The initial results are very encouraging
Irvine, CA (PRWEB) December 3, 2009
Insightra Medical, Inc, a California based medical device company today announced the launch of its new ventral hernia repair system. Freedom Ventral is a modification to the standard sublay technique, which completely obviates the need for complex, time consuming mesh suturing.
Ventral hernia is a common type of hernia affecting the abdominal wall, often presenting as major bulges through old incisional scars. Classic repairs using sutures are notorious for having high recurrence rates, and chronic pain. This has provoked the surgical community to look for new ways of reinforcing the wall using meshes or other prosthesis.
The most widely performed repair method is known as the sublay technique according to Rives, where a mesh is placed beneath the abdominal muscles but above the peritoneum. This method is thought to have merit as it uses the pressure of the abdominal contents to actually push the implant against the underside of the abdominal wall, holding it in place. But this is not an easy technique. In order to make sure the mesh does not dislodge after surgery during the first few days or later, many sutures are placed around the edge of the mesh to “tack” it in place. Trying to place these sutures can be difficult due to lack of space and vision, plus the close proximity of blood vessel and nerves.
“These sutures can be a problem,” says Prof G Amato of the University of Palermo - Italy. “You need a larger incision to see where to safely place the sutures in periphery of the abdominal wall. Even then it is difficult to get them in the far lateral space due to lack of access. This can result in several problems such as the mesh not being placed widely enough, bleeding and pain. More so, if the mesh is put under a lot of force, the sutures can be pulled out causing more problems.”
Another issue in incisional hernia repair is how to achieve an adequate overlap of the mesh over the defect edges. An insufficient overlap of the mesh is unanimously considered as the major cause of recurrence.
Insightra Medical has been developing a system that would eliminate the need for complex suturing, yet give reliable, repeatable fixation of the mesh during the crucial initial healing phase. They designed a mesh implant with a difference. The mesh (manufactured by Assut Europe SpA) has a body similar to a standard implant, but radiating from the body are eight arms made of the same mesh material. Called Octomesh(tm), this implant is held in place by the mesh arms being quickly and simply tunnelled through the muscles of the abdominal wall, requiring no sutures or tacks. The eight arms can be placed in a matter of minutes and even adjusted once the fascia has been closed - an advantage over other methods of repair.
“The use of mesh straps to hold implants in place is nothing new,” says Steve Bell, President of Insightra Medical and co-inventor of the new system. “They have been used in sub urethral sling procedures and prolapse procedures for over a decade. We have invented a way to use that tried and tested technique in ventral hernia surgery.”
One major advantage of this system is the ability to place the straps at the lateral extremes of the abdomen where traditionally it would be difficult to place sutures. This allows for a very broad placement of mesh in a tension free way. The strap system of the Octomesh™ is designed to allow a wide yet simple coverage of the abdominal wall, away from the edges of the hernia opening. This helps the surgeon 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 the United States.
This product is CE marked. Not available in the USA.
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