FDA Grants Approval To Evera Medical's FulFil Lip IDE Application

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 13 Aug 2008 - 4:00 PDT

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Evera Medical announced that the U.S. Food and Drug Administration has granted conditional approval of the Company's investigational device exemption (IDE) application for its FulFil Lip cosmetic augmentation implant. This approval allows Evera Medical to assess the safety and effectiveness of the FulFil Lip implant in patients undergoing aesthetic lip enhancement. Enrollment into the study, named EIFFEL (Evera Implant -- FulFil -- For Enhancement of the Lip), is expected to begin within 30 days.

FulFil Lip consists of a very thin, stretchy balloon, which when filled with saline, is designed to replicate the supple, natural look and feel of youthful lips. The implant is filled with saline, which can be adjusted until the desired degree of enhancement is achieved. Once the implant is placed in the lip, a micro-valve prevents fluid from escaping. A thin coating allows gentle attachment to the lip tissue, without excessive scarring or firmness. The materials that make up FulFil Lip, used safely in medical devices for decades, are combined in a novel way intended to provide enduring softness.

"In formulating EIFFEL, we worked closely with the FDA, who reviewed our extensive bench and biocompatibility testing along with the long-term outcomes of our international lip augmentation study," said Dr. Michael D. Lesh, CEO of Evera Medical. "We are quite pleased with this approval and are optimistic that the trial endpoints will be met. FulFil Lip will be the first treatment of any kind to be specifically labeled for lip enhancement."

"I am excited to begin enrolling patients into the EIFFEL study," commented Dr. James Newman, Stanford facial plastic surgeon. Dr. Newman was also principal investigator in the lip augmentation trial conducted outside the United States. "Overall, the FulFil(TM) implant performed well in the international trial. Placing the implants is straightforward. Patients appreciated the fact that it could be performed in an outpatient setting using only local anesthesia. In the trial, 47 patients had lip enhancement with FulFil. In follow-up of more than a year, and up to 2 years in some cases, there were no serious device-related adverse events. On a scale of 0 to 7, patient satisfaction averaged 6.3, indicating a high degree of aesthetic benefit."

About Evera Medical

Founded in 2004, Evera Medical is located in Foster City, California. Evera's mission is to develop and commercialize soft-tissue implants for a variety of cosmetic and non-cosmetic applications, including facial rejuvenation and enhancement. Evera implants are designed to closely mimic the soft, compliant nature of human tissue, and to remain that way over time. The company's products employ a multilayer polymeric balloon that can be adjustably filled with saline. Evera implants use materials, combined in novel ways, whose clinical safety and biocompatibility has been long established.

The evolving EVERA line of facial implants is intended to fill folds, create plumper lips, and restore youthful curvature to the cheeks and chin. The goal is to provide office-based cosmetic enhancement that looks natural, feels soft, is customized to a given patient's desires, and is predictable and permanent, yet reversible.

Evera's products, which include FulFil Soft Tissue implant, for which CE Mark has been granted outside the United States, and VeraFil Augmentation Implant, which is FDA cleared for sale in the United States, incorporate its saline-filled dual-layer technology. These products are an alternative to the cost and inconvenience of treatments, such as injectable dermal fillers, which may need to be repeated to achieve enduring augmentation. Evera products have demonstrated excellent patient satisfaction and safety.

Evera Medical