Nobles Medical Gains FDA Approval to Restart NobleStitch Clinical Trial

Nobles Medical Technology 2, a provider of cardiovascular closure solutions, announced it received FDA approval to resume its NobleStitch EL clinical trial for patent foramen ovale (PFO) closure. The minimally invasive device uses a suture-only method to close the small opening between the heart’s upper chambers, offering a potential alternative to metal implants. The company paused enrollment earlier this year following requests for additional safety and performance data, which it says have now been addressed.

A Pre-Market Approval will be submitted upon completion of the study, with patient enrollments set to continue in the last quarter of 2025. The device utilizes a proprietary percutaneous suturing technique to close defects without requiring a permanent implant.

Posted by MedCloudInsider Editors on 10/07/2025