Guard Medical Announces FDA 510(k) Clearance for Additional Large Sizes of Its Novel NPseal® NPWT Surgical Dressing, Unlocking the Orthopedic Market
Privately-held company Guard Medical Inc. today announces 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. 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.
“Following the successful clinical results of NPseal with my hip replacement patients, the additional large sizes will expand the use of NPseal to all our patients including knee replacement patients,” stated Asit Shah, MD, PhD, Englewood Orthopedic Associates, Englewood, NJ. “I look forward to dressing my patients’ wounds for success with NPseal.”
“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 orthopedic, cesarean, and cardiothoracic procedures,” stated Machiel van der Leest, CEO of Guard Medical. “We believe that NPseal uniquely fits in the ever-increasing outpatient trend requiring higher patient mobility and self-care.”
NPWT has been shown to reduce Surgical Site Complications (SSC) in a large number of peer reviewed articles. Until now, however, conventional disposable NPWT devices have not achieved wide-spread use due to their high cost and complexity. NPseal dressings uniquely broaden NPWT’s application while driving conversion from the Advanced Wound Dressing and Standard Dressing markets.
Guard Medical Inc. (www.guard-medical.com), a privately-held company, is commercializing easy-to-use, affordable, and cost-effective solutions that enable prophylactic Negative Pressure Wound Therapy (NPWT) wound care of closed surgical incisions. Guard Medical’s simple NPWT technology originated with New York-Presbyterian and Weill Cornell Medicine in response to physicians’ identification of unmet needs related to Surgical Site Infections (SSI). Current investors include Bpifrance and Matignon Investissement et Gestion.
Guard Medical’s vision is to develop NPWT solutions for use on a wide range of surgical wound types and sizes with broad applications for infection prevention, scar mitigation, and enhanced cosmesis.
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