Insightra Medical has announced it has received FDA clearance for its new inguinal hernia system, according to a news release.
The Freedom inguinal hernia system includes the ProFlor, a flower-shaped, open structure implant made of polypropylene that recoils when compressed, according to the company. Using a delivery device, the implant is loaded under compression and then released into the inguinal hernia defect where it is designed to stabilize in the tissues without the need for fixation.
Implantation of the system can be performed through a small incision under local anesthesia.
Insightra said it intends to conduct ongoing studies and begin a U.S. training program for physicians.
Insightra Medical is headquartered in Irvine, Calif.
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