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article imageQ&A: New surgical repair mesh solution launched Special

By Tim Sandle     Oct 10, 2018 in Health
Chicago - A Chicago startup is bringing a new surgical mesh to the operating room, delivering a surgical repair solution that remains strong for just long enough before dissolving entirely. Medical student-turned entrepreneur Alexei Mlodinow explains more.
The new surgical meshes can be used in procedures like hernia repair are an all-too common source of surgical complications like infection and non-healing wounds, many of which develop more than a year after the surgery. Alexei’s journey to bringing that safer solution to market began in earnest at MATTER, Chicago’s health technology innovation hub. He founded startup medical device company, Surgical Innovation Associates (SIA), which recently received FDA 510(k) clearance for DuraSorb Monofilament MeshTM.
The DuraSorb Monofilament MeshTM is designed to integrate into a patient’s tissue, providing strong support as the body grows its own replacement tissue, and then slowly dissolving to leave the patient free from foreign material within one year. Digital Journal spoke with Alexei Mlodinow to find out more.
Digital Journal: To begin with, what is a surgical mesh?
Alexei Mlodinow: Think of surgical mesh as a piece of cloth that is compatible with the inner tissues of your body. Just like you might stitch in a piece of cloth to patch a hole or provide thicker lining to a jacket, you stitch in surgical mesh to reinforce weak or damaged tissue in various types of reconstructive and cosmetic surgery.
DJ: What have been some of the concerns with surgical meshes in the past?
Mlodinow: Most surgical meshes used today are permanent. It’s nice, in theory, to have permanent strength from a mesh that will remain in the body forever, but it’s not clear that is necessary in all types of procedures. What is clear in all types of procedures is that any mesh carries risk as long as it is in the body. Chronic pain, infection, and non-healing wounds can all occur, even 10 years or more after the original surgery.
DJ: Why are current plans for a surgical mesh for hernia repair controversial?
Mlodinow: Let’s be clear that there are several different types of hernias, and many techniques for repairing each one. In many of these cases, the use of surgical mesh is not only not controversial, but it’s the gold standard with proven benefits over repair without mesh. That said, a central question in today’s surgical community is “how long is long enough?” Can we see the benefits of a mesh repair without the long-term risks of leaving a foreign body in the patient forever?
DJ: What is DuraSorbTM?
Mlodinow: DuraSorbTM is a cutting edge new surgical mesh designed and manufactured by Surgical Innovation Associates (SIA) – a Chicago start-up company that spun out of Northwestern Feinberg School of Medicine and the patented work developed there by my clinical mentor, Dr. John Kim, Professor of Plastic Surgery. It is made of materials that have a 40+ year history of safe use in surgery as sutures to stitch wounds. If you’ve ever had absorbable stitches, think of it like we took those fibers and made them into a cloth. Realizing the deep need that existed for a “Goldilocks” surgical repair solution that remains strong for just long enough before dissolving entirely, I decided to focus on solving the problem by bringing DuraSorbTM from the pages of a surgeon’s patent to the operating room.
DJ: How does DuraSorbTM differ from conventional surgical meshes?
Mlodinow: DuraSorbTM has several clinical differentiators but the most important is its absorption profile. It was designed to be “there when you need it and gone when you don’t.” It retains strength for the initial, critical phases of wound healing, and then slowly disappears thereafter. It sticks around long enough for the patient’s own new tissue to grow around it, strengthening the wound even after the mesh has fully disintegrated, but alleviates some of the long-term risks to the patient.
DJ: How was DuraSorbTM developed?
Mlodinow: DuraSorbTM was invented by a renowned surgical mind at Northwestern, and designed by SIA with the input of a group of the most well-respected reconstructive plastic surgeons in the world. It was developed in partnership with a US-based supply chain of fully-integrated manufacturers who also have R&D capability. A thriving Chicago healthcare ecosystem, including a world-class incubator called MATTER, supported the remote development of the product without actually having to build out manufacturing facilities of our own.
DJ: What clinical trials have been undertaken?
Mlodinow: This is a safe material with a long history of use around the world, and the key innovation was its re-appropriation into DuraSorbTM. Robust preclinical testing demonstrated its performance and its safety, and supported US FDA clearance in August. Clinical trials will begin next year to prove the multiple devices we have in development to improve pre-pectoral breast reconstruction, minimally-invasive facelift, and other techniques.
DJ: What has been the response to DuraSorbTM from the medical profession?
Mlodinow: We’ve seen excitement about DuraSorbTM. Our conversations with surgeons, distributors, strategic partners, and others, have demonstrated the hunger for a new solution that decreases risks to patients while maintaining the efficacy of a given operation.
DJ: How are you promoting DuraSorbTM?
Mlodinow: We believe innovation and its dissemination should be clinician-driven with the latest and best evidence, so our capital expenditures are focused on running high-quality clinical trials whose results will do the talking. That said, we are at many surgical conferences to meet with interested surgeons and corporate partners, and are presenting our first abstract at the upcoming American College of Surgeons Clinical Congress 2018 in Boston.
More about surgical mesh, meshes, surgical techniques, Medical Technology
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