I like to highlight qualitative, disruptive change in my health IT articles. The REVEAL FGS binocular (Figure 1), which allows safer surgeries on brain tumors, meets that criterion on several levels. The binocular is easier to use than previous solutions to the problem and is radically adapted to surgeon’s workflows. And a quantitative change–as a dramatic reduction in price–also leads to qualitative change. The device will probably spread to other types of surgery.
Million-Dollar Solutions Restrict Acccess
The myriad difficulties of brain surgery include seeing the boundaries of a tumor precisely. You don’t want to destroy any brain cells you don’t have to. The best way to see the area you’re operating on clearly is to use fluorescence to reveal the tumor. (The particular tumor targeted by REVEAL currently is called glioma.)
What is fluorescence? We probably all remember fluorescent lamps. They’re much less common than they were forty or fifty years ago because their light was unpleasant, and for other reasons. In surgery, fluorescence involves the patient injesting a substance that emits light when it is struck by light of the right frequency. The substance is 5-ALA, also called aminolevulinic acid. Done right, a tumor jumps out like a lighthouse in the dark, and you can cut it away while sparing the surrounding healthy tissue.
Why would a tumor react differently to light than normal cells? John Walsh, corporate vice president of Designs For Vision, explains briefly: “The photoactivated imaging agent that is injected into the patient is uploaded by all cells, but healthy cells release it. Tumor cells have broken mitochondria, so they cannot release the imaging agent. Thus, the imaging agent there releases Protophorphryn IX as a byproduct, and that is the molecule that fluoresces.”
For decades, the medical field has benefitted from microscopes that can reveal tumors through fluorescence. But like many medical devices, these microscopes are astonishly expensive. According to Walsh, they start at half a million dollars and often cost more than twice as much.
An academic hospital in an affluent community can afford a fluorescent microscope, maybe two. In other areas, brain surgeons perform surgeries, but they use regular lamps that are really inadequate for revealing the extent of a tumor. Quality suffers.
The traditional microscopes had another drawback. At some point in the surgery, the surgeon usually has to view the tumor from a different angle. To do that, staff have to reposition the microscope, which could take half an hour. This prolongs the surgery, creating risks to the patient and fatigue for the staff. In other words, the microscope was an extra facet of the surgery that staff had to accommodate and worry about.
The Solution from Designs For Vision
The contrast between the old microscope and the headset from Designs For Vision could hardly be starker, The REVEAL FGS binocular from Designs For Vision costs only $7,500 to $8,500, a drop in price of at least 85%. Furthermore, because the surgeon is wearing the headset, they can view the tumor from any angle merely by shifting their head in a natural manner.
Walsh says that every surgeon who has tried the REVEAL FGS loves it and says they don’t want to go back to using a microscope. At the low price, any hospital can easily afford a headset for every surgeon. This means that patients everywhere can benefit from more accurate and safer surgeries.
One big fan is Dr. Theodore H. Schwartz, director of brain tumor surgory at Weill Cornell Medical College. He has been there more than 20 years and has operated on several thousand brain tumors. Schwartz told me that he had envisioned a head-borne light source–in fact, he “desperately wanted” one–and tried to interest several manufacturers, but never got anyone interested. He was approached by Designs For Vision and has been using REVEAL FGS for three years. A typical surgery lasts four hours, and saving half an hour makes a big difference. He also does a better job with the brighter light, although he said the improvement in outcomes can’t be quantified.
Why did this solution arise just now? Why didn’t anybody challenge the market for million-dollar devices before? Walsh says there was no major technological breakthrough, although Designs For Vision incorporated some sophisticated, patented technologies in the binocular. The idea for their product arose through a routine review of technology.
Designs For Vision was founded in 1961 and created a variety of headsets for doctors and dentists. Thus, they were experts on optics and lighting, but not the particular fluorescent technology that the microscopes use.
In 2018, Walsh and his staff happened to attend a lecture on the medical uses of fluorescense by Dr. Walter Stummer. They were fascinated by the technology and its potential, and decided to produce a cheap device that was useful in brain surgery. Dr. Stummer had developed early headsets that made use of the technology. When Designs for Vision approached him, he enthusiastically worked with them and tested prototypes.
The COVID-19 pandemic notwithstanding, the company developed the REVEAL FGS over the next two years, and got it approved for use. The headset was released in May 2021.
Some Technical Details
It’s interesting to understand a bit how the REVEAL FGS works. It directs light at two frequencies toward the surgical site: 450 nanometers (which looks blue to the human eye) and 405 nanometers (which looks violet).
The lower frequency, 405, excites the byproduct of the agent that fluoresces, producing a pinkish-red light at 635 nanometers, which comes back at the surgeon. The 450 frequency, which provides relatively little light, creates a backscatter that provides more contrast.
One final benefit of the headset is that the light seen by the surgeon is about ten times brighter than the light returned by the microscopes (Figure 2). Lights in the operating room should be dim, but it doesn’t have to be totally dark.
The microscopes’ old, expensive technology is very complex and introduces a lot of intermediate steps that weaken the light. The solution from Designs for Vision is more streamlined. In addition, the expertise they built up over decades offers tricks to intensify the light.
The actual clinical effects of using the new device are hard to measure, but neurosurgeons have been enthusiatically adopting it.
Part of a trend
Moore’s Law in computer chips produced miracles of minaturization in many areas of computing. Although Moore’s Law has reached its limit, advances in hardware are still allowing devices to shrink, with associated savings in cost and battery life. A typical computer used to fill a room; then it filled a cubicle; now it sits comfortably in your palm; and more and more computers are found in devices a centimeter wide.
Patient health benefits tremendously when they can measure vital signs using a device next to the skin and view statistics on a cell phone. Low-cost devices are being created for developing nations and remote regions, bringing them diagnostic capabilities that used to be restricted to major urban centers.
The REVEAL FGS is a stunning example of this movement. It brings an elite capability to the masses. And it should be an inspiration for companies to take on new markets, bringing unusual expertise as Designs For Vision has done.
