Guard Medical announces FDA 510(k) clearance for next-generation NPWT surgical dressing

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Guard Medical, Miami, announced FDA 510(k) clearance for additional large sizes (surgical wounds up to 25cm) of its next generation Negative Pressure Wound Therapy (NPWT) dressing NPseal for the treatment of closed surgical incisions, such as in in orthopedic, cesarean, and cardiothoracic procedures. NPseal is an easy-to-use, affordable, and cost-effective NPWT surgical dressing with an integrated pump that establishes and maintains negative pressure with just a few pinches.

NPWT has been shown to reduce Surgical Site Complications (SSC) in a large number of peer reviewed articles. Conventional disposable NPWT devices have not achieved wide-spread use due to their high cost and complexity. NPseal dressings broaden NPWT’s application while driving conversion from the Advanced Wound Dressing and Standard Dressing markets.

Machiel van der Leest, CEO of Guard Medical said, “We believe that NPseal uniquely fits in the ever-increasing outpatient trend requiring higher patient mobility and self-care.”