Insightra Medical (Irvine, CA) received FDA clearance for its Freedom Inguinal Hernia System that was developed to help address some of the causes of post-operative pain.
The system consists of the ProFlor implant and a delivery device that sort of works like a syringe. The flower-like implant is compressed into the delivery device, which is in turn inserted into the inguinal hernia defect and deployed. The implant immediately uncoils (blooms?), providing stability but without the use of tacks or sutures that are often associated with post-operative chronic hernia pain.
From the announcement:
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.
A key to the Freedom Inguinal Hernia System is 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 plans to conduct ongoing studies and begin a U.S. training program for physicians.
Here’s a short video demonstrating the loading and delivery procedure for the Freedom system:
Product page: Freedom Inguinal Hernia Repair System
Press release: Insightra Medical, Inc. Announces FDA Clearance to Market the Freedom Inguinal Hernia System in the United States