Surgical Innovation Associates (SIA), a start-up medical device company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for DuraSorbTM Monofilament Mesh, the first in a line of advanced bioabsorbable technologies for reconstructive and cosmetic surgery.
Each year, more than 1 million Americans are implanted with surgical mesh to provide the soft tissue support that is necessary in a variety of general and plastic surgical procedures. Much like an absorbable stitch, DuraSorbTM Monofilament Mesh is designed to integrate into the patient’s tissue – providing strong support during the critical initial phases of healing – and then slowly dissolve, leaving the patient free from foreign material within one year. The device brings cutting-edge polymer science and evidence-based engineering to bear on a material that has been safely used in other surgical applications for decades. DuraSorbTM will be released in select geographies in early 2019.
“The idea of a mesh that is there when you need it and gone when you don’t is appealing, for much the same reason that absorbable sutures have become a key part of a surgeon’s armamentarium – tissue support from a foreign material is crucial during healing, but at some point thereafter may become a liability,” says Dr. John Kim, inventor of the device and Professor of Plastic Surgery at Northwestern University. “This technology was developed in direct response to unmet clinical needs in our field.”
Complications following mesh placements can range from long-term pain to non-healing wounds. Historically there has been a dichotomy between permanent synthetic meshes and biologic meshes. Permanent synthetics provide favorable long-term support in hernia surgery and abdominal wall reconstruction. However, they are known to expose patients to long-term risk of pain, non-healing wounds and complications during later operations. Biologic meshes – derived from human or animal cadavers – promise long-term biocompatibility once they integrate into the patient’s tissue, but carry excessively high cost, risk of adverse inflammatory reactions and mixed clinical results.
“Having known people who have gone through the pain of multiple mesh-related operations, I found it gratifying to collaborate closely with opinion-leading surgeons to make DuraSorbTM a reality,” says Alexei Mlodinow, CEO of SIA. “Their guidance went into every key decision during product development, and will now steer our clinical trial strategy as we replicate our robust preclinical data in a real-world setting.”