Hair transplant robot gets FDA approval, men with straight brown hair rejoice

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Hair transplant robot gets FDA approval, men with straight brown hair rejoice

ARTAS SYSTEM RECEIVES FDA CLEARANCE FOR GROUND-BREAKING TECHNOLOGY TREATING HAIR LOSS

Restoration Robotics, Inc., a medical device company that pioneered the first robotic follicular unit harvesting system, today announced that it has received FDA 510K clearance for its revolutionary ARTAS System

Mountain View, CA €“ April 14, 2011 €“ Restoration Robotics, Inc. a privately-held medical device company, today announced that its revolutionary technology, the ARTAS „¢ System, has received 510K clearance from the Food & Drug Administration (FDA) for harvesting hair follicles from the scalp in men diagnosed with androgenetic alopecia (male pattern hair loss) with black or brown straight hair. The ARTAS „¢ System was developed in close collaboration with several leading hair restoration physicians to enhance the quality of follicular unit harvesting for the benefit of physicians and their patients.

"We are thrilled to receive FDA clearance, and look forward to rolling out the ARTAS „¢ System to leading hair restoration physicians," said Jim McCollum, Chief Executive Officer, Restoration Robotics. "Hair loss is a very real issue for millions of men in the United States. We're pleased to offer a powerful new technology for patients who are interested in a safe new way to enhance their quality of life."

ARTAS „¢ is a physician-controlled, state-of-the-art, interactive, computer-assisted system that enables harvesting of hair follicles during hair restoration procedures. It combines several features including an image-guided robotic arm, special imaging technologies, small dermal punches, and a computer interface. The ARTAS „¢ System is capable of identifying and harvesting individual follicular units to implement the follicular unit extraction (FUE) technique.

The Benefits

"Many patients are seeking less invasive alternatives to the current hair restoration techniques," said Miguel Canales, MD, Medical Director, Restoration Robotics. "There is growing interest in FUE because of its many patient benefits, such as less discomfort and a quicker return to normal activities. The ARTAS „¢ System solves many of the technical challenges experienced by physicians currently attempting the FUE procedure which gives physicians and patients an exciting new choice."

Hair restoration is performed as an office-based procedure. Implanted hairs develop their own blood supply, begin to grow and new hairs are seen a few months after the procedure. New hair continues to grow over the course of a full year, making the change in the patient's appearance gradually noticeable to others.

"I believe the ARTAS „¢ system will make hair restoration more attractive to a broader group of patients," said James Harris, MD, of the Hair Sciences Center in Denver, CO. "In my practice, I have seen a significant increase in patients asking for FUE because of its minimally invasive approach. They really liked the rapid healing and lack of a linear scar, which makes this procedure different from the strip method."

Hair Loss By The Numbers

According to the International Society of Hair Restoration Surgery (ISHRS)[1], at least 35 million men in the United States are affected by male pattern baldness or androgenetic alopecia. By age 50, approximately 50% of men will experience some degree of appreciable hair loss. Approximately one in four men suffer from male pattern baldness (MPB), which has psychological, professional and social consequences for these patients, such as:

· 68% of men feel helpless about their hair loss

· 73% of balding men feel they are less attractive than they were when they had hair[2]

· 77% of balding men would feel very or somewhat concerned if they were in their 20s, just starting their career and experiencing hair loss[3]

While prescription remedies, such as Propecia ® and Rogaine ®, offer some benefits to existing hair, hair restoration moves healthy, functioning follicles to the areas of the patient's scalp most impacted by baldness for more dramatic results. Hair restoration is a popular cosmetic procedure, with an estimated number of procedures exceeding 100,000 in the U.S. in 2009. Hair restoration is the only permanent solution for hair loss and can result in a natural, undetectable outcome.

 

[drewbie]

Interesting idea. I'm sure this'll be great until it malfunctions and tries to extract grafts from someone's EYES.
:T:

Still, would anyone here trust a robot (albeit mostly human-controlled) over a reputable surgeon and a group of technicians?

 

[Sparky]

Wouldn't be interested in being one of the first people to try this.

Any new pics More?

 

[Prohairclinic]

Very interesting, I sure am going to try to see this in action.
But what about all the patients with waivy or curly hair, blond, grey ...

 

[topccat29]

What €™s interesting is that all the innovation in hair transplantation seems to be the area of fue. Regardless of if it €™s a Neograft, drill or a robot it €™s all marketed to those who would like to offer the procedure but can €™t seem to master the technique.

I agree I certainly would not want to be the first one in the chair when they power up that robot.

 

[bullitnut]

No me either it would be scary as hell imo ....it would be kinda like letting some robot clip your pubic hairs with some rusty old garden shears imo)(_:: definately a no go risky situation for me.

 

[topccat29]

it would be kinda like letting some robot clip your pubic hairs with some rusty old garden shears

LOL, not a whole lot of room for error.

 

[Sofarsogood]

My father had a very serious "robotic surgery" in Los Angeles and it went amazingly well. Cancer related.

One young surgeon using two joysticks, one older specialist "supervising".
Straight out of science fiction.

http://en.wikipedia.org/wiki/Robotic_surgery

Time will tell if this robot is for real.

 

[CliffJohnson]

@Pretty much everyone in this thread:

Of course I would be willing to trust this procedure. These are machines with thousands of times the visual and coordination power of human eyes/hands. Of course it has to be engineered and tested many times but honestly.. we're in an age where sensors can image at the micrometer scale. In addition to groundbreaking sensors, mechanic systems are able to aim lasers at the micrometer scale for eye surgery. Picking up a follicle that is 60-100 micrometers with perfect precision is a cakewalk.

I would instead ask are you really going to trust a human whose performance varies day to day and is subject to fatigue, moods, and simple mistakes, and can't really see much more than a few pixels smaller than the period in the previous sentence? And over a machine that is amazingly more precise, can see the hair under the skin in 3D, and has a perfect track record for hundreds of thousands of transplants, being monitored by a medical professional?

 

[Prohairclinic]

As I said before, I am open for new developments.
However as is with all claims : show us the full grown patients results.

In that regard there should be no difference in robots or humans.

 

[topccat29]

It will be interesting to see what happens with the ARTAS system. Personally I don €™t think a mechanized device can even come close to the sensitive touch and feel of the fingertips. Anyone that has worked long enough with hand tools regardless of the trade knows exactly what this means.

It is also very interesting to hear what some of the strip only clinics are saying hoping it €™s their ticket into being able to offer FUE. One really does have to wonder how many patients whom are being sold strip by these same clinics would be better suited having FUE. I suppose the forums that are also threatened by FUE will also change their tune.

With more than $60M already spent on the ARTAS system I would imagine the investors expect a substantial return on their money and what will be most interesting is how ruthless the marketing will be to get that money plus some back in their pockets. Unfortunately this is not meant to benefit the hair transplant patient and that is reality but most will be unaware.

My guess is that they will use the tech angle as being revolutionary which will sell very well especially with the younger guys while proven methods will be labeled as archaic and no longer relevant again appealing to the younger crowd with little experience. These people want their money and it €™s going to result in disastrous consequences for many patients.

BTW where are all those fantastic results with the Neograft for that matter where are all the results from all the other crap that is hyped. The hype this time around will dwarf what the Neograft put out. I will be watching in anticipation.

 

[pvtpoint2010]

When I went to see Dr Bernstein about my Acell plucking results he said he was getting the robot in November.........He also asked me about doing a small 500-600 graft session using it...(For a fee)

Though the FUE road still sounds good to me I feel the robot needs to be tested FIRST .......The intro I read about it said it used several different cutting tools all around 1 mm and even a little bigger in some cases...

I would like to see not just the transplant results but the donor as well..........scaring may be the big issue IMO.......

BTW .......if any one is interested i think after the Acell failure that I may go back to Dr Cole for 2 small hairline sessions of 500-700 each......

Hopefully with PRP and Acell it will diminish any new white dot scars.....

 

[topccat29]

Being a tester on the robot would be a big mistake in my opinion. If what you say about the punch sizes are true I would suggest staying far, far away.

I wish I had something good to say about it but I can only state what I believe. With the amount of money invested in the development of this machine the price tag is going to be pretty hefty. The clinics that purchase this machine will be slaves to it due to the cost. Expect to see a giant spike in ill advised surgeries especially for young men that don €™t know any better.

The other issue I have is that I would like to know if these strip only clinics have been advising patients that would be better suited for FUE only or a combination of Strip and FUE that they would be better served going to clinics that perform FUE only or a FUE/Strip. If this is not the case then those same clinics are not doing what is best for the patient and are only doing what is best for them by offering strip only. Completely unethical in my opinion and having a robot does not give someone ethics.

Many are not going to agree with this and that €™s okay.

 

[topccat29]

The last round of financing which raised $41M for commercialization and marketing alone is very scary in my opinion. If my understanding is correct and the punch size is 1.65 mm than I would like to ask the clinics that offer it how they feel scarring will not be a problem. All one can do is sit back and watch. The average person will not know about punch sizes and will be completely clueless and nobody will even care as long as the money is rolling in.

 

[topccat29]

I €™m all for technology and advancements but I €™m also for providing the patient with as much information as possible and letting them make an educated decision. I hope everyone associated with this business regardless of their capacity becomes a billionaire but that do it honestly.

Let the patients that sign up for this robot know that the punch is bigger than what most highly skilled doctors are using and are getting a comparable or lower transaction rate. The result of using a bigger punch obviously is a greater chance for white dot scarring. Some of the pictures I have seen of clinics using a 1mm punch can only be described as shot gun blast to the back of the head.

This machine in its current state also limits the harvesting area so what exactly is the limit on how many fue €™s can be extracted over time. My guess is that it would be a fairly low number so what is the point? As I stated in my previous post the odds of over harvesting is going to be very high.

I would like to know the thoughts of all the consumer advocates out there. Why is important information always conveniently left out by many clinics and people in this industry?

I understand that we don't want to step on anyone's toes but you are either a consumer advocate or you're not. There is no in between.

 

[topccat29]

I have read on some websites that the ID is 1 mm so obviously this does make the OD larger.

I have also read that it is a double punch technique with the first punch having an OD of 1.65 along with the second blunt edged punch being 1.2mm

Regardless in my opinion the punch is much too large. Punch sizes were being debated back in 2004 and it was well known back then that a smaller punch .75mm - .85mm was the way to go. Too many patients were experiencing shot gun blast scarring with the 1mm punch and they were not very happy about it.

The point of the post is not to be negative about the technology. It is to point out something that I learned only through experience. Too many clinics will conveniently leave out important information if it doesn €™t benefit them. Like letting the patient know that there are clinics out there that do have the capability and skill to use much smaller punches which would limit scarring drastically. Of course this would benefit the patient but not the clinic that uses the larger punches.

I €™m posting it for the benefit of others because nobody told me sh*t during my 25 year journey. They only told me what they wanted me to hear. At this point, in my opinion this robot technology is a step backwards but the power of marketing never ceases to amaze me so I will find that aspect interesting to watch.

In fact their was a caller into that hairloss internet radio show that didn't seem to know much about the machine but couldn't wait to have a procedure using it. Seems like there will be plenty of young dumb guys out there ready to sign up with very little knowledge about the way things work, I know as I was one of them long ago.

 

[topccat29]

I grew up on the Southside of Chicago about 2 blocks from Midway airport. About 8 blocks in the other direction on the corner of 60th and Pulaski there was a small candy shop that one of my friends took me to as we were riding our bikes back in 1974 Dove Candies. I never knew it was there until that day and what I had was something I will never forget. It was the most incredible ice cream bar I have ever tasted in my life. It was made in small batches and hand dipped in dark chocolate. It was so incredible that the Mars candy bar company bought the rights to it from the owner Leo Stefanos in 1985.

I bought a box of those same Dove bars about 2 years ago. They are now mass produced with only profit in mind. The bar tasted like complete shit and I could taste the artificial ingredients and what mass producing has done to something that was handmade and of superior quality. This is what happens with mechanization and mass production you get shit if you have any doubts just take a trip to Wal-Mart. Who knows maybe they will start offering hair transplants too.

 

[Baldpatch]

How many doctors are using this robot?