Cellmyx First in the Nation to Receive FDA Clearance for a Reusable Fat Collection and Grafting System
The Lipo-Loop® system optimizes the fat grafting procedure from tumescence to harvest processing and delivery.
CARLSBAD, Calif., April 24, 2017 /PRNewswire/ — Millennium Medical Technologies (MMT) DBA Cellmyx has become the first in the nation to receive FDA clearance for a reusable fat collection and transfer system used in plastic or reconstructive surgery and regenerative aesthetics. This FDA clearance includes components used with the company’s liposuction and body shaping technology as well. This same clearance granted approval for low weight, sterile, disposable lids with bag that can be used for collection and transfer as well.
The Cellmyx Collection Canisters, Lids, Luer Extension, and Bags are used in conjunction with hospital or surgery center vacuum and/or cleared pumps, tubing and cannulas for collection and transfer of aspirated fat. Using the system, untreated fat may be reinjected via a cleared injection apparatus. This same system can be used with Cellmyx’s AcquiCell™, its proprietary soft tissue harvesting device, along with Cellmyx’s Lipo-Loop®, a disposable tubing set, which provides a closed mechanical delivery system for harvesting and transferring fat.
“The Lipo-Loop® system, which was developed in collaboration with Dr. Steven Cohen, a highly regarded plastic surgeon in San Diego, California, optimizes the fat grafting procedure from tumescence, to harvest, to processing, and delivery,” said Greg Miles, CEO of Cellmyx. “It provides the surgeon with a simple, closed, sterile fat harvest and transfer system that is easy for them and their staff to use.”
These suction canisters are molded from medical-grade materials. They come in sizes of 250, 500, 1,000, 2,000 and 3,000 ml, are packaged non-sterile but are autoclavable. Each fat collection canister has a stainless-steel Luer fitting at its base to facilitate the transfer of untreated fat back into the patient using a cleared injection apparatus. The 1,500ml and 2,500 ml collection canisters are used in conjunction with single-packaged gamma radiated Sterile Lids and Liners, made of medical-grade materials too.
Cellmyx also provides a point of care, office-based, adipose-derived cell-processing solution that uses the products above. Its flexible system offers onsite ability to harvest highly viable adipose tissue and “save” viable stromal vascular fraction cells (SVF) to add back to the adipose planed for transfer. These SVF cells are made up primarily of stromal and vascular cells within adipose along with the patient’s endogenous stem cells.
Indications for use are for fat grafting to the breast, buttock or large volume contouring; natural breast augmentation; and breast reconstruction. The system also is used for capsular contracture, radiated breast or body tissue, deformities after injuries, orthopedic procedures and facial rejuvenation and reconstruction.
“The system reduces the complex, messy, open systems that use expensive processing canisters or filtration bags,” said Dr. Cohen. “We’re extremely excited about the FDA clearance to further our mission of delivering comprehensive solutions and support for harvesting, isolating and deploying autologous tissues and cells,” Miles added. “With MMT’s protocol, we can harvest and save highly viable adipose and the supporting regenerative cells in about 45 minutes.”
Millennium Medical Technologies DBA Cellmyx is a FDA registered manufacturer committed to providing comprehensive solutions and support for harvesting, isolation, and deployment of PHSA 361 compliant tissue and cells. They manufacture and distribute devices in liposuction and body shaping, adipose tissue collection, fat grafting, autologous cell isolation and processing, as well as provide device development and clinical support services.