DURAMESH^TM BY MESH SUTURE INC.
The Next Generation of Surgical Sutures

Embedded in the records of surgical history, the story of sutures reveals a tradition dating back to Ancient Egypt, where linear threads made of hemp or animal intestines were used to close craniotomy incisions. Millennia have passed, yet sutures have remained largely unaltered until the demands of modern medicine, particularly the challenges posed by today’s larger patients and the need for faster recoveries, cast a revealing light on the inherent limitations of surgical sutures.

It was in the midst of this dire necessity that Dr. Dumanian was compelled to innovate. Dumanian is the founder of Mesh Suture Inc and the Chief of Plastic Surgery at Northwestern University’s Feinberg School of Medicine in Chicago. Instead of settling for the status quo in patient care, he invented Duramesh, a first-of-its-kind suture, as a creative outgrowth of grappling with the complications of standard sutures in laparotomy closure, hernia repair, and tendon surgery across plastic surgery, general surgery, and orthopedics.

“The design of Duramesh was born out of 28 years of hands-on surgical experience in my academic practice. We iterated and experimented until we found the winningdesign that met the exact standards I knew were essential for optimal surgical outcomes,” says Dr. Dumanian.

Despite incremental advancements such as the addition of tiny hooks on the linear suture element, the fundamental structure and function of sutures has remained relatively static.

The beginnings of Mesh Suture Inc.’s Duramesh technology can be traced back to Dr. Dumanian’s residency at Massachusetts General Hospital in Boston. Here, he was taught the “Superman” closure technique, which used a nylon suture to achieve abdominal closure under high tension, often resulting in cut fingers for surgeons due to the immense forces exerted. Meanwhile, he becamemore fascinated by the repercussions of tension on tissues, prompting him to reflect on the necessity for a remedy.

His training in Plastic Surgery and Hand Surgery further fueled his interest in suture pull-through, or “cheesewiring”, a known failure mode in delicate procedures like finger tendon repair. Drawing from his diverse surgical experience, he came up with the idea of a suture with mesh-like characteristics. After years of research, patent prosecution and regulatory submissions, Duramesh became available in the EU and UK in 2022, and in the US in 2023 .

Duramesh addresses tension concentration at the repair site while providing a scaffold for seamless tissue integration. Its defining element is its ingenious design, which combines the familiar handling properties of traditional sutures with the macroscopic porosity and elasticity of mesh material. This translates into tangible clinical benefits, meaning minimized suture pull-through via the absorption and diffusion of tension and a durable repair by facilitating optimal and fast tissue integration. Consequently, surgeons can now perform repairs that are both minimally invasive and maximally effective, ushering in a new era of surgical precision and patient care.

Nearly every branch of surgery can benefit from an improved internal suture. From abdominal surgery to urology, gynecology, colorectal surgery, trauma surgery, and transplant surgery, the demand for enhanced suturing techniques is universal. Orthopedics may stand to benefit the most. In orthopedic procedures like tendon repairs, the challenge of suture cheese-wiring often necessitates prolonged immobilization through splints and casts leading to joint stiffness and limited range of motion. Yet, with a superior suture that provides enhanced early repair strength, the need for extended immobilization can be reduced considerably. Consider the case of Kevin Durant, an NBA player whose Achilles tendon rupture sidelined himfor 552 days. With enhanced suturing technology, such lengthy recoveries could become a thing of the past, providing patients a faster path to rehabilitation.

Transformative Tissue Repair

Duramesh, the first and only mesh suture, redefines the landscape of surgical sutures by offering a transformative solution for tissue repair. Comprised of multiple polypropylene sutures intricately woven together, it embodies strength, elasticity, and structural integrity. Its proprietary braiding pattern creates a macroporous cylindrical mesh structure that complies with United States Pharmacopeial Convention (USP) standards for suture tensile strength while creating a hollow core within the mesh scaffold to facilitate tissue integration.

During implantation, Duramesh addresses suture pull-through, a ubiquitous surgical failure mode. By absorbing and diffusing tension, it minimizes the risk of pull-through at two failure points—along the suture line and at the suture-tissue interface. Its elasticity enables it to elongate and flatten like a ribbon along the suture line, distributing the tension across its multiple filaments. This reduces tension-induced tissue trauma and enhances the overall integrity of the surgical repair.

Following implantation, Duramesh continues to play a vital role in the healingprocess by facilitating fibrovascular tissue formation around its filaments and within its hollow core. The integration process effectively anchors Duramesh into the surrounding tissue, further reinforcing the strength of the surgical repair over time.

“Our product fills a crucial gap as patients demand quicker recoveries and surgeons seek to minimize complications,” says Dr. Dumanian. “Its rapid adoption globally and in the U.S. speaks volumes about its appeal and effectiveness. At my institution alone, over 800 cases were performed with Duramesh in the first 12 months of product availability. Published data for the first 6 of these 12 months shows 56 surgeons across 12 surgical subspecialties closed with Duramesh.”

Incorporating Duramesh into surgical procedures offers distinct advantages over traditional sutures, enhancing both the strength and simplicity of tissue repair.

According to research, by day 8, Duramesh repairs are twice as strong as those performed with standard sutures. Duramesh also exhibits remarkable resistance to cheesewiring in various models, with 55 percent greater resistance to cheesewiring in a porcine abdominal wall model and 100 percent stronger resistance to cheesewiring in a human finger tendon model. Its elasticity, which is at least 75 percent greater than that of standard sutures, further reduces the likelihood of cheesewiring.

Beyond its superior performance, Duramesh offers a frictionless integrationinto existing surgical techniques. Its simple, elegant design enables surgeons to continue using their current approach, with device deployment similar to that of traditional sutures in terms of material, handling, and technique.

Surgeons can choose from a wide range of Duramesh sizes and needles. For delicate procedures, sizes like 2-0 and 0, with diameters ranging from 1.5mm to 2.6mm, are available, while larger sizes 1 and 2, ranging from 3.9mm to 4.1mm, offer a robust scaffold for hernia repairs and orthopedic reconstruction. Additionally, Duramesh provides options with both small and large needles, ensuring flexibility and customization in open and minimally invasive surgery. Each box contains 5 units of the selected size, guaranteeing an ample supply for surgical procedures.

Enhancing Surgical Outcomes

Mesh Suture Inc. thrives as a collaborative effort led by and for surgeons. This not only ensures the relevance and efficacy of Mesh Suture Inc.’s solutions but also fosters a deep sense of trust and understanding among its users. Surgeons have embraced the company’s products for their ability to streamline procedures, enhance patient outcomes, and minimize complications.

Dr. Ryan Conway, a general surgery specialist based in Grand Rapids, MI, exemplifies Duramesh’s optimal results through his experience, which began approximately five to six years ago following a complication in a ventral hernia repair. Introduced to Duramesh suture, he was immediately intrigued by its potential to assist in abdominal wall closure. Over time, attending conferences and maintaining contact with experts led Dr. Conway to eagerly adopt the Duramesh suture.

Similarly, Dr. Eric Pauli from the Penn State Health System was introduced to Duramesh and immediately recognized its alignment with the issue of suture pull-through. Initially applied to medium-sized hernias in patients unsuitable for traditional mesh or at risk of recurrence, Duramesh proved indispensable in complex surgeries where traditional mesh placement was impractical. Dr. Pauli underscores Duramesh’s ability to delay hernia formation and facilitate smoother recoveries, while also highlighting its potential in emergency surgeries to mitigate hernia risks.

Our Product Fills A Crucial Gap As Patients Demand Quicker Recoveries And Surgeons Seek To Minimize Complications. Its Rapid Adoption Globally And In The U.S. Speaks Volumes About Its Appeal And Effectiveness

In a similar vein, Dr. Luis Garcia from the University of Iowa Hospitals and Clinics emphasizes Duramesh’s advantages in closing small to moderate hernias without extensive mesh placement. He commends Duramesh’s leaders for their openness to share insights and collaborate, which has significantly eased the adoption process. Envisioning a broader market for Duramesh as surgeon awareness grows, Dr. Garcia anticipates its efficacy and the company’s collaborative approach driving further adoption.

Stitching Together a Global Surgical Transformation

Mesh Suture Inc.’s global presence speaks volumes about the universal impact of its Duramesh device, with a reach that spans continents. Since its FDA approval in September 2022, Mesh Suture Inc. has quickly gained traction in the U.S. Its clinical adoption commenced in January 2023, paving the way for a paradigm shift in surgical practices. Venturing outside borders, Mesh Suture Inc. has also found success in the United Kingdom, Europe, the Middle East, and Mexico.

Mesh Suture Inc.’s journey extends beyond geographical boundaries, resonating deeply with surgeons in medical institutions in the US and abroad. Surgeons in these centers, often at the forefront of medical research and education, play an important role in shaping the future of surgical practices. As such, Mesh Suture Inc. recognizes the criticality of independent clinical validation and supports multiple surgeon-investigator-led clinical studies at arm’s length across the globe. “Let the data speak for itself”, says Dr. Dumanian.

Additionally, Mesh Suture Inc. is actively engaged in the development of new products. Excitingly, exploration has begun into shorter lengths of Duramesh for minimally invasive surgery, kits for orthopedics, a looped end feature, as well as an absorbable version of Duramesh.

Backing pioneering initiatives like these are Mesh Suture Inc.’s diverse professionals, who work under female management. The team includes regulatory experts, engineers, and progressive leadership. Their collective expertise has propelled Mesh Suture Inc. to the forefront of the industry, setting new standards for surgical excellence.

Today, Duramesh’s global availability is a testament to its widespread acceptance by the surgical community, offering a simple and elegant solution to the limitations posed by traditional sutures. As modern clinical innovations continue to evolve, Duramesh raises the standard of surgical suturing, one precise yet resilient stitch at a time. Through its transformative design and the patient-centered vision that catalyzed its creation, this pioneering suture company embodies the pursuit of excellence that propels medical advancements collaboratively beyond the current frontiers of patient care.