Post-Approval Studies (PAS) Database

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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New Enrollment Study (BREATHE Study)

General
Study Status	Ongoing
Application Number / Requirement Number	P240024 / PAS002
Date Original Protocol Accepted	10/03/2025
Date Current Protocol Accepted	10/03/2025
Study Name	New Enrollment Study (BREATHE Study)
Device Name	Genio® System 2.1
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	Device Subjects Serve as Own Control
Analysis Type	Analytical
Study Population	Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	Prospective, Single arm, post approval study to demonstrate the long term safety and effectiveness of the device in treating OSA
Study Population	Adult patients 22 years of age and older who have been confirmed to fail, cannot tolerate or are ineligible to be treated with current standard of care treatments including lifestyle modifications, positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BiPAP] machines), oral appliances (such as mandibular advancement devices), and pharmacotherapy (such as tirzepatide).
Sample Size	229 patients: 25 Investigational sites: US
Key Study Endpoints	* First co-primary endpoint: percentage of responders at 12 months based on AH14, a responder being defined as a subject who satisfies the following criteria: at least a 50% reduction from the average AH14 of screening to 12 months post-surgery and a remaining AH14 less than 20 at the 12-month visit (aka "Sher Criteria"). * Second co-primary endpoint: percentage of responders at 12 months based on OD14, a responder being defined as a subject who satisfies the following criterion; at least a 25% reduction from the average OD14 of screening to 12 months post-surgery. * Incidence of device-related Serious Adverse Events, as reported by investigator and adjudicated by the CEC, at 12 months post-surgery. * Incidence of device-related (including the incidence rate of migration explants and revisions) and procedure-related Serious Adverse Events at 12 months post-surgery.
Follow-up Visits and Length of Follow-up	Follow up at 12,24,36,48 and 60 months
Interim or Final Data Summary
Actual Number of Patients Enrolled	Zero
Actual Number of Sites Enrolled	Zero
Patient Follow-up Rate	N/A
Final Safety Findings	N/A
Final Effect Findings	N/A

New Enrollment Study (BREATHE Study) Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	02/06/2026	02/06/2026	On Time
1 year report	08/08/2026
2 year report	08/08/2027
3 year report	08/07/2028
4 year report	08/07/2029

Contact Us

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Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background