Regulatory Strategy

Prior to clinical studies, animal studies will be completed in miniature pigs over one year. Patulous eustachian tubes will be induced in miniature pigs using ET balloon dilation therapy. The valve-in-stent device will be implanted and imaged with CT over a period of 48 weeks.

Following preclinical studies and an IDE, 50 patients with moderate to severe pET will be enrolled in a single-blinded, multicenter, randomized controlled trial. Participants will be randomized 1:1 to either pET valve placement or gel foam shim placement. 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.

The valve-in-stent device is considered a Class III device and does not related to any predicate devices. Therefore, a Premarket Approval (PMA) application will be submitted to achieve market approval in the United States.