Guard Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for additional large sizes of its NPseal Negative Pressure Wound Therapy (NPWT) surgical dressing.
The newly approved sizes now accommodate surgical wounds of sizes up to 25 cm.
NPseal is a surgical dressing that delivers negative pressure therapy to promote wound healing. It is designed for treating closed surgical incisions and features an integrated pump that creates and maintains negative pressure with just a few pinches.
According to Guard Medical, the advanced NPWT dressing is user-friendly, affordable, and cost-effective.
In addition, NPseal enhances patients’ lives by allowing them to recover at home without using tubes, bags, batteries, or drains, making healing simple so patients can return to their normal lives.
In February 2022, the medical device company announced the completion of the post-market study of its NPseal at Keck Medical Center of USC.
Guard Medical CEO Machiel van der Leest said: “We’re excited to expand our portfolio with the NPseal 20 and NPseal 25.
“FDA clearance for the additional large sizes allows NPseal to become the dressing of choice for the treatment of closed surgical incisions in orthopaedic, caesarean, and cardiothoracic procedures.
“We believe that NPseal uniquely fits in the ever-increasing outpatient trend requiring higher patient mobility and self-care.”
The medical device firm said that NPWT has been demonstrated to reduce surgical site complications (SSCs) in various peer-reviewed studies.
Conventional disposable NPWT devices have seen limited adoption due to their high cost and complexity.
NPseal dressings address these issues by making NPWT more accessible and practical, expanding its application, and encouraging a shift from advanced wound dressings and standard dressings.
Guard Medical’s NPWT technology was developed in collaboration with New York-Presbyterian and Weill Cornell Medicine.
The company is currently supported by investors such as Bpifrance and Matignon Investissement et Gestion.
Guard Medical aims to create NPWT solutions that cater to a diverse array of surgical wound types and sizes and advance infection prevention, scar reduction, and overall cosmetic outcomes.
