FDA 510(k) Clearance and Key Patent for ‘Tautona Tissue Injector’
Tool Aims to Simplify Adipose Tissue Transfer Procedures; TTI is Second Tool to Emerge from Innovative Silicon Valley Firm
TauTona Group, a medical device incubator and investor focused on the rapid development of innovative surgical products, today announced that the TauTona Tissue Injector (TTI), a single-use, hand-held adipose tissue transfer tool, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Fat grafting, in which a patient’s adipose tissue is moved from one area of the body to another, is a frequently used technique that is growing in popularity for both aesthetic and reconstructive procedures. Earlier this year, TauTona sold its Surgical Marker technology to Novadaq Technologies Inc.
“Today most fat grafting is done using a 100-year-old technology: the syringe – a device that can be clumsy for clinicians to use,” said Geoffrey Gurtner M.D., managing partner at TauTona and professor of plastic and reconstructive surgery at the Stanford School of Medicine.
“Syringes often clog and can lead to difficulty in tissue transfer procedures. The TauTona Tissue Injector is designed to help physicians simplify their fat grafting procedures, which may lead to reduced costs. We designed TTI with the aim of providing clinicians an easy-to-use, ergonomic tool to improve the efficiency of fat transfer procedures.”
The TTI is a battery powered, single-use tool that requires no capital investment. It is designed to deliver adipose tissue at an even, controlled rate – with the aim of reducing the tedium and complexity of performing injections – allowing the surgeon to focus on placement of the fat. The device manages the pressure and flow rates during injection and is able to efficiently deliver this non-homogenous material without clogging. The TTI is designed to accommodate the surgeon’s current procedure; working with off-the-shelf cannulas, syringes (reservoir), and current fat processing techniques.
“At TauTona we believe the absence of a specialized fat grafting tool has made it more difficult for surgeons to provide their patients with precise, repeatable results,” said Dr. Gurtner. “As a practicing surgeon, I know the importance of offering predictable and consistent fat grafting results, with a reduced procedure time. Our hope is that the TTI will allow physicians to improve the procedure’s efficiency and ergonomics by reducing the time to re-injection. We believe that an effective fat transfer tool could increase the number of physicians using the technique and increase the number of procedures performed.”
The company also announced that it has received a key U.S. Patent for TTI from the U.S. Patent and Trademark Office (USPTO) and that it has other patents pending for the tool.