About Ideal Implant Incorporated
Q: What is Ideal Implant Incorporated?
Ideal Implant Incorporated is a company that was established to develop, manufacture and market a new breast implant with the first new technology in more than 20 years. Plastic surgeons provided most of the funding for the company, helped with the implant design and are the majority owners. Ideal Implant Incorporated is unique - it is the plastic surgeons’ breast implant company.
Q: What is the IDEAL IMPLANT?
The IDEAL IMPLANT is a patent-protected, investigational, saline-filled breast implant that uses no new materials, fillers or manufacturing processes. It is made from only standard saline implant shells, valves and patches, with only saline as the filler. Its unique design has a series of implant shells of increasing size nested together to give it internal structure and to control movement of the saline. It is designed to contour to the chest wall and feel similar to a silicone gel implant.
Q: Is the IDEAL IMPLANT approved for commercial use?
No, not at this time. However, the Company filed an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA). Pre-clinical testing of the implant was conducted to demonstrate that it meets FDA standards for breast implants. With IDE approval by the FDA, the Company will conduct the IDEAL IMPLANT clinical study at up to 30 sites nationwide. At that time, it will only be available for investigational use.
Q: How was the IDEAL IMPLANT developed?
The Company has worked diligently over several years to refine the design of the IDEAL IMPLANT.Input from many plastic surgeons who are investors and/or who participated in market research interviews guided this process to obtain the best possible design.
Q: What is the FDA approval process for the IDEAL IMPLANT?
Breast implants are considered to be Class III devices by the US Food & Drug Administration (FDA). Class III devices are the most extensively regulated and require a pre-market approval application (PMA) before commercial sales can begin. Even though the FDA has approved standard saline-filled breast implants, this new saline-filled implant must still go through the complete regulatory approval process, including pre-clinical testing, an application for an investigational device exemption (IDE) to permit clinical testing, a two-year U.S. clinical trial with a plan for ten-year follow-up, and a PMA submission.
Q: What are Ideal Implant Incorporated’s plans for manufacturing the IDEAL IMPLANT?
The Company is working with recognized U.S. leaders in silicone medical device manufacturing to provide superior materials, workmanship and inspection so the finished implant meets the highest standards. The Company has chosen manufacturing facilities with ISO-13485 certified quality systems so women and their surgeons can have confidence in the IDEAL IMPLANT.
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