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Insightra Medical Inc Gains CE Mark on the Freedom(TM) Inguinal Hernia Product Range
Date:2/25/2010
The unique design of the petals of the implant were developed to improve lateral grip, while protecting delicate structures such as the spermatic cord. Over 12 months of pre-clinical implantations have shown that the implant worked as designed - staying in place without fixation in all of the subjects.
But Freedom-I holds a second innovation within its unique design - improved tissue ingrowth. Detailed histological animal studies have looked at the ingrowth patterns and tissue quality with the new design of the implant. The gentle spring like motion of the implant ensures that during tissue ingrowth, the forces continuously change with the dynamic movement of the implant. This biomechanical action promotes tissue regeneration instead of the fibrotic scarring usually seen in conventional meshes. The ingrowth of elastic elements, connective tissue, new blood vessels and nerves within Freedom-I - has been experimentally demonstrated. The tissue ingrowth resembles the regeneration of the natural components of the abdominal wall.
“The ability of the implant to compress and then reopen has a marked effect on the way tissue grows inside it,” says Prof Amato. “Our experimentation has shown that we get an exceptionally high quality of tissue ingrowth starting very early on. That improved tissue structure is seen as far out as twelve months. As we predicted, the dynamic movement creates physiologic conditions that are different to static plugs or meshes. This viable, living barrier that grows in and around the implant does not suffer from the contraction and shrinkage often demonstrated with static hernia repair devices.”
Researchers hope that the elimination of fixation and the dynamic motion of the implant will translate into improved clinical outcomes. In a previous clinical trial, early hand made versions of the product were implanted in 67 patients which now have an average follow up of over four years. The results from
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