This report originally appeared in the August 2010 issue of DOTmed Business News

If you were having a debate about the leading cola companies, you would only concentrate on Coke and Pepsi. If you were looking at the leading computer operating systems, then the rivalry would be between Apple and Microsoft. Surgical microscopes, share the same type of rivalry outline. There are two companies always mentioned in any discussion about the leaders in the industry- Leica Microsystems Inc. and Carl Zeiss Meditec, Inc.

Over the last couple of years, the surgical microscope has seen an enormous innovation push, moving from a classical optical system to one that relies heavily on digital technology.

"The key message is that we are moving from a glass and brass microscope to something that is really a software driven, digital visualization platform," says Dirk Brunner, vice president of sales and marketing for Zeiss. "Certainly, a part of it is very good optics, but it really goes beyond that."

Surgical microscopes are commonly used for neurosurgery, ophthalmology, ENT, plastic reconstructive surgery, urology, OB/GYN, and dentistry.

"A lot of exciting innovation is driving the industry right now," says Betsy Schwartz, director of marketing of the surgical division, North America of Leica Microsystems. "There are new neurosurgical applications including fluorescence technology, high-definition recording, integrated Apple applications, and new ophthalmic surgical microscopes."

Considering neurosurgery, which has always been a significant technology driver in the microscopic field, the buzz words this year are fluorescence, illumination, navigation, and integration.

Fluorescence technology

Neurosurgery involves some of the most difficult and complex procedures in medicine. Therefore, one of the most important and innovative features to become available in microscopic technology concerns vascular fluorescence, which is particularly important in neurosurgery to develop increasingly safe, gentle and efficient techniques, which do not impair any vital functions in the brain.

Leica Microsystems has developed an alternative to traditional fluoroscopy integrated with its neurosurgical microscopes. This technology involves the use of a drug in conjunction with a microscope filter that illuminates blood flow to confirm blockage in aneurysms during neurosurgery and to ensure there is blood flow in reconstructive surgery. This is important because now, instead of wheeling a fluoroscope or radiological imaging device into the operating room, the microscope itself can do the job of checking to see if surgery is complete in much less time.

Schwartz explains that Leica Microsystems has 510(k) clearance to market the Leica FL800 for vascular fluorescence in neurosurgery, cardiovascular surgery and plastic surgery.




"When the Leica FL800 is used for neurosurgery, the patient is injected with a drug called ICG (a fluorescent dye), which travels through the circulatory system. The doctor can then view the blood flow in the brain in real time," she says. "This is important because when the neurosurgeon clips an aneurysm, he or she wants to make sure that it is completely clipped and that no blood is leaking out of that aneurysm. In the past, surgeons had to bring another piece of equipment into the operating room, which takes time and requires another staff member."

The Leica FL800 enables a doctor to look directly through the microscope eyepieces and confirm that the blood is no longer flowing into the aneurysm, but is still flowing in neighboring blood vessels.

"Also," Schwartz continues, "in any type of bypass surgery, the surgeon wants to confirm that there is blood flow through that part of the anatomy. With this fluorescence technology, the surgeon can look through the microscope in real-time and confirm there is blood flow."

Leica Microsystems also has a microscope system for tumor oncology fluorescence, which helps doctors operating on patients with brain tumors called glioblastomas.

"In the past, it was difficult for surgeons to resection tumor tissue from healthy brain tissue, and surgeons had to be very conservative in resection," Schwartz says. "Now, the patient drinks a drug, called 5-ALA approximately six hours before the procedure. Upon reaching the tumor the surgeon flips in a special filter, which causes the tumor cells to be show up in a pink glow. The doctor can identify the tumor cells and be more aggressive in tumor resection, which hopefully can extend a patient's life."

Zeiss has also been aggressive in bringing fluorescence technology to its microscopes, understanding that it can be a lifesaver in the operating room for doctors to see things that can't be viewed with the naked eye. To deliver that ability, Zeiss developed the Infrared 800.

"With the most critical work being done on the brain for aneurysms, it's very important to understand what's happening inside the vessel, even though you can't see there," Brunner says. "Up until now, you had to wait until after a patient's procedures were finished to check. That's critical for the brain, because if you have a brain with no oxygen for four minutes, it dies. This vascular fluorescence module allows you to see the blood flow in the vessel intraoperatively. It's been a tremendous breakthrough and very popular among vascular surgeons."

Dr. Robert Spetzler, one of the country's leading neurosurgeons, heading up Phoenix's Barrow Neurosurgical Associates. For him, Zeiss is the microscope of choice. Spetzler says one of his favorite features with the Zeiss microscopes is the addition of ICG angiography, which is now incorporated into Zeiss' OPMI Pentero scope.

"This allows exquisite visualization of flow in the blood vessels through the scope using laser induced excitation of the dye and recorded with a special video camera," Spetzler says. "This incredible addition to our armamentarium has decreased the use of regular intraoperative angiography by 85 percent. It is hard to overemphasize the importance of this addition since regular angiography is not only very time consuming, but also has an unassociated risk."

For fluorescence-based tumor resection, Zeiss has introduced the Blue 400, a second fluorescence technology that is an important indicator that delivers a suitable basis for deciding on the extent of tumor removal.

Although the module is available in the U.S., Brunner explains that there is an additional dye that shows fluorescence through the microscope in the tumor but not in the unaffected brain tissue. This allows more complete tumor resection while avoiding the normal brain tissue. The dye is currently approved in Europe but is just now being investigated in the U.S.

Illuminating advances

LED lighting is one of the newest innovations in surgical microscopes, and Leica Microsystems has already begun utilizing LED technology on some of its surgical microscopes.

"We have two new surgical clinic microscopes, Leica M320 F12 for ENT and the Leica M220 F12 for ophthalmology that feature LED lighting. What's important about LED lighting is that it's better for the environment, it's a cool light, and it has a very long lifespan. For the surgeon who purchases a microscope with LED illumination today, his or her grandchildren will be changing the bulbs," Schwartz says. "LED illumination is an area that is expected to grow in other market segments as well."

OPMI Lumera is Zeiss' advanced surgical microscope that uses a new form of illumination to dramatically improve red reflex and depth perception during cataract surgery.

"It provides the ability to see ocular structures in greater detail," Brunner says. "It has radically changed the way the ophthalmologist works. What this does is it gives you incredibly stable and strong red reflex and allows you to see in the capsule, depth, clarity and contrast that has been unprecedented and never been there before. It is changing the way people are doing cataract surgery."




Doctors report being able to see cellular layers within the retina and have gained better visibility of the external limiting membrane and, in some patients, the line between the inner and outer photo receptors is more clearly defined.

Making a choice

Just as the arguments go on about which is better between Coke or Pepsi, every doctor has his or her preference for a particular microscope brand.

Dr David Langer specializes in state-of-the art, conventional, and minimally invasive neurological, vascular and spinal surgery at North Shore University Hospital in New York. When he operates, he always chooses a Leica model.

"The new Leica OH5 has a much shorter head, so your hands are closer to the patient, which I think is an advantage, but basically I think the optics are better. I also like the fact that you can use the microscope without using the computer. So, if you use the computer for a video recorder or whatever, you can still use the microscope separately," Langer says. "With Zeiss, it's all essentially a big computer box that runs the microscope, so if the computer crashes or there's some problem with the software, it just doesn't work, which I think is a major disadvantage."

Spetzler has different thoughts about Zeiss.

"I have evaluated and used all surgical microscopes. The Pentero surgical microscope was built with a large input from surgeons such as myself and thus has all the various capabilities that we routinely require to carry out our surgical procedures," he says. "It is exquisitely balanced, allowing the surgeon to steer it with a mouth grip eliminating the need to stop operating in order to reposition the scope. It has a foot control with a joystick that allows angulation of the scope at the same time. It is ergonomically well designed and has excellent video capabilities and appropriate side or cross table optics for an assistant surgeon."

Integrating with media devices

In May, Leica introduced a new application that allows integration between its surgical microscopes and an Apple iPhone, iTouch, or iPad, Med X Mobile.

"The surgeon can now wirelessly download videos directly from a Leica surgical microscope onto his iPhone, iTouch, or iPad, which is a huge innovation. There was an enormous acceptance by the doctors," Schwartz says. "The surgeon can finish a surgical case and immediately download video to show to family members or other surgeons. It's a very exciting new technology."

Langer was one of the first to utilize the technology and believes it is a great advancement to be able to transfer still photos or short MP4s to show the patient or his or her family what was done in the operating room.

"The nice thing is, historically, you had to go through iTunes to move things and that just created problems, because you can't put iTunes under a microscope just yet," Langer says. "Leica solved the problem. When you just want to show a little clip of a case, it's a really valuable piece of software."

Schwartz says that surgeons also use Med X Mobile for its teaching capabilities, whether it's teaching residents about a procedure they have done or showing another surgeon a specific situation.




Looking ahead

There are other things coming down the pipeline as well.

Bill Tinker, owner of the Tascosa Group, a used equipment seller and refurbisher that specializes in microscopes, believes that although the main companies come up with plenty of bells and whistles, "microscopes really don't do much more than what they did 20 years ago."

Tinker has something in the works that he thinks will revolutionize the microscope industry later this year. Although he couldn't give full details about his new product, because he is still looking for dealers, he did offer some hints as to what he is so excited about.

"What this new product will do is, essentially, make microscopes obsolete for a lot of different surgeries. It's a little miniature 1.8 mm fiberscope with a miniature chip camera on the end, and the fiber will connect to handheld instruments," he says. "This would be good for a dentist. They can connect instruments they already use as it gives them magnification and they can use a surgical technique like endoscopy, where they work off of a monitor. It has better illumination, so they can see a lot better."

The prototypes are expected to be available in late fall and Tinker will soon be naming the company that will manufacture the device.

The two big surgical microscope companies will continue to provide new innovations in the years ahead, as both companies have R&D departments continually trying to discover the next leap in technology.

Brunner says Zeiss plans to continue investing heavily in fluorescence areas and also are heavily investing in networking and workflow in the O/R. The company will also continue to be strong in navigation.

"This is very important. You have image guiding systems, much like the GPS we have in cars, but you have a GPS for a patient, not with a generic map, but with one that is specific to that patient that's created with a scanner and linked to a microscope," Brunner explains. "So the surgeon, when looking at the patient, becomes a part of that in what's called a virtual pointer so you always see where your focus point is."

As for Leica Microsystems, the company will continue innovating with illumination and new applications designed to help surgeons provide better care to their patients.

"We are always developing new technologies that will benefit patient outcomes through the surgical microscope," Schwartz says. "Whether that means through better viewing, illumination, features or video, better patient care is the ultimate goal."

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DOTmed Registered O/R Microscopes Equipment Sales & Service Companies
Names in boldface are Premium Listings.

Domestic
David Rolla, Rolla Biotech, CA
Dirk Brunner, Carl Zeiss Meditec, Inc., CA
Bill Tinker, Tascosa Group,CA
DOTmed certified
Justin Ball, Prescott's, Inc., CO
Morris Dweck, BH World, Inc., FL
DOTmed certified
DM100
Facundo Bahamonde, FB Eye Equipments, Inc., FL
DOTmed certified
DM100
Carlos Vargas, inCAV Technologies, FL
DOTmed certified
John Pritchard II, Venture Medical ReQuip, Inc., FL
Hugh Bailey, HB Enterprises, LLC, FL
DOTmed certified
Ann Wyrosdick, Vashaw Scientific, Inc., GA
Betsy Schwartz, Leica Microsystems, IL
Tom Tottleben, TSC, Inc., IL
Danny Tipei, INEX Surgical Camera & Power Repair, Inc., IL
DOTmed certified
DM100
Bruce Watkins, Med Flight Auctions, IL
Joseph LaFrange, Harlow Scientific, MA
DOTmed certified
Garret Purrington, Medical Equipment Dynamics, Inc., MA
DM100
Jason Fisher, FHL Services, Inc., MN
DOTmed certified
DM100
Ray Phillips, Drand Medical, LLC, OK
Stephen Rousset, Medical Equipment Solutions, TX
DOTmed certified
DM100
Bo Benson, Associated Surplus Dealers, TX
Philip Mothena, Simple Solutions, Inc., VA
Robert Overmars, BPI Medical, Inc., WA
DOTmed certified
DM100
Ron de Ru, NorthWest Supply, Inc., WA
DOTmed certified
Kevin Grant, World Medical Equipment, WA

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