Insightra cleared to sell inguinal hernia system in U.S.

IRVINE, CA – Insightra Medical, Inc. has received clearance from the US Food and Drug Administration for its Freedom Inguinal Hernia System, which was developed to help address some causes of post-operative pain.

Majority of surgical procedures to treat inguinal hernias involve some form of prosthesis such as surgical meshes or plugs, held in place using sutures, tacks or other fixation methods. This fixation is thought to be one of the reasons for post-operative chronic hernia pain.

The system contains ProFlor, the flower-shaped implant made of polypropylene that recoils when compressed. A special delivery device is used to load the implant under compression. It is then released into the inguinal hernia defect where it stabilizes in the tissues without the need for fixation.  The relatively simple implantation technique that can be performed through a small incision under local anesthesia. The delivery device helps to deliver a small pre-peritoneal disk attached to the implant core, which helps to cover the defect from behind.

Insightra Medical’s system has been available outside of the USA in a limited clinical launch for over three years.

Initial clinical results from two studies in Italy have shown that the implant stays in place and the implant has shown excellent post-operative pain scores. The product has been available outside of the USA in a limited clinical launch for over 3 years and has been implanted in over 200 patients, some of the patients with a follow up beyond 36 months. Results in terms of complications, pain, discomfort and recurrence remain very encouraging.

More than 800,000 inguinal hernias are performed each year in the United States, with a majority of surgical procedures involving some form of prosthesis such as surgical meshes or plugs. These systems are often fixed in place using sutures, tacks or other methods that hold the devices firmly in place. This “fixation” is thought to be one of the reasons for the syndrome of postoperative chronic hernia pain. Flat meshes have been shown to shrink up to 30%, while plugs are as high as 70%. In both cases the implant can pull on the fixation, become rigid or feel like a hard, fibrotic foreign body.

Insightra plans to conduct ongoing studies and begin a U.S. training program for physicians.