Lipogems System: Lipogems System is the Best-in-Class FDA 510(k)-Cleared Device that is indicated specifically for use in orthopaedic and arthroscopic surgery. The cleared indications include the delivery of the tissue processed using the device called Microfragmented Fat (MFAT) into the desired space for the intention of repair, reconstruction, replacement, and cushion of injured or damaged tissues to aid in the patient’s natural healing process.
Microfragmented Fat (MFAT) Benefits:
- Compliant with FDA Guidance
- Meets FDA guidelines for minimal manipulation of tissue
- Uses saline to wash the tissue (enzyme free)
- Preserves cell and tissue microarchitecture
- Keeps niche intact
- Processing removes cell debris, oil, and blood
- The procedure is minimally-invasive and can be performed in the clinical setting or in conjunction with surgery in less than an hour.
- The system only uses saline to wash rinse and resize the tissue for optimal injecting.
- If a patient is suffering from multiple orthopaedic issues, the system can process enough adipose tissue for injection into multiple sites in the same setting. There is minimal downtime and recovery from this procedure compared to major, invasive orthopaedic surgery.
- No schedule delay: Can be performed in the clinic or procedure room without delays of surgical scheduling
- No hospitalization required
- One-time procedure for majority of patients
- Economical: May inject multiple sites in the same procedure
- Minimal Risk of infection and complications:
- No reported major adverse events and low complication rate with over 50,000 procedures
- Minimal downtime: Not able to take time off work for surgery when businesses re-open
- Minimal pain medication: 1-3 days
- Multiple sites:
- Cost: Cost is $2500-5000. May be comparable if not less than the cost of total joint (In network: $4,000-$6,000, Out of network: $15,000-$22,000)