• Can be used for skin defects that extend through the dermis into and/or through the hypodermis. 

In a Level 1 RCT, Wagner 1&2 DFUs were treated with mVASC vs. collagen dressing in 100 subjects:
• mVASC demonstrated a 9x greater odds of healing
• Increased DFU complete wound closure at 12 weeks (mVASC 74% vs. Control 38%)
• Increased DFU percent wound area reduction from weeks 4 through 12
• Decreased DFU time to healing

mVASC^® is intended for the repair, reconstruction, replacement, or supplementation of damaged extracellular matrix (ECM) in skin defects that extend through the dermis into and/or through the hypodermis.

The mVASC^® manufacturing process involves exposure to gentamicin, and clindamycin. The safety of
product use for patients with hypersensitivities to these antibiotics is unknown.

Processing of the human tissue, laboratory testing and careful donor screening reduces the risks of donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, there is still a potential for the transmission of infectious diseases.
Do not use if expiration date has been exceeded or if there is evidence of defects in the package or label integrity.
Do not use if the package seal is broken.
Restricted to use by a licensed healthcare professional.

Donor screening methods are limited, therefore certain diseases may not be detected. The following
complications of tissue transplantation may occur:
• Transmission of known infectious agents including but not limited to viruses and fungi.
• Transmission or causation of diseases of unknown etiology and characteristics.
Adverse reactions associated with mVASC^® or the implant procedure include:
• Seroma
• Wound dehiscence
• Infection
• Disease transmission
• Hypersensitive, allergic, or other immune response

mVASC^® is stable for 5 years when stored at room temperature.