Surgical Innovation Associates: Receives FDA 510(k) Clearance to Market DuraSorb Monofilament Mesh

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

How To Control a Radio Frequency (RF) Process

The radio frequency welding and manufacturing process uses electromagnetic energy and pressure to fuse and permanently bond vinyl, thermoplastic, and coated materials to produce a specific product - all according to customer requirements. Using this RF sealing process, a distinct, one-piece perpetual bond is formulated that is both solid and resistant to ripping or tearing. But how is this process controlled, and with what specific tools? Read on.

September 7, 2018

Surgical Innovation Associates (SIA), today announced they received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for DuraSorb Monofilament Mesh, the first in a line of advanced bioabsorbable technologies for reconstructive and cosmetic surgery.

Surgical Innovation Associates note that each year, more than 1 million Americans are implanted with surgical mesh to provide the soft tissue support that is necessary for 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 an 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 Surgical Innovation Associates. “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.”



Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.