Aesthetic Sciences, Menlo Park, Calif, received the CE mark for its dermal filler delivery system — the Smartfil™ power-assisted injection system. The CE Mark provides clearance for sales throughout Europe certifying that a product has met European Union health, safety, and environmental requirements. The Smartfil system is the first powered device approved for use with dermal fillers and the first product in the new category of power-assisted injection systems.
“Based on use in a controlled clinical setting, doctors noted improved precision in the placement of fillers, less fatigue and overall improved quality of correction when using the Smartfil system. Additionally, patients noted less pain and bruising with this system as compared to manual injections,” said Stacy Smith, MD, of Therapeutics Inc, who conducted much of the clinical work for the Smartfil.
“The Smartfil system is the first product in a new category of power-assisted injection systems. We are interested in partnering with a major company in the field of dermatology who can optimize the launch of this novel device,” said Gary Petersmeyer, chairman and chief executive officer of Aesthetic Sciences.
Aesthetic Sciences is also pursing regulatory clearance in the United States.