FRANKFURT AM MAIN, Germany–(BUSINESS WIRE)– Merz Pharma heeft vandaag bekendgemaakt dat zijn huidopvulmiddel Radiesse Lidocaine, met 0,3 procent integrale lidocaïne, een CE-markering heeft gekregen en snel beschikbaar is voor artsen in Europa.
Radiesse Lidocaine zorgt voor een direct verstrakkend effect en stimuleert de natuurlijke aanmaak van collageen, waarmee het de blijvende resultaten levert die patiënten en artsen van Radiesse verwachten. De pijn is bovendien fiks minder, door de toevoeging van lidocaïne aan iedere injectie.
Merz Receives CE Mark for Radiesse® (+) Lidocaine
FRANKFURT AM MAIN, Germany–(BUSINESS WIRE)– Merz Pharma today announced that its dermal filler Radiesse Lidocaine, with integral 0.3% Lidocaine, has received the CE mark and will soon be available to physicians in Europe.
Radiesse Lidocaine provides an immediate lifting effect and stimulates the natural production of collagen, providing the lasting results that patients and physicians expect from Radiesse 1-2, as well as significant reduction in pain due to the addition of lidocaine within each syringe 3.
“For many years, Radiesse has been a cornerstone of Merz’s global aesthetics portfolio. We are excited to introduce Radiesse Lidocaine, a technology that delivers the trusted properties of Radiesse along with enhanced patient comfort,” stated Can Gumus, Vice President of Global Marketing Aesthetics for Merz Pharmaceuticals. “Merz’s research and development programs are strongly committed to meeting key unmet needs of physicians and patients around the world. The addition of Radiesse Lidocaine is an important step as we continue to build on the unique technology platform underlying Radiesse.”
Radiesse Lidocaine injectable implant is an opaque, dermal filler that contains a small quantity of local anesthetic (lidocaine). In Europe, Radiesse Lidocaine is indicated for plastic / reconstructive procedures, including deep dermal and subdermal soft tissue augmentation of the facial area and for restoration and correction of facial volume loss. The presence of lidocaine is intended to reduce patient pain and to enhance comfort during treatment.
“In my practice, treatment comfort is a concern for the majority of my patients, and Radiesse is the number one dermal filler that I use,” stated Dr. Jani van Loghem. “Now with Radiesse Lidocaine, I can fulfill the aesthetic desires of my patients with a safe, effective dermal filler that provides both immediate lift and the enhanced comfort that they are seeking.” A specialist in aesthetic medicine, Dr. Jani van Loghem is a medical biologist and a medical doctor by training. He works in his private practice in Amsterdam as managing director of Doctors Inc., providing the full spectrum of aesthetic treatments with a heavy focus on injectables.
As of April 2016, Merz has distributed more than six million syringes of Radiesse worldwide. Radiesse received the CE mark for aesthetic use in Europe in 2004, with U.S. FDA approval following in 2006. In that time, Radiesse has emerged as a leading non-invasive aesthetic treatment trusted by healthcare providers around the world.
In a clinical study 3, 101 patients received Radiesse on one side of the face and Radiesse Lidocaine on the other side of the face. Patients rated their pain on a scale of 0 to 10. On the scale, 0 was no pain and 10 was very severe pain. Immediately after injection, patients rated their pain about 6.7 on a scale of 0 to 10 for the side of the face injected with Radiesse compared to about 2.3 on the same scale for the side of the face treated with Radiesse Lidocaine. Sixty (60) minutes after treatment, patients rated their pain about 1.1 on a scale of 0 to 10 for the side of the face injected with Radiesse compared to about 0.3 on the same scale for the side of the face treated with Radiesse Lidocaine.
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1 Sundaram H, Voigts B, Beer K, Meland M. Comparison of the rheological properties of viscosity and elasticity in two cate-gories of soft tissue fillers: calcium hydroxylapatite and hyaluronic acid. Dermatol Surg. 2010;36 (suppl 3):1859-1865.
2 Berlin AL, Hussain M, Goldberg DJ. Calcium hydroxylapatite filler for facial rejuvenation: a histologic and immunohisto-chemical analysis. Dermatol Surg. 2008;34 (suppl 1):S64-S67.
3 Schachter Science Brief: Pain Control using the Injectable Dermal Filler Radiesse (+) for the correction of Nasolabial folds. Daniel Schachter, Vince Bertucci, Nowell Solish. POSTER PRESENTATION at 13th Anti-Aging Medicine World Congress (2015), Monaco, Monte Carlo.