mVASC® is a sterile, off-the-shelf human microvascular tissue allograft consisting of microvessel extracellular matrix intended to repair deficient microvascular tissue, improve blood flow, and support the healing of full-thickness wounds.
• Can be used wherever microvascular deficiencies exist (example: can be added to a nonhealing wound to restore blood flow and heal the wound)
• Increased complete wound closure at 12 weeks
• Increased percent wound area reduction from weeks 4 through 12
• Decreased time to healing
• Improved local neuropathy
• Increased perfusion and improved regional neuropathy
mVASC® is restricted to homologous use for supporting the repair of damaged microvascular tissues. It can be used wherever microvascular deficiencies exist. For example, mVASC® can be added to an ischemic wound to improve blood flow and healing.
The mVASC® manufacturing process involves exposure to gentamicin, and clindamycin. The safety of product use for patients with hypersensitivities to these antibiotics is unknown. The mVASC® manufacturing process involves exposure to collagenase and neutral proteases. The safety of product use for patients with hypersensitivities to these compounds is unknown. The mVASC® microvascular tissue treatment is not suitable for intravenous injection.
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.
No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of mVASC® microvascular tissue treatment.
Do not resterilize.
Do not use if expiration date has been exceeded or if there is evidence of defects in the package or label integrity.
Restricted to use by a licensed clinician.
The physician is responsible for determining the appropriate amount and use of mVASC® microvascular tissue for each application.
Health care practitioners are responsible for maintaining recipient records for the purpose of tracing tissue post-implantation. Patient tracking labels are provided for this purpose.
Normal rehydration of mVASC® microvascular tissue is usually accomplished in 2 minutes.
Do not centrifuge.
Do not use if the package seal is broken.
Unused or expired product should be discarded in accordance with local, state, and institutional human issue disposal requirements.
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® microvascular tissue or the implant procedure include:
- Wound dehiscence
- Disease transmission
- Hypersensitive, allergic, or other immune response
mVASC® is stable for 5 years when stored at room temperature. Store in a cool, dry place and in a manner that protects the integrity of the package and sterile barrier
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
mVASC® can be applied topically, or rehydrated with sterile water and implanted.
mVASC® should be applied weekly, and remain undisturbed between applications.
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