FOSTER CITY, Calif., Oct. 29 /PRNewswire/ -- Evera Medical, a medical device company that commercializes small, saline-adjustable facial implants for a range of indications, today announced it has been two years since the first patient was treated. No serious adverse events have been reported.
"We are extremely pleased with the performance of our novel tissue augmentation products. The safety and effectiveness that has been demonstrated are very encouraging." said Dr. Michael D. Lesh, Chairman and CEO of Evera Medical.
Dr. James Newman, an internationally-regarded facial plastic surgeon from Stanford University in California and a pioneer in saline-filled augmentation, presented the Evera experience at the recent annual New York Aging Face Conference. "As of September 1, 670 devices have been implanted. We have not seen any serious complications. This is a remarkable record of safety for an implant intended for permanent augmentation," commented Dr. Newman. "The fact that the implant can be removed if the patient desires a different look is a real bonus. Patients are treated in the office during a simple procedure that typically takes around 15 minutes. Patient satisfaction is quite high."
Evera's products, which are marketed as FulFil(TM) Soft Tissue Implant internationally, and VeraFil(TM) Augmentation Implant domestically, consist of a very thin, stretchy balloon, which when filled with saline, are designed to replicate the supple, compliant look and feel of youthful tissue. During patient treatment, the product is filled with saline (our natural tissue fluid), which can be added or removed until the desired degree of enhancement is achieved. A micro-valve prevents fluid from escaping. The devices are coated with a highly biocompatible material using a proprietary method designed for limited tissue attachment. This unique feature allows the implant to maintain the soft, conformal characteristics imparted by the liquid fill. Evera's products are designed to provide permanent, predictable volume augmentation, yet to be completely reversible.
"More than 70 physicians have treated patients with our implants. Both physicians and patients have expressed a high degree of satisfaction. We expect adoption to continue to grow as a result of these favorable outcomes," remarked Dr. Lesh. The company is pursuing regulatory clearance for an expanded range of products.
Dr. Newman added that "some dermal fillers last only a few months. Others that might last longer are difficult or impossible to remove, even if there is a complication. The lips are especially vulnerable. That's the nice thing about the Evera implants. The look is permanent and predictable, but it can be reversed."
ABOUT EVERA MEDICAL
Evera Medical is based in Foster City, California. This medical device company's mission is to provide tissue augmentation implants for a variety of applications, including the lips and area around the eye. The company's products make use of its proprietary, saline-adjustable multilayer technology. That technology aims to create a natural-feeling and natural-looking treatment that is an alternative to the cost and inconvenience of the repeated therapy that might otherwise be required to achieve enduring augmentation.
Outside the United States, the company markets FulFil(TM), which was issued the CE Mark in April for augmentation of facial soft tissue, including lip augmentation, and VeraFil(TM), which was cleared by the US FDA for augmentation and reconstruction in and around the orbit of the eye. There were approximately two million dermal filler procedures in the U.S. in 2006, an increase of 25 percent over the prior year, according to the American Society for Aesthetic Plastic Surgery.
Further information about the company is available at http://www.everamedical.com or by calling 650-525-9750.
CONTACT: Dr. Michael Lesh of Evera Medical, +1-415-509-8315
Web site: http://everamedical.com//
