FDA grants IDE approval for study of vasectomy device
The study is set to begin in January 2024.
The FDA has granted an Investigational Device Exemption (IDE) approval to begin a study of a minimally invasive surgical device to perform a sealed vasectomy procedure (SVP), announced Signati Medical, the developer of the tool, in a news release.1
The IDE study will be conducted at Louisiana State University Medical Center.
“Our investments in research and development along with technological advancements have enabled Signati to develop the first minimally invasive vasectomy product in a market that is on tract to achieve remarkable growth,” said William Prentice, CEO of Signati Medical, in the news release.1
The IDE study will be conducted at Louisiana State University Medical Center in New Orleans and is intended to begin in January 2024. The trial will assess the safety and efficacy of the device in patients undergoing an SVP.
According to the news release, the investigational SVP device is the first innovation in the realm of vasectomy in over 20 years. The office-based procedure is designed to take only minutes to perform and would provide an easier recovery for patients, Signati says.
Gerard Henry, MD, the Chief Medical Officer at Signati Medical, commented in the news release, "The SVP should make vasectomies faster, easier, and safer for men seeking sterilization with much quicker return to full activity."1
In collecting Good Laboratory Practice (GLP) data, the device met safety end points of sealing, no thermal spread, and clinically documented wound healing, according to Signati.2
The company also noted that the IDE study would be the final step in receiving FDA approval to market their SVP in a commercial setting.
References
1. Signati Medical, Inc. received FDA approval for IDE study. News release. Signati Medical. December 20, 2023. Accessed December 22, 2023. https://signatimed.com/signati-medical-inc-receives-fda-approval-for-ide-study/
2. Signati Medical files IDE study with FDA. News release. Signati Medical September 26, 2023. Accessed December 22, 2023. https://signatimed.com/signati-medical-files-ide-study-with-fda/
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