FDA Greenlights Lipogems® for Second IDE to Explore Knee Osteoarthritis Treatment in Clinical Trials
Thursday, October 05, 2023
The U.S. Food and Drug Administration (FDA) has recently granted Lipogems an additional Investigational Device Exemption (IDE) study opportunity to investigate the potential application of MicroFat for addressing knee osteoarthritis (OA). This second IDE study aims to assess the safety and efficacy of MicroFat as a treatment for knee OA in comparison to a saline control. It is set to involve the participation of 15-20 well-regarded orthopedic institutions, both in academic and private practice settings.
Lipogems has an extensive track record, having been utilized in over 60,000 medical procedures worldwide. Furthermore, it has garnered support from more than 140 peer-reviewed publications. Since 2014, Lipogems has held FDA clearance for its use in a range of general applications across various medical specialties, including orthopedics and arthroscopy. During its pursuit of FDA clearance specifically for knee OA treatment, Lipogems encourages physicians to continue utilizing the product for the broader indications already approved by the FDA.
Upon successful completion of both IDE studies focused on knee OA and subsequent FDA approval, Lipogems will be well-positioned to provide educational resources directly to physicians. This effort will help reach millions of patients who have explored conservative treatment options but are not yet prepared for or eligible for total knee replacement surgery.