FDA Clears 2 Wound Dressings from 3M Health

FDA has cleared two 510(k)s from 3M Health Care for its 3M Veraflo Cleanse Choice Complete Dressing and 3M VAC Veraflo Cleanse Choice Dressing, which the company describes as negative pressure wound therapies. 3M says the dressings received the first-ever clearance for hydromechanical removal of infectious materials, non-viable tissue and wound debris, which reduces the number of surgical debridements required. The devices also promote “granulation tissue formation, creating an environment that promotes wound healing,” it says.

3M says the clearances were based on data showing that Veraflo Therapy had significant clinical advantages and economic savings versus other advanced wound therapies, including traditional negative pressure wound therapies, such as:

• Wounds ready for closure almost twice as fast (7.88 days vs 14.36 days)
• Wounds were 2.39 times more likely to close
• More than a 40% reduction in the number of required surgical procedures