The start-up medical device company Surgical Innovation Associates (SIA) recently announced their first product to achieve FDA clearance, and it’s one that will be of high interest to healthcare professionals who have been watching the ongoing debate around surgical mesh.
DuraSorb Monofilament Mesh is the inaugural offering in a forecasted line of bioabsorbable products meant for reconstructive and cosmetic surgeries. SIA compares the product to an absorbable stitch, noting the DuraSorb surgical mesh provides the soft tissue support necessary for many surgeries, then slowly dissolves. The company reports there will be no sign of the DuraSorb mesh in a patient within one year of a procedure, other than the healthy new tissue that grew into and around it.
To learn more, Surgical Products interviewed Alexei Mlodinow, CEO of SIA.
Surgical Innovation Associates recently earned FDA clearance for DuraSorb Monofilament Mesh. What can you tell us about the product?
DuraSorb is a cutting edge new surgical mesh made of materials that already have a 35-plus 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 specialized cloth.
DuraSorb has several clinical differentiators from other meshes but the most important is its absorption profile, retaining strength for the initial, critical phases of wound healing, and then slowly disappearing thereafter.
There has been a lot of discussion about potential complications from surgical mesh in recent years. Was that part of the inspiration behind the development of DuraSorb?
Yes. 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 always necessary. 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, sometimes years after the original surgery. DuraSorb was created by a highly regarded surgeon at Northwestern, who had seen patients come in with some of these problems in a particularly vulnerable population of patients — those undergoing post-mastectomy breast reconstruction.
You describe the product as delivering a “Goldilocks” solution. What do you mean by that?
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?
The most commonly used meshes are long-term, lasting for years. There are some short-term absorbable meshes, but they go away in just a couple months, before the wound can fully heal. DuraSorb was designed to be “just right,” 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, alleviating some of the long-term risks to the patient.
In terms of practical use, what is DuraSorb like for the surgeons? How it similar to or different from what they’ve used previously?
The great thing about DuraSorb is that it’s a material very much like what surgeons have used in their training and in their practice. Surgeons can use DuraSorb in a similar way and realize the benefits that lie in the material. The physical handling characteristics — pliability, drapability, thickness, and so on — were optimized by a group of the most well-respected reconstructive plastic surgeons in the world, but the actual way the surgeon uses it is nothing new for him or her.
How does DuraSorb reflect the overall mission of SIA? Does this forecast other solutions you plan to develop and introduce in the future?
SIA is committed to using “for surgeon, by surgeon” innovation to bring better outcomes to patients and lower costs to reconstructive and cosmetic surgery. DuraSorb is a prime example of that, as are the multiple devices we have in development to improve pre-pectoral breast reconstruction, minimally-invasive facelift, and other techniques.
Is there anything else you’d like to add?
SIA’s proximity to industry, academia and world-leading healthcare institutions is reflected in its strong team and advisory board. This ecosystem is ideal for the rapid translation of concepts into novel devices that incorporate the voice of key stakeholders — regulators, insurers, providers, physicians, and, most importantly, patients.
Chicago’s MATTER, a hub for healthcare technology innovation, played a crucial role in the launch of SIA. It is our early corporate home and has helped connect us to the knowledge and skill sets needed to run a science-based venture.