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.

Learn more...

INGEVITY+ Post Approval Study

General
Study Status	Completed
Application Number / Requirement Number	P150012 S083/ PAS001
Date Original Protocol Accepted	12/16/2019
Date Current Protocol Accepted	06/19/2020
Study Name	INGEVITY+ Post Approval Study
Device Name	Ingevity + Lead - Active Fixation
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	Objective Performance Criterion
Analysis Type	Analytical
Study Population	Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead. The INGEVITY+ Clinical Study is a prospective, non-randomized, multi-center, post-market study.
Study Population	This is a one-armed study where every subject is assigned to treatment, where treatment means implanted, or attempted implant of INGEVITY+ leads in the right atrium and ventricle.
Sample Size	At least 105 subjects will be enrolled in the study to achieve 200 implanted or attempted leads. The study will include approximately 20 sites in North America.
Key Study Endpoints	Primary Safety Endpoint: Lead-related complication-free rate from implant through 3-months post-implant Primary Effectiveness Endpoint: Pacing capture threshold at 3-months post-implant Secondary Effectiveness Endpoint: Sensed amplitude and pacing impedance at 3-months post-implant
Follow-up Visits and Length of Follow-up	The study duration for each subject is expected to be approximately 3 months. Subjects will be exited from the study after their 3 month visit.
Interim or Final Data Summary
Actual Number of Patients Enrolled	109
Actual Number of Sites Enrolled	13
Patient Follow-up Rate	One hundred and ninety-eight (198) leads among one hundred (100) subjects have completed either the 3-month visit or 91 days of follow-up. One hundred and one (101) subjects have completed the 3-month follow-up visit.
Final Safety Findings	The lead-related complication-free rate from lead implant to 3 months for all leads was 98.5%, with a lower confidence limit of 95.4%.
Final Effect Findings	As of the date of the report snapshot, 98.9% of leads (184 of 186) have reported a pacing capture threshold less than or equal to 2V with a 0.4ms pulse width.
Study Strengths & Weaknesses	The safety endpoint through 3 months of follow-up was met. All effectiveness endpoints at 3 months of follow-up were met. The data confirms the safety and effectiveness of the INGEVITY+ lead.
Recommendations for Labeling Changes	no

INGEVITY+ Post Approval Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
six month report	06/15/2020	05/22/2020	On Time
one year report	12/15/2020	12/15/2020	On Time
final report	06/15/2021	05/26/2021	On Time

Contact Us

---

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

Additional Resources

---

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