Lipogems, a leader in medical technologies for orthopedic physicians, announced the U.S. Food and Drug Administration (FDA) clearance of the company’s Microfragmented Adipose Tissue Transplant System for orthopedic and arthroscopic procedures.
Lipogems successfully uses a patient’s own body fat (known clinically as adipose tissue) to assist in the healing process and, in some cases, used in conjunction with traditional orthopaedic surgery.
The use of reparative technologies in orthopedics is rapidly expanding and medicine is forced to keep up with patient demands and the forces that are placed on their bodies. This is true for all types of patients from young athletes to professional athletes, from weekend warriors to the elderly.
According to a leading Orthopedics specialist, “Orthopaedic conditions are the number one cause of disability in patients in the United States and they take a toll on their physical and emotional health, and the ability to support their families. Patients are living longer and are more highly active. They are really trying to maintain their quality of life and function freely. dermatologist.
The Power of Fat
Many patients are looking for another option to major invasive surgery. Fat has many important cells and is easy to get from the patient’s body. Cells from a patient’s own body are the best cells a patient can use.
Lipogems may be a great option for patients who have tried physical therapy, nonsteroidal anti-inflammatory drugs, or steroid injections, and other treatments that have not provided enough relief.
If surgery is needed, Lipogems may be ideal to help provide cushion and support to facilitate the healing environment and optimize recovery.
Orthopedic physicians are always looking for convenient technologies that are compliant with current standards. The Lipogems system uses a minimally invasive procedure to harvest, concentrate, then transfer the patient’s own adipose tissue, typically from the patient’s belly or “love handles.”
The procedure can be performed in the office or surgical setting in under an hour. The Lipogems system uses only saline to rinse and remove contaminants, typically oil, blood and cell debris, from the harvested fat. Lipogems then resizes, or “microfragments”, the tissue to an optimum size while retaining the fat tissue’s natural and beneficial properties.
The “clean” Lipogems tissue provides cushion and support for the area. In accordance with homologous use, the tissue processed in the Lipogems system may be used to facilitate the natural healing process by supporting the repair, replacement or reconstruction of damaged or injured tissue.
If a patient suffers from multiple orthopedic conditions, additional fat can be removed (in the same procedure) and processed through the Lipogems technology to help address those additional conditions.
For procedures performed in the office, there is minimal recovery time and the patients can leave the facility right away and go home with minimal pain medication.
History of Fat
In November 2017, the FDA finalized its rules guiding the use of Human Cellular and Tissue Products. The Agency reaffirmed that the Lipogems system meets the new guidelines’ criteria for minimal manipulation of the tissue, and that it is intended for homologous use.
“Fat has been used for many years in support of the repair or replacement of damaged or injured tissue,” according to Dr. Arnold Caplan of Case Western Reserve University in Cleveland, Ohio.
“Fat has a high concentration of reparative cells and is a very powerful tissue. How the fat is processed makes a huge difference on the quality of the tissue and if it meets the new FDA guidelines.”
Dr. Diego Correa, Assistant Professor, Department of Orthopedics (Division of Sports Medicine) & Diabetes Research Institute- Cell Transplant Center at the University of Miami’s Miller School of Medicine is also impressed by the Lipogems technology. “Fat has a lot of important structural and reparative cells (including pericytes, adipocytes, and other cells) and they need to be kept together to meet the new guidelines by the FDA. Lipogems is unique because it keeps the cells and tissue intact, and thus functions much like the way it does naturally in the human body—and meets the new FDA guidelines for minimal manipulation.”
Accept No Substitutes
According to Carl Llewellyn, President of Lipogems, USA, “There are many stem cell treatment centers and clinics using technologies that are not FDA cleared or approved. Many of these clinics are selling stem cell treatments unproven for safety and efficacy, and these lack FDA review and oversight.”
“In fact, many of these clinics are using a process to create a ‘stromal vascular fraction’ of cells isolated from fat tissue, which the FDA considers to be more than minimally manipulated, and thus, requiring significant regulatory oversight as an experimental drug. Lipogems is offered by leading orthopedic physicians from around the world and encourages patients to seek care from board certified orthopedic physicians and to ensure the technology they are using is cleared or approved by the FDA.”
Lipogems at Veritas Backstage
Lipogems‘ vision is to bring responsible, effective medical technologies to physicians and patients—and to establish the Lipogems system as a mainstream solution. Lipogems strives to provide physicians and patients with adipose tissue solutions to help maintain or restore patient lifestyles and to improve quality of life and recovery times.
These solutions may offer another option to those who may not want, or who are not candidates for, major, invasive surgery.
The Lipogems system is the company’s first product to receive 510(k) clearance in the United States and is indicated for the harvest, concentration, and transfer of autologous adipose tissue. The system meets new FDA guidelines for minimal manipulation and is intended for homologous use. The company is based in Milan, Italy and Norcross, Georgia, USA. Lipogems is distributed in 27 countries around the world.