An innovative new medical device, the ARTAS System™, Restoration Robotics Inc, Mountain View, Calif, is a physician-controlled system that enables the improved, speedier harvesting of hair follicles for transplantation.
The product combines an image-guided robotic arm and imaging features with a system that can identify and harvest individual follicular units to implement the follicular unit extraction (FUE) technique. Earlier this year, the ARTAS System was granted 510(k) clearance by the FDA.
James Harris, MD, director and founder of Hair Sciences Center of Colorado, in Denver, invented the device and recently spoke with PSP.
Harris says the device takes the guesswork out of FUE while allowing the physician to retain artistic control. "Nothing out there right now has the capabilities that this system has for hair restoration," he says. "There are other applications for robotics, but this is the first in its field."
The robotic device was developed to solve problems in the current way grafts are obtained from a patient's head. "It's an evolution from using strips or taking strips obtained from microscopes, [which] would individually dissect out the follicular units," Harris says. "That method works great and is still a reasonable method of producing grafts, but there are some issues with it."
One issue, he continues, is that it leaves a linear scar in the back of the scalp. In addition, there is often a fairly lengthy recovery process, including several nights of fairly severe pain, another week or two of some soreness, and then up to 2 to 3 months of some numbness and some sensations of some tightness of the scalp.
With the desire to quell some of these issues, some research and investigation was done. Various doctors were asking, "Is there a less invasive way to get these follicular units out of a scalp?" From that, FUE, or follicular unit extraction, came into being, and that is removing the follicular units one at a time from the scalp. However, this presented a new set of issues to be dealt with. Removal of each unit individually is extremely time-consuming.
"Also, as you looked at the hair emerging from the scalp, it would have different angles, different directions. You never knew, based on what you saw on the outside, what the actual follicle was doing beneath the surface. A whole experimental stage ensued where people were trying to devise methods to deal with that."
Harris developed a methodology and some instrumentation to get the follicles out without causing too much damage. The process requires some practice and some experience, he notes.
Harris refers to the ARTAS robot as an "evolutionary" device that takes the guesswork, labor, and learning curve away to allow the physician to focus on the art of transplanting. One can start using the unit after a half day's training and provides "great grafts, great speed, high accuracy, and the patient gets great results," Harris adds.
FUE treatments are practiced by around 5% of the practitioners who do hair transplantation. Yet, patient demand has been growing for that particular approach, according to Harris. Are patients ahead of the curve compared to physicians when it comes to being informed about FUE?
"I think you're onto something there," he says. "The patient has done a lot of research. There's a lot of buzz on the Internet about FUE. The barrier into entry for the physician that does, say, strip surgery—one or two surgeries a day—is that FUE can be very time-consuming. I don't think the doctors necessarily discount it as a valuable procedure. It's just that it may not fit into their model right off the bat. It's hard to integrate."
Harris was an investigator in the ARTAS System clinical trials and notes how use of his FUE procedure and device has grown from 10% of his surgeries 2½ years ago to 50% to 60% of his surgeries today. "Patients are hearing about it, they want it, and they're going to seek out the doctors that are doing it," he adds. "The great thing about the robot is that it works."
How do you convince physicians that do hair transplantation that this is truly a more efficient and effective system than their own two hands?
"The robot determines everything that the physician might be guessing," he says. The angles, the direction; what's the depth I need to go? The robot is taking care of that, but it leaves everything within the hand of the surgeon in determining the artwork, the aesthetic, all those parameters that the surgeon wants control over. It still allows the surgeon to do that. It doesn't take that away."
In addition, the system provides increased speed and accuracy that you otherwise wouldn't have, he notes. On the other hand, he says, physicians realize the need for integrating FUE in their own practices, but they're reluctant because of the time and energy it takes to integrate the technology.
Though the robot is instrumental in getting grafts from the patient, the overall hair transplantation process is very labor intensive. "It's not uncommon to walk into a doctor's office and see seven to eight assistants working, planting the grafts or processing the grafts, cutting them from a strip," Harris says. "There's a lot of fatigue that goes along with this."
In a future version of the product, Harris wants to get the robot the artificial intelligence needed to carry out a detailed surgical plan and place the grafts with precision. As for robotics in general in the medical field, Harris notes, "I can see where robotics technology will also be valuable in cases where we might start gene therapy, where we have to introduce modifiers into the skin or cell multiplication, or introduce cells at a certain level to the scalp."
Sarah Russel is a contributing writer for PSP. She can be reached at .
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