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Insightra Medical Launches the Freedom(TM) Ventral Hernia Repair, an Innovative New Way to Deploy Sublay Implants for Ventral Hernias Without Suturing
Date:12/3/2009

urgeon achieve the goal of broad mesh coverage.

The first generation of the system is aimed at open sublay repair, but by applying the system to biologic and anti-adhesion implants it could soon be used also for underlay techniques. Beyond open repair, the simple strap system and implantation procedure can be modified for laparoscopic placement, possibly making those procedures easier to perform.

The company conducted significant pre-clinical evaluations on the device to ensure it worked as designed. Following this, a pilot study of the device was conducted at the Ketteler Krankenhaus - Offenbach, Germany by Prof Paolucci and his team, together with Prof Amato. The results, with follow up were presented at the 4th International Hernia meeting in Berlin, a prestigious meeting between the European Hernia Society and the American Hernia Society.

“The initial results are very encouraging,” says Prof Amato. “We saw a marked reduction in time, the elimination of the need for suturing, much smaller incisions all while achieving a much wider coverage of the abdominal wall. Patient satisfaction is reported as very good. Up to date, in a mean follow up of 18 months, no recurrences are reported in the patient sample in which this newly developed prosthetic device has been implanted. It has encouraged us to expand the usage of the device in more centres throughout the world. While the follow up required is at least three years, we know the early advantages of a smaller incision and a much more rapid deployment are significant. We now need more experience to tell whether this is can become the gold standard for ventral hernia repair.”

Insightra Medical will make a limited launch of the product to select centres across Europe and Asia, with the intention to generate more clinical data on the system, before expanding to more commercial sites. Upon regulatory approvals, they will also start studies in select centres in
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