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Insightra Medical Inc Gains CE Mark on the Freedom(TM) Inguinal Hernia Product Range

Insightra Medical Inc Announced Today the CE Mark and Immediate Release of Their New Inguinal Hernia Product Range Freedom-I, with an Aim to Improve Surgical Outcomes and Take Significant Market Share in an Estimated $300 Million Worldwide Market.

(PRWEB) February 25, 2010 -- Insightra Medical is highly focused on bringing innovations to the field of medical devices. For the past four years they have been developing an exciting new product to address many of the complications associated with inguinal hernia such as pain, discomfort, hematoma and recurrence.

Freedom Inguinal is a next generation of inguinal prosthetics, designed to simplify the operative procedure, reduce the need for fixation and improve tissue ingrowth. A team of engineers working closely with Prof Amato, an expert of abdominal wall diseases and inventor of the device, have been refining the geometry of the implant to help absorb the forces that normally expel devices while also increasing lateral gripping forces helping to hold it in place. Although the implant can be optionally fixed in place, pre-clinical experimentation has shown that these newly developed implants remained in place with no need for point fixation.

“Eliminating suturing or tacking of inguinal implants is a very important goal,” says Prof Amato, a general surgeon from Palermo, Italy. “Many of the complications we see in hernia are a result of excessive dissection and then passing needles and suture through very delicate structures in the groin, often damaging blood vessels or nerves. Our aim was to reduce the need to fix implants in the groin.”

Historically, implants needed to be fixed in place to stop the pressure inside the abdomen from dislodging them. The focus of Freedom-I has been to design an implant that reduces the impact of the expulsion forces, like a shock absorber, so reducing the need for fixation. 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 that trial are very positive demonstrating a simplified operative procedure, decreased complication rates and, to date, no recurrences. The results of that trial are soon to be published.

Insightra Medical intends a controlled release of the product across Europe and Asia as part of a broader clinical trial to collect more outcome data.

About Insightra:
Insightra Medical Inc is a privately owned medical device company based in Irvine California. They are focused on three strategic areas – General, uro-gynecological and cardiovascular therapies.


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Insightra Medical Inc Gains CE Mark on the Freedom(TM) Inguinal Hernia Product Range
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