ARTAS System

The device was approved by the Food and Drug Administration (FDA) in 2011 for use in harvesting follicular units from brown-haired and black-haired men. The ARTAS System is designed to facilitate hair restoration using the follicular unit extraction (FUE) technique.

The ARTAS System was developed by Restoration Robotics, Inc., a privately held medical device company founded in 2002. ARTAS was introduced at the annual meeting of the International Society of Hair Restoration Surgeons (ISHRS) in 2008, and clinical trials were begun to develop and validate the system. A 510(k) clearance for safety and efficacy from the FDA was granted to Restoration Robotics in April 2011. In 2013, the ARTAS System won the Gold Edison Award in Medicine.

Restoration Robotics announced the shipment of its 100th ARTAS System on October 7, 2014.

The ARTAS System was commercially launched with Version 4x. The newest system available is Version 9x.

The ARTAS System utilizes the follicular unit extraction (FUE) technique. Hair in the donor area, an area of permanent hair in the posterior scalp, is trimmed to make the follicles easier to identify and extract. The scalp is numbed using local anesthesia. The patient is seated in a semi prone position, and a skin tensioner is placed on the scalp to improve precision of the dissection depths.

Multiple cameras capture video images of the patient's donor area. Through its image processing software algorithms, the ARTAS System identifies different properties of the follicular units such as exit angles, orientations and density. Using this information, the robotic arm maneuvers the small dermal punches to perform the follicular unit dissection. The cameras monitor the location of the hair follicles and recalculate hair position every 20 milliseconds. The physician and technician make adjustments to fine-tune the dissection as required. The follicular units are then manually transplanted into the patient's recipient area.

The procedure takes approximately five to seven hours to perform, and in the United States can cost between $5,000 and $15,000.

The ARTAS System allows physicians to complete the FUE procedure up to 50% faster than if performed manually, and it lets less experienced physicians use the machine to handle the graft extraction process. Patients receiving the ARTAS procedure can return to normal activities in one to two days, compared to weeks or months following strip harvesting procedures. However, ARTAS is only FDA cleared for patients with straight, dark hair, and is limited to follicle extraction from the back and sides of the head, although doctors may use the robot off label on different hair types. Patients with limited hair in the donor area are not suitable candidates. As the ARTAS system can only identify dark hair, for patients with light or gray hair, the donor area is dyed black prior to the procedure.

A 2014 peer reviewed journal article in Dermatologic Surgery measured follicular unit transection (follicle damage) in the extraction of grafts with the ARTAS robotic follicular unit extraction (R-FUE) procedure. The study concluded that robotic transection rates, using the ARTAS Robotic System, compared favorably with non-robotic (manual) FUE transection rates. Furthermore, the researchers found the average rate of transection over many ARTAS robotic procedures to be 6.6%. This rate was significantly lower than an average manual transection rate of 17.3% reported in 2008 in a peer reviewed journal.

Restoration Robotics, the makers of the ARTAS Robot, have a credentialing system for physician utilizing their robots. Centers are ranked in ascending order: Bronze, Gold, Silver, and Platinum status. The rankings are on the official physician locator.