When Olympus Corporation of the Americas sets out to develop endoscopy products
they keep one concept at the forefront: to lower costs and improve outcomes. “That’s our first and foremost focus for all of our development process,” says David Colvin, director of marketing and surgical energy at Olympus.
But this is not something unique for original equipment manufacturers. Any OEM that wants to compete in the current marketplace must have the same mindset. The challenge for health care providers today is figuring out how to financially succeed in an era of growing patient demand and shrinking reimbursement.
“The entire health care world is moving toward a quality and cost driven system and I think the system as a whole is no longer willing to pay for expensive technology that don’t have proven benefits,” says Dr. Andrew Ross of Virginia Mason Hospital and Seattle Medical Center.
Minimally invasive procedures have become the gold-standard for lowering costs and improving outcomes. Endoscopic devices are used in these procedures to make small incisions, allowing patients to leave hospitals sooner with fewer complications.
What’s up with reimbursement?
“The big words out today are value and quality and that brings in a combination of things together and it’s kind of a perfect storm,” says James Laskaris, senior analyst at MD Buyline.
Lowering costs and improving outcomes were always in the back of health care providers’ minds, but with the introduction of the Centers for Medicare and Medicaid Services’ value-based purchasing and payfor- performance incentives, it’s now a top concern.
CMS created the programs in order to reward providers for enhancing quality and efficiency or penalize them for hospital readmissions and not meeting the program goals.
In the past, CMS paid providers a fixed amount for each procedure, but now the payment varies based on different factors. For example, 20 years ago, a hospital that delivered a baby would itemize everything they did during the procedure and get a bill, but now the insurance company varies the price depending on whether there were complications or not, says MD Buyline’s Laskaris.
Laskaris adds that endoscopic procedures improve quality of care by causing a lower chance of infection, less blood loss and recovery pain, a quicker recovery due to less tissue damage and a shorter length of stay. The hospitals save a significant amount of money since patients are not hospitalized for weeks, but they are also reimbursed more for ensuring better quality.
Additionally, health care reform takes patient satisfaction into consideration when determining how much a hospital will be paid. Since private insurance companies follow Medicare’s lead, it is expected that they will start to take patient satisfaction into consideration as well.
CMS’s new initiative, called Partnership for Patients, focuses on helping hospitals understand ways to improve quality. If hospitals don’t make patient satisfaction a primary focus, they could risk losing profits. It’s initiatives like this that play to the strengths of the endoscopy sector.
Patients typically express higher satisfaction rates after undergoing minimally invasive endoscopic procedures since they get out of the hospital quicker and with fewer complications. “Who wants to be in a hospital a week, you’ve got to get back to work,” says Laskaris.
Since patients prefer these less invasive procedures, the endoscopy device market is expected to grow substantially. A MarketsandMarketsreport found that the global endoscopy equipment market was estimated at 28.2 billion dollars in 2013 and is expected to reach 37.9 billion dollars by 2018.
The growing market
MARVEL, image courtesy of
the Skull Base Institute
Dr. Hrayr Shaninian of the Skull Base Institute collaborated with NASA’s Jet Propulsion Laboratory to create the multi-angle rearviewing endoscopic tool, MARVEL. The 4 millimeter device allows surgeons to perceive depth and see around corners that they previously could not.
This technology is a significant breakthrough in the area of brain surgery. According to the Skull Base Institute’s website, 98 percent of all brain surgeries are done with traditional open craniotomy. Open surgery is much more costly and patients are typically hospitalized for weeks and often have to undergo rehabilitation afterward.
“We have been running this experiment now for twenty years, there is no question that minimally invasive surgery of any kind works and has improved outcomes,” says Shaninian. “This has been proven over and over and over in every field and in the brain it’s even more obvious.”
Shaninian has big plans for this device outside of brain surgery. “I think this a significant breakthrough in all kinds of surgery because MARVEL will transcend the field of skull base and brain surgery and it will be valid in any kind of surgery,” he says.
Shaninian estimates that it will take nine to 12 months to get FDA 510(k) approved.
Another endoscopy update has been brought to market by Olympus. The company recently released what they claim to be the world’s only HD and 3-D endoscope called the ENDOEYE FLEX 3D Videoscope.
A surgeon who performs laparoscopic surgery with a traditional endoscope loses depth and has to train their minds to operate two-dimensionally. But this 3-D endoscope restores the natural vision that they would see in an open procedure.
After the surgeon places the endoscope into the trocars, they put on 3-D glasses and the organ or tumor is displayed in 3-D on the two monitors on each side of the patient.
“What this does is, and we have data to prove this, is makes their movements more precise, it reduces the number of errors and it improves or speeds up the learning curve for learning how to do laparoscopic surgery,” says Olympus’ Colvin.
Another unique feature is that the tip articulates, so surgeons are able to view desired organs from the angle they want. “They have better sight lines and they can peer around anatomical structures, like a large uterus or a tumor, and they can look at that structure from many different angles in 3-D, this provides more precise grasping, more precise dissection,” says Colvin.
Stryker has also recently created an articulating HD device called IDEAL EYES HD Articulating Laparoscope. With these new devices surgeons are able to see structures from angles they previously couldn’t, making surgery much more efficient.
Getting more minimal
Virginia Mason Hospital and Seattle Medical Center’s Ross says that the two minimally invasive procedures of most interest right now are endoscopic submucosal dissection, ESD, and peroral endoscopic myotomy, POEM.
“This is probably the biggest trend, the idea that we can actually work in the submucosal to dissect off early cancers and also to treat other diseases like Achalasia where we can actually tunnel through the wall of the esophagus and cut muscle fibers and traditionally that’s been done surgically,” says Dr. Ross.
ESD removes large lesions in the GI tract. It was developed in Japan in the mid-1990s. Prior to ESD, polypectomy was commonly used to remove the lesions. ESD is a breakthrough because unlike polypectomy, it leads to shorter hospital stays and recovery times.
POEM was also developed in Japan, in 2008, a little more than a decade after ESD. For POEM, the patient is put under general anesthesia and the surgeon uses an endoscope to go down the esophagus toward the esophageal gastric junction. The lower esophageal sphincter is then cut, which allows patients with Achalasia to ingest food more easily.
“There is a lot of technology and a lot of energy being spent toward being able to take these lesions out less invasively,” says David Pierce, senior vice president and president of the endoscopy division at Boston Scientific.
Olympus has a series of electrosurgical knives that enable smooth and efficient cutting during ESD including DualKnife, Hook- Knife and ITKnife2. They also have a couple of supporting devices called Coagrasper and EndoLifter.
Even though both procedures have been around for a while in Japan, they are just starting to emerge in the U.S. “That’s the typical trend, is that a lot of these techniques are honed and pioneered mainly in Japan and sometimes in Europe and then they’re brought over here,” says Ross.
Another procedure revolutionizing minimally invasive surgery is minilaparoscopy. Historically, conventional laparoscopy instruments were about 10 millimeters in length and overtime they shrunk to 5 millimeters, but KARL STORZ Endoscopy-America Inc. managed to create miniature laparoscopic instruments that only require a 3 millimeter incision.
“Development of minilaparoscopy technologies is being driven, in part, by the patient’s desire for outcomes that are not only successful, but also offer improved cosmesis,” says Susan Jaffy Marx, director of marketing communications at KARL STORZ.
The set includes HOPKINS II laparoscopes, CLICKLINE scissors and dissecting and grasping forceps, ergonomic and light trocars, electrodes for coagulation, stable KOH needle holders and instruments for suction and irrigation.
Specialties once dominated by traditional laparoscopic techniques including gynecological, general, pediatric, urologic, bariatric, thoracic and colorectal surgery, are now adopting minilaparoscopy techniques, says Marx.
Last year, Dr. Ceana Nezhat, a gynecologic surgeon and program director at Northside Hospital in Atlanta, started using the instruments to treat patients with endometriosis. “My personal opinion is that this is a definite tremendous advancement in performing major surgeries through a small incision,” he says.
When he used to perform procedures involving mesh embedded in organs with conventional methods, he says the results were unacceptable. He would have to cut through the mesh and undo what had been done and redo it again. But since the minilaparoscopy instruments are so small in diameter, he can go through the mesh without the need to undo and redo prior procedures.
He thinks that it’s a step beyond traditional operative laparoscopy and roboticassisted laparoscopy in the advancement of minimally invasive surgery.
Even more innovation
Stents and catheters, which are inserted= using endoscopes, are also bringing down costs and improving outcomes.
When patients show up to a hospital with acute colonic obstruction, they can either undergo a colostomy or a stent can be inserted to decompress the colon and then they undergo a single surgery. Two decades ago, urgent surgery was the first choice for treatment, but it was associated with high mortality rates because the patients were usually in poor condition due to the disease, dehydration and other factors.
“The patient impact and the cost of that type of technology is dramatically improved with stent alternatives,” says Boston Scientific’s Pierce.
A Boston Scientific study conducted in late 2010 compared the hospital costs and clinical outcomes between patients undergoing colostomy and those undergoing stenting for the management of malignant colonic obstruction. It found the stent placement is less costly and involves fewer complications.
Boston Scientific manufactured a stent called the WallFlex Colonic Stent that assists with those procedures. The stent is used as a “bridge to surgery” by decompressing the colon before the actual surgery is performed.
Additionally, what Pierce calls the “poster child for this trend” is a catheter-based product that treats patients with severe asthma. Even though some patients with severe asthma have access to all of the medications on the market today, their asthma is not well-controlled. “They end up being hospitalized for several days with quite a big expense to the individual and quite a scary experience,” says Pierce.
Boston Scientific purchased the company, Asthmatix, a few years ago, and along with it came a catheter called Alair that uses bronchial thermoplasty technology to treat these patients. Over the course of three treatments, Alair applies radiofrequency energy to the lungs.
In September, Boston Scientific published five year data, which showed “excellent and sustainable” results for the patients who underwent the treatment. It is currently being used at 300 centers in the U.S.
Experts say that this trend is here to stay and that endoscopic devices will continue to provide cost effective and efficient treatment.
“I think the key is that what we’re trying to do here in the U.S., and really all over
the world, is increase access, says Pierce. “In order to increase access, we’ve got to be able to do it more efficiently and more cost effectively because there’s not an unlimited amount of dollars that can be spent on health care,” says Pierce.
When it comes to the endoscopy market he is “very bullish” given the current environment because he knows endoscopy is headed in the right direction.
“Regardless of what legislation is in place or what type of funding is in place, I think endoscopy will always survive and thrive because we’re doing exactly what everyone needs to do, which is to do it more cost effectively and efficiently and have the broadest possible access for patients,” he adds.
Click here to check out the DOTmed New Equipment Guide for endoscopy.
DOTmed Registered HCBN March 2014 Endoscopy/Arthroscopy Companies
Names in boldface are Premium Listings.
Moshe Alkalay, Hi Tech Int'l Group, FL
Mike Rizzi, IEC-Innovative Endoscopy Components, LLC., FL
Thomas Szymczak, Vortek Surgical, IN
Robert Harris, Imaging Associates Inc., NC
Adam Rudinger, Lex-Tech, Inc., NY
Dan Kongsted, Cervius Medical, Denmark
german strupeni, hospital, Argentina
Rick Meerkerk, Mediproma B.V., Netherlands