First US Patient Implanted in Pivotal IDE Study of DuraSorb® Monofilament Mesh Use in Prosthetic Breast Reconstruction

First study designed to support marketing authorization of a surgical mesh for use in breast reconstruction

CHICAGO–(BUSINESS WIRE)–SIA (Surgical Innovation Associates), an early growth-stage medical technology company, announced today that the first patient has been enrolled in a pivotal trial of its flagship absorbable mesh, DuraSorb®, under an investigational device exemption (IDE) from the United States Food and Drug Administration (US FDA). The study will evaluate the safety and effectiveness of DuraSorb® for reinforcement in prosthetic breast reconstruction.

The product is made from a biocompatible synthetic material to provide mechanical support and scaffolding during the early months of wound healing and scar formation, followed by gradual absorption, which is generally complete by one year.1-4 While DuraSorb® received a CE mark for reconstructive and aesthetic breast surgery last year, no mesh product, DuraSorb or otherwise, currently has approval from the US FDA for breast reconstruction. Despite this, prosthetic breast reconstruction is most often performed with costly biologic mesh derived from the skin of human cadavers.5-7DuraSorb® is designed to provide the same type of support during breast reconstruction, without requiring any cadaveric or animal derived tissue.

“As plastic surgeons, we have been using processed human skin in breast surgery for over 15 years,” said Dr. Mihye Choi, an Associate Professor at New York University Hansjorg Wyss Department of Plastic Surgery, and the first principal investigator to enroll a patient in SIA’s pivotal study. “ADM has its benefits, but I am excited to use a non-biologic alternative that has been evaluated by the FDA for this specific purpose.”

The importance of this work is recognized by the National Cancer Institute, which is partially funding the clinical trial through the Small Business Innovation Research Program. In addition, the IDE study was approved by Centers for Medicare and Medicaid, which will allow Medicare beneficiaries access to the trial.

“After years of collaborative work with FDA on a study design, we are honored to initiate this trial with some leading minds in the field of plastic surgery,” said Dr. Alexei Mlodinow, President and CEO of SIA. “This work will move the field forward, with important implications for a population of women who are going through enough as it is following a diagnosis of breast cancer and the need for a mastectomy.”

About Surgical Innovation Associates (SIA)

Founded in Chicago in 2016, SIA has since advanced the DuraSorb® product family from ideation through FDA 510k clearance and into the operating room. The company is pursuing investigation and development of additional products and indications for breast reconstruction and facial aesthetic applications, among others. Use of DuraSorb®, like any implantable medical device, carries risk of complications that may arise from the surgical implantation procedure or from the device itself. A full list of Warnings and Precautions is available in the Instructions for Use documents for US and EU surgeons. In the United States, the device has been cleared only for soft tissue support and remains investigational for specific applications in breast reconstruction and aesthetics.

Learn more at SIA.health.

References:

  1. Clinical data on file. Study 19-002: Real-World Application of DuraSorb™ Monofilament Mesh: An Open-Label Registry Study of Soft Tissue Support in General and Plastic Surgery.
  2. Mlodinow A.S., Kuzycz M., Hasse M., Cruikshank T., Wiegel S.W., & Vazquez R.. (October, 2018). Proof-of-Concept Use of Novel Biosynthetic Scaffold in a Porcine Model of Abdominal Wall Repair Oral Presentation presented at: American College of Surgeons Congress 2018; Boston, MA, USA.
  3. Mlodinow AS, Kuzycz M, Hasse M, Cruikshank T, Wiegel SW, Ellis MF, & Kim JYS. (May, 2019). Biomechanical and Histologic Evaluation of a Novel Absorbable Mesh in a Porcine Model of Abdominal Wall Repair. Poster presented at: Plastic Surgery Research Council 2019; Baltimore, MD, USA.
  4. Mlodinow A, Yerneni K, Hasse M, Cruikshank, T, Kuzycz M, Ellis MF. Evaluation of a Novel Absorbable Mesh in a Porcine Model of Abdominal Wall Repair. Manuscript in Press. Plastic and Reconstructive Surgery – Global Open. Accepted February 2021
  5. American Society of Plastic Surgeons. 2019 Plastic Surgery Procedural Statistics. Available at: https://www.plasticsurgery.org/news/plastic-surgery-statistics/. Accessed February 16, 2021.
  6. Smith JM, Broyles JM, Guo Y, Tuffaha SH, Mathes D, Sacks JM. Human acellular dermis increases surgical site infection and overall complication profile when compared with submuscular breast reconstruction: An updated meta-analysis incorporating new products. J Plast Reconstr Aesthet Surg. 2018 Nov;71(11):1547-1556.
  7. Kim JYS, Davila AA, Persing S, Connor CM, Jovanovic B, Khan SA, Fine N, Rawlani V. A meta-analysis of human acellular dermis and submuscular tissue expander breast reconstruction. Plast Reconstr Surg. 2012 Jan;129(1):28-41.

 

Contacts

Kristof Barron

[email protected]

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