First and Only Filler Approved in the U.S. to Correct Age-Related Volume Loss in the Cheek Area
January 7, 2014 (Newswire) - The Z Center for Cosmetic Health today announced that they will be offering JUVEDERM VOLUMA (TM) XC, the first and only filler FDA approved to temporarily correct age-related volume loss in the cheek area in adults over the age of 21. JUVEDERM VOLUMA (TM) XC helps create a more youthful appearance to the face and provides natural-looking and long-lasting results up to two years with optimal treatment.
"We are very excited to be adding JUVEDERM VOLUMA (TM) XC to our current list of innovative non-surgical cosmetic treatments at the Z Center for Cosmetic Health," said owner and medical director Dr. Michael Zadeh, F.A.C.S. "JUVEDERM VOLUMA (TM) XC, is unique in that it is especially formulated to correct age-related volume loss in the cheek area. It is perfect for those patients whose needs were previously unmet by other fillers out on the market."
Allergan, which manufactures JUVEDERM VOLUMA (TM) XC, conducted a pivotal clinical trial in the United States and Canada for submission to the FDA. The trial was designed to assess the safety and effectiveness of JUVEDERM VOLUMA (TM) XC as a non-surgical option for patients desiring volume in the cheek area to correct age-related volume loss. The trial demonstrated that JUVEDERM VOLUMA (TM) XC was an effective treatment compared to the control group, which did not receive treatment.
"Loss of volume in the cheek area is a normal part of the aging process," states Dr. Zadeh. "The clinical trial conducted by Allergan proved that there were proven results with JUVEDERM VOLUMA (TM) XC treatment, with noticeable correction of age-related volume loss in the cheek area and a more youthful appearance to the face."
JUVEDERM VOLUMA (TM) XC is made with Allergan's proprietary VYCROSS(TM) technology, an advanced manufacturing process that results in a smooth gel that flows easily and consistently. This unique formulation contributes to the lift capacity to correct volume loss in the cheek area with results lasting up to two years. Additionally, JUVEDERM VOLUMA (TM) XC contains a small amount of lidocaine which helps to numb the treatment area during the injection procedure.
The JUVEDERM VOLUMA (TM) formulation without lidocaine was first introduced in Europe in 2005. JUVEDERM VOLUMA (TM) with lidocaine was first introduced outside the U.S. in 2009. As of August 31, 2013, JUVEDERM VOLUMA (TM) with lidocaine (branded as JUVEDERM VOLUMA (TM) XC in the U.S.) is distributed in 72 countries, including markets in Europe, Latin America, Middle East, Asia Pacific, and Canada. The JUVEDERM (R) family of products, including JUVEDERM (R) Ultra and Ultra Plus, are marketed and sold in 85 countries outside the United States.
"With the addition of JUVEDERM VOLUMA (TM) XC to our practice, along with BOTOX (R) and JUVEDERM ULTRA XC (R), I can successfully treat the face as a whole, giving a more precise and longer lasting correction of age-related volume loss of the entire face," said Dr. Zadeh.
The most common side effects observed in the clinical trial included temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. They were predominantly moderate (uncomfortable) in severity, with a duration of two to four weeks.
For more information about JUVEDERM VOLUMA (TM) XC and the Z Center for Cosmetic Health, please visit http://www.zcosmetichealth.com/juvederm-voluma-xc/.