months. The primary efficacy endpoint will be evaluated as the lack of symptoms at each follow up. The primary safety endpoint will be the rate of complications, defined as the percent of serious adverse events related to the device or procedure.

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