Overview

Suturable Mesh combines the desirable principles of a mesh repair with the placement precision of a suture

Overview

Suturable Mesh combines the desirable principles of a mesh repair with the placement precision of a suture

The Problem

Sutures can cut through otherwise intact tissue due to the presence of a sharp leading edge - described as "suture pull-through" or "cheese-wiring" - leading to repair failure.

Meshes better distribute forces to limit tissue tearing, but they introduce their own complications, such as chronic pain, adhesions, fistulas, migration, and infection.

A device is needed that both distributes forces without introducing mesh-related complications.

Sutures Can Cut Intact Tissue

Over the past 50 years, nearly all surgical specialties have made significant technological advancements aimed at increasing surgical efficiency, reducing morbidity, and improving patient outcomes. However, one critical and ubiquitous technology, the surgical suture, has remained relatively unchanged.

Every year, surgeons rely on millions of traditional sutures to securely approximate muscle, fascia, and tendons during the critical wound healing period. And each year hundreds of thousands of sutures fail, ripping through the very tissues they are supposed to hold thereby causing primary incisional hernias, recurrent hernias, dehiscence, eviscerations, and tendon ruptures/adhesions.

The clinical, economic, and reputational implications of these surgical failures can leave patients, physicians, and institutions feeling uncertain about the reliability of their surgical closures.

A Best of Both Worlds Solution - Suturable Mesh

Suturable Mesh combines the desirable principles of a mesh repair with the placement precision of a suture. It is the world's only device that both approximates tissue and permits ingrowth for a stronger, earlier repair.3

Clinical Implications

Between 22%1 and 52%2 of patients will develop an incisional hernia at 3 years and 1 year post-op, respectively. The failure rate for hernia repairs is even higher, with 63%3 of hernias repaired with sutures failing at 10 years. These surgical failures exact a heavy toll on patients, potentially reducing their quality of life and increasing the risk of bowel complications. Orthopedic repairs fail too, with massive rotator cuff repairs failing 39.2%4 of the time.

Economic Implications

Each year, the US health system spends billions of dollars to address incisional hernias, hernia recurrences, and tendon ruptures and/or adhesions, along with associated complications and treatments.

Reputational Implications

As patients become more medically literate and share their experiences, the potential for reputational risk increase - physicians and institutions with subpar patient outcomes may be at risk.

The current standard of care for tissue repairs is failing - surgeons need a simple, elegant alternative in their armamentarium to help them securely close surgical defects with confidence, and patients deserve more reliable surgical outcomes.

Innovative Design to Distribute Forces

Duramesh's patented design has more surface area than standard sutures to distribute forces and reduce suture pull-through.1 Unlike standard sutures, Duramesh flattens to better distribute forces at the suture-tissue interface.2 

A Simple, Elegant Alternative

Duramesh™ is the only wound closure device that minimizes the concentration of tension at the suture-tissue interface and facilitates tissue integration7,8 to help surgeons close tissue defects securely and confidently.  

Our indication is broad, giving us the opportunity to help surgeons and patients across a wide range of surgical procedures. Our surgical community is rapidly growing: to date we have deployed over 6,000 Duramesh™ mesh sutures worldwide, have over 100 surgeon advocates, and have 6 ongoing trials generating evidence to demonstrate the impact that Duramesh™ can have on surgical outcomes.

Strong from the Start

Allows Tissue Incorporation2

Duramesh's filaments flatten parallel to the incision, and its open-walled, hollow core design allows tissue incorporation into the device during healing.

  • Duramesh™ has up to 9x more surface area than traditional suture to minimize suture pull-through during early stages of wound healing5
  • At Day 8, Duramesh™ repairs are 2x stronger than standard suture repairs6
  • Duramesh™ had 45% greater resistance to pull-through versus standard suture in a large porcine abdominal wall model9
  • Duramesh™ had 100% greater resistance to pull-through vs standard suture in a human finger tendon model (see Figure: Static Testing)7
  • Duramesh™ is at least 75% more elastic than standard suture to reduce suture pull-through7

Durable Over Time

Duramesh™ has a hollow, macroporous structure of fine filaments that integrates into muscle, fascia, and/or tendon to create a strong and durable repair.10,12

  • Complete tissue integration by day 90 maintains repair strength to create a reliable repair10
  • Pore size > 1 mm2 post-implantation facilitates tissue integration5

Simple Surgical Technique11

A simple, elegant design allows surgeons to maintain their current technique - device deployment is similar to that of traditional suture in material, handling, and technique.

  • A comprehensive portfolio of suture sizes and needles allow surgeons to use the same suturing technique
  • Knot tying is the same as with standard suture - at least 4 alternating throws (2 square knots) with 1 or 2 extra throws for security

Laparotomy with
Duramesh™ Mesh Suture

A Stronger, Earlier Repair3

Repairs with Duramesh revealed less gap formation and more intact repairs in comparison to conventional sutures in an in-vivo rabbit tendon model. Duramesh repairs were twice as strong as standard suture at two weeks.

Clinical Implications

Between 22%1 and 52%2 of patients will develop an incisional hernia at 3 years and 1 year post-op, respectively. The failure rate for hernia repairs is even higher, with 63%3 of hernias repaired with sutures failing at 10 years. These surgical failures exact a heavy toll on patients, potentially reducing their quality of life and increasing the risk of bowel complications. Orthopedic repairs fail too, with massive rotator cuff repairs failing 39.2%4 of the time.

Economic Implications

Each year, the US health system spends billions of dollars to address incisional hernias, hernia recurrences, and tendon ruptures and/or adhesions, along with associated complications and treatments.

Reputational Implications

As patients become more medically literate and share their experiencs, the potential for reputational risk increase - physicians and institutions with subpar patient outcomes may be at risk.

The current standard of care for tissue repairs is failing - surgeons need a simple, elegant alternative in their armemtaria to help them securely close surgical defects with confidence, and patients deserve more reliable surgical outcomes.

A Simple, Elegant Alternative

Duramesh™ is the only wound closure device that minimizes the concentration of tension at the suture-tissue interface and facilitates tissue integration to help surgeons close tissue defects securely and confidently.  

Our indication is broad, giving us the opportunity to help surgeons and patients across a wide range of surgical procedures. Our surgical community is rapidly growing: to date we have deployed over 6,000 Duramesh mesh sutures worldwide, have over 100 surgeon advocates, and have 6 ongoing trials generating evidence to demonstrate the impact that Duramesh can have on surgical outcomes.

Strong from the Start

- Duramesh has up to 9x more surface area than traditional suture to minimize suture pull-through during early stages of wound healing5

- At Day 8, Duramesh repairs are 2x stronger than standard suture repairs6

- Duramesh had 55% greater resistance to pull-through versus standard suture in a large porcine abdominal wall model

- Duramesh had 100% greater resistance to pull-through vs standard suture in a human finger tendon model7

  • - Duramesh is at least 75% more elastic than standard suture to reduce suture pull-through7

 

Simple Surgical Technique

A simple, elegant design allows surgeons to maintain their current technique - device deployment is similar to that of traditional suture in material, handling, and technique.

- A comprehensive portfolio of suture sizes and needles allow surgeons to use the same suturing technique
- Knot tying is the same as with standard suture - at least 4 alternating throws (2 square knots) with 1 or 2 extra throws for security

Laparotomy with
Duramesh™ Mesh Suture

References

1. Incisional Hernia Rate 3 Years after Midline Laparotomy

C Fink, P Baumann, M N Wente, P Knebel, T Bruckner, A Ulrich, J Werner, M W Büchler, M K Diener, Incisional hernia rate 3 years after midline laparotomy, British Journal of Surgery, Volume 101, Issue 2, January 2014, Pages 51–54, https://doi.org/10.1002/bjs.9364

2. Incisional Hernia Rates following Midline Laparotomy in the Obese Patient: a Retrospective Review

Wehrle CJ, Shukla P, Miller BT, Blake KE, Prabhu AS, Petro CC, Krpata DM, Beffa LR, Tu C, Rosen MJ. Incisional hernia rates following midline laparotomy in the obese patient: a retrospective review. Hernia. 2023 Jun;27(3):557-563. doi: 10.1007/s10029-022-02688-6. Epub 2022 Nov 1. PMID: 36318389.

3. Long-Term Follow-Up of a Randomized Controlled Trial of Suture versus Mesh Repair of Incisional Hernia

Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004 Oct;240(4):578-83; discussion 583-5. doi: 10.1097/01.sla.0000141193.08524.e7. PMID: 15383785; PMCID: PMC1356459.

4. Long-Term Outcomes of Massive Rotator Cuff Tear Repair: A Systematic Review

Shah NS, Suriel Peguero E, Umeda Y, Crawford ZT, Grawe BM. Long-Term Outcomes of Massive Rotator Cuff Tear Repair: A Systematic Review. HSS J. 2022 Feb;18(1):130-137. doi: 10.1177/15563316211008137. Epub 2021 Apr 15. PMID: 35087343; PMCID: PMC8753535.

5. Internal Product Testing

6. Experimental Study of the Characteristics of a Novel Mesh Suture 

G A Dumanian, A Tulaimat, Z P Dumanian, Experimental study of the characteristics of a novel mesh suture, British Journal of Surgery, Volume 102, Issue 10, September 2015, Pages 1285–1292, https://doi.org/10.1002/bjs.9853

7. Biomechanical Properties of a Novel Mesh Suture in a Cadaveric Flexor Tendon Repair Model 

Wallace SJ, Mioton LM, Havey RM, Muriuki MG, Ko JH. Biomechanical Properties of a Novel Mesh Suture in a Cadaveric Flexor Tendon Repair Model. J Hand Surg Am. 2019 Mar;44(3):208-215. doi: 10.1016/j.jhsa.2018.11.016. Epub 2019 Jan 16. PMID: 30660397.

8. Advances, Challenges, and Prospects for Surgical Suture Materials

Yiran Li, Qi Meng, Shaojuan Chen, Peixue Ling, Mitchell A. Kuss, Bin Duan, Shaohua Wu, Advances, challenges, and prospects for surgical suture materials, Acta Biomaterialia, Volume 168, 2023, Pages 78-112,ISSN 1742-7061,

9. [Mesh Suture] Better Resists Early Laparotomy Failure in a Cyclic Ball-Burst Model

Scheiber CJ, Kurapaty SS, Goldman SM, Dearth CL, Liacouras PC, Souza JM. Suturable mesh better resists early laparotomy failure in a cyclic ball-burst model. Hernia. 2020 Jun;24(3):559-565. doi: 10.1007/s10029-020-02133-6. Epub 2020 Feb 10. PMID: 32040788.

10. [Mesh Suture] Demonstrates Improved Outcomes over Standard Suture in a Porcine Laparotomy Closure Model

Dumanian GA. Suturable Mesh Demonstrates Improved Outcomes over Standard Suture in a Porcine Laparotomy Closure Model. Plast Reconstr Surg Glob Open. 2021 Oct 15;9(10):e3879. doi: 10.1097/GOX.0000000000003879. PMID: 34667699; PMCID: PMC8519206.

11. Duramesh Registry Study: Short-Term Outcomes using mesh suture for Abdominal Wall Closure

Hackenberger PN, Mittal M, Fronza J, Shapiro M. Duramesh registry study: short-term outcomes using mesh suture for abdominal wall closure. Front Surg. 2024 Jan 11;10:1321146. doi: 10.3389/fsurg.2023.1321146. PMID: 38274351; PMCID: PMC10809794.

12. Novel Mesh Suture Versus Traditional Suture-Based Repair in a Rabbit Tendon Model

Janes LE, Mioton LM, Fracol ME, Ko JH. An In Vivo Comparison: Novel Mesh Suture Versus Traditional Suture-Based Repair in a Rabbit Tendon Model. J Hand Surg Glob Online. 2021 Nov 19;4(1):32-39. doi: 10.1016/j.jhsg.2021.10.003. PMID: 35415598; PMCID: PMC8991626.

Sutures Can Cut Intact Tissue

Over the past 50 years, nearly all surgical specialties have made significant technological advancements aimed at increasing surgical efficiency, reducing morbidity, and improving patient outcomes. However, one critical and ubiquitous technology, the surgical suture, has remained relatively unchanged.

Every year, surgeons rely on millions of traditional sutures to securely approximate muscle, fascia, and tendons during the critical wound healing period. And each year hundreds of thousands of sutures fail, ripping through the very tissues they are supposed to hold thereby causing primary incisional hernias, recurrent hernias, dehiscence, eviscerations, and tendon ruptures/adhesions.

The clinical, economic, and reputational implications of these surgical failures can leave patients, physicians, and institutions feeling uncertain about the reliability of their surgical closures.

The Problem

Sutures can cut through otherwise intact tissue due to the presence of a sharp leading edge - described as "suture pull-through" or "cheese-wiring" leading to repair failure.

Meshes better distribute forces to limit tissue tearing, but they introduce their own complications, such as chronic pain, adhesions, fistulas, migration, and infection.

A Best of Both Worlds Solution - Suturable Mesh

Suturable Mesh combines the desirable principles of a mesh repair with the placement precision of a suture.

Clinical Implications

Between 22%1 and 52%2 of patients will develop an incisional hernia at 3 years and 1 year post-op, respectively. The failure rate for hernia repairs is even higher, with 63%3 of hernias repaired with sutures failing at 10 years. These surgical failures exact a heavy toll on patients, potentially reducing their quality of life and increasing the risk of bowel complications. Orthopedic repairs fail too, with massive rotator cuff repairs failing 39.2%4 of the time.

Economic Implications

Each year, the US health system spends billions of dollars to address incisional hernias, hernia recurrences, and tendon ruptures and/or adhesions, along with associated complications and treatments.

Reputational Implications

As patients become more medically literate and share their experiences, the potential for reputational risk increase - physicians and institutions with subpar patient outcomes may be at risk.

Innovative Design to Distribute Forces

Duramesh's patented design has more surface area than standard sutures to distribute forces and reduce suture pull-through.1 

The current standard of care for tissue repairs is failing - surgeons need a simple, elegant alternative in their armamentarium to help them securely close surgical defects with confidence, and patients deserve more reliable surgical outcomes.

A Simple, Elegant Alternative

Allows Tissue Incorporation2

Duramesh's filaments flatten parallel to the incision, and its open-walled, hollow core design allows tissue incorporation into the device during healing.

Duramesh™ is the only wound closure device that minimizes the concentration of tension at the suture-tissue interface and facilitates tissue integration7,8,11 to help surgeons close tissue defects securely and confidently.  

Our indication is broad, giving us the opportunity to help surgeons and patients across a wide range of surgical procedures. Our surgical community is rapidly growing: to date we have deployed over 6,000 Duramesh mesh sutures worldwide, have over 100 surgeon advocates, and have 6 ongoing trials generating evidence to demonstrate the impact that Duramesh can have on surgical outcomes.

Allows Tissue Incorporation2

Duramesh's filaments flatten parallel to the incision, and its open-walled, hollow core design allows tissue incorporation into the device during healing.

Strong from the Start

  • Duramesh™ has up to 9x more surface area than traditional suture to minimize suture pull-through during early stages of wound healing5
  • At Day 8, Duramesh™ repairs are 2x stronger than standard suture repairs6
  • Duramesh™ had 45% greater resistance to pull-through versus standard suture in a large porcine abdominal wall model9
  • Duramesh™ had 100% greater resistance to pull-through vs standard suture in a human finger tendon model (see Figure: Static Testing)7
  • Duramesh™ is at least 75% more elastic than standard suture to reduce suture pull-through7

Durable Over Time

Duramesh™ has a hollow, macroporous structure of fine filaments that integrates into muscle, fascia, and/or tendon to create a strong and durable repair10,12
  • Complete tissue integration by day 90 maintains repair strength to create a reliable repair10
  • Pore size > 1 mm2 post-implantation facilitates tissue integration5

 

Simple Surgical Technique11

A simple, elegant design allows surgeons to maintain their current technique - device deployment is similar to that of traditional suture in material, handling, and technique.

  • A comprehensive portfolio of suture sizes and needles allow surgeons to use the same suturing technique
  • Knot tying is the same as with standard suture - at least 4 alternating throws (2 square knots) with 1 or 2 extra throws for security

Laparotomy with
Duramesh™ Mesh Suture

References

1. Incisional Hernia Rate 3 Years after Midline Laparotomy

C Fink, P Baumann, M N Wente, P Knebel, T Bruckner, A Ulrich, J Werner, M W Büchler, M K Diener, Incisional hernia rate 3 years after midline laparotomy, British Journal of Surgery, Volume 101, Issue 2, January 2014, Pages 51–54, https://doi.org/10.1002/bjs.9364

2. Incisional Hernia Rates following Midline Laparotomy in the Obese Patient: a Retrospective Review

Wehrle CJ, Shukla P, Miller BT, Blake KE, Prabhu AS, Petro CC, Krpata DM, Beffa LR, Tu C, Rosen MJ. Incisional hernia rates following midline laparotomy in the obese patient: a retrospective review. Hernia. 2023 Jun;27(3):557-563. doi: 10.1007/s10029-022-02688-6. Epub 2022 Nov 1. PMID: 36318389.

3. Long-Term Follow-Up of a Randomized Controlled Trial of Suture versus Mesh Repair of Incisional Hernia

Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004 Oct;240(4):578-83; discussion 583-5. doi: 10.1097/01.sla.0000141193.08524.e7. PMID: 15383785; PMCID: PMC1356459.

4. Long-Term Outcomes of Massive Rotator Cuff Tear Repair: A Systematic Review

Shah NS, Suriel Peguero E, Umeda Y, Crawford ZT, Grawe BM. Long-Term Outcomes of Massive Rotator Cuff Tear Repair: A Systematic Review. HSS J. 2022 Feb;18(1):130-137. doi: 10.1177/15563316211008137. Epub 2021 Apr 15. PMID: 35087343; PMCID: PMC8753535.

5. Internal Product Testing

6. Experimental Study of the Characteristics of a Novel Mesh Suture 

G A Dumanian, A Tulaimat, Z P Dumanian, Experimental study of the characteristics of a novel mesh suture, British Journal of Surgery, Volume 102, Issue 10, September 2015, Pages 1285–1292, https://doi.org/10.1002/bjs.9853

7. Biomechanical Properties of a Novel Mesh Suture in a Cadaveric Flexor Tendon Repair Model 

Wallace SJ, Mioton LM, Havey RM, Muriuki MG, Ko JH. Biomechanical Properties of a Novel Mesh Suture in a Cadaveric Flexor Tendon Repair Model. J Hand Surg Am. 2019 Mar;44(3):208-215. doi: 10.1016/j.jhsa.2018.11.016. Epub 2019 Jan 16. PMID: 30660397.

8. Advances, challenges, and prospects for surgical suture materials

Yiran Li, Qi Meng, Shaojuan Chen, Peixue Ling, Mitchell A. Kuss, Bin Duan, Shaohua Wu, Advances, challenges, and prospects for surgical suture materials, Acta Biomaterialia, Volume 168, 2023, Pages 78-112,ISSN 1742-7061,

9. [Mesh Suture] Better Resists Early Laparotomy Failure in a Cyclic Ball-Burst Model

Scheiber CJ, Kurapaty SS, Goldman SM, Dearth CL, Liacouras PC, Souza JM. Suturable mesh better resists early laparotomy failure in a cyclic ball-burst model. Hernia. 2020 Jun;24(3):559-565. doi: 10.1007/s10029-020-02133-6. Epub 2020 Feb 10. PMID: 32040788.

10. [Mesh Suture] Demonstrates Improved Outcomes over Standard Suture in a Porcine Laparotomy Closure Model

Dumanian GA. Suturable Mesh Demonstrates Improved Outcomes over Standard Suture in a Porcine Laparotomy Closure Model. Plast Reconstr Surg Glob Open. 2021 Oct 15;9(10):e3879. doi: 10.1097/GOX.0000000000003879. PMID: 34667699; PMCID: PMC8519206.

11. Duramesh Registry Study: Short-Term Outcomes using mesh suture for Abdominal Wall Closure

Hackenberger PN, Mittal M, Fronza J, Shapiro M. Duramesh registry study: short-term outcomes using mesh suture for abdominal wall closure. Front Surg. 2024 Jan 11;10:1321146. doi: 10.3389/fsurg.2023.1321146. PMID: 38274351; PMCID: PMC10809794.

12. Novel Mesh Suture Versus Traditional Suture-Based Repair in a Rabbit Tendon Model

Janes LE, Mioton LM, Fracol ME, Ko JH. An In Vivo Comparison: Novel Mesh Suture Versus Traditional Suture-Based Repair in a Rabbit Tendon Model. J Hand Surg Glob Online. 2021 Nov 19;4(1):32-39. doi: 10.1016/j.jhsg.2021.10.003. PMID: 35415598; PMCID: PMC8991626.