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CLEVELAND – The Cleveland Clinic unveiled the 3rd edition of its wildly popular Top Ten list of medical innovations on the last day of its annual Medical Innovations Summit in November. The list of breakthrough devices and therapies was selected by a panel of Cleveland Clinic physicians and scientists.

The innovations touch on avian influenza, electronic medical records, and various minimally invasive surgeries to treat uterine fibroids, to repair heart valves, and to remove organs through the body's natural orifices.

As usual, the selection process for nominating technologies was quite rigorous. Four major criteria served as the basis for qualifying and selecting the Top 10 Medical Innovations. Nominated innovations were required to:

• Have significant potential for short-term clinical impact (either a major improvement in patient benefit or an improved function that enhances healthcare delivery).

• Have a high probability of success.

• Be on the market or close to being introduced.

• Have sufficient data available to support its nomination.

A total of 60 staff representing a cross-section from every major medical field at the Cleveland Clinic, as well as operational leaders, were interviewed. From this list, nearly 100 medical technologies were nominated for consideration.

The AlixPartners (New York) advisory firm helped pare that list down to about 30 technologies that were presented to two independent panels of Cleveland Clinic physicians. These two panels then debated and voted on their own Top Ten and then in a combined process came up with the final list.

Here are the Top Ten medical innovations for 2009, from last to first:

10. Private Sector National Health Information Exchange . A comprehensive system of electronic health records that link consumers, general practitioners, specialists, hospitals, pharmacies, nursing homes, and insurance companies is in the process of being established. Primarily a private-sector effort, this computerized system has the potential to replace paper-based medical files with digitized records of patients' complete medical history.

While presenter James Young, MD, chairman of the academic department of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University (Cleveland), acknowledged that electronic medical records have been a "tough sell" to older traditional more classic caregivers, he noted that "we are moving dramatically and very rapidly with the youth of our country into a totally electronic communication world."

9. Doppler-Guided Uterine Artery Occlusion . Fibroid tumors occur in upwards of 40% of women older than 35, triggering pelvic pain, pregnancy complications, and heavy bleeding. There is a new, non-invasive approach to treat fibroids called Doppler-guided uterine artery occlusion, or DUAO.

Presenter Eric Jelovsek, MD, assistant professor of surgery in the section of urogynecology and female pelvic reconstructive surgery, department of obstetrics and gynecology, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, said that this procedure can allow women to have these fibroids removed and still keep their uterus. "If a woman is suffering from these disorders but wants to potentially have another child or two, this would be one of the only alternatives that would potentially be available," he said.

8. Integration of Diffusion Tensor Imaging (Tractography) . Diffusion tensor imaging (DTI) is a new technology that allows neuroscientists to non-invasively probe the long-neglected half of the brain called white matter, with its densely packed collection of intertwining insulated projections of neurons that join all four of the brain's lobes, allowing them to communicate with each other.

"This really has revolutionized the way we approach brain surgery," said presenter Gene Barnett, MD, professor and director of the Brain, Tumor & Neuro-Oncology Center in the clinic's Neurological Institute. I can ... map out any patient's individual nerve fibers and determine beforehand whether they are a likely candidate for surgery and what type of surgery I would do."

7. LESS and NOTES applications . LESS (laparoendoscopic single-site surgery) takes laparoscopic surgery to an entirely new level by reducing the process to a small cut in the belly button. NOTES (natural orifice transluminal endoscopic surgery) bypasses normal laparoscopic incisions altogether. Instead, the surgeon gets to an appendix, prostate, kidney, or gallbladder through one of the body's natural cavities, such as the mouth, vagina, or colon.

Mihir Desai, MD, director of the Center for Endourology and Stone Disease, Glickman Urological and Kidney Institute said that LESS and NOTES both "offer the possibility of doing complex intra-abdominal and even thoracic reconstructions through a single or a no scar approach."

6. New Strategies for Creating Vaccines for Avian Flu . A newer vaccine approach that uses a mock version of the bird virus called a virus-like particle (VLP) may offer a better solution to protect people against infection from the deadly avian virus.

5. Percutaneous Mitral Valve Regurgitation Repair . Using a tiny barbed, wishbone-shaped device, the heart is fixed non-surgically from the inside out. A catheter is carefully guided through the femoral vein in the groin, up to the heart's mitral valves. The clip, in this case the MitraClip from Evalve (Menlo Park, California) on the tip of a catheter is then clamped on the center of the valve leaflets, which holds them together and quickly helps restore normal blood flow out through the leaflets.

Marc Penn, MD, PhD, a staff cardiologist at the clinic's Heart & Vascular Institute, said that this device will be "a significant game changer" for patients who aren't candidates for open heart surgery and could provide them with "symptomatic relief."

4. Multi-Spectral Imaging Systems . The imaging system is attached to a standard microscope, where researchers can stain up to four proteins using different colors and look at tissue samples with 10 to 30 different wavelengths, allowing for the accumulation of more information than is currently available. This helps researchers to better understand the complicated signaling pathways in cancer cells, and to develop more targeted therapies, which might allow physicians to better personalize treatment for individual patients.

"This technology is going to allow us to take personalized medicine to an entirely different level," said presenter Jennifer Hunt, MD, section head, surgical pathology in the clinic's department of anatomic pathology. "I would say it's not just a step, it's a leap," she added

3. Diaphragm Pacing System . Four electrodes are connected to the phrenic nerves on the diaphragm. Wires from the electrodes run to and from a control box about the size of two decks of playing cards worn outside the body. When the electrodes are stimulated by current, the diaphragm contracts and air is sucked into the lungs. When not stimulated, the diaphragm relaxes and air moves out of the lungs. "I think it's an important innovation in that it really offers a quality of life to patients who are otherwise ventilator-dependent," said Penn.

2. Warm Organ Perfusion Device . Once a heart becomes available for transplant, surgeons have just four hours before the organ begins to decay. This device, though, recreates conditions within the body to keep the heart pumping for up to 12 hours.

"This is potentially really going to change the way we do heart transplantation," said Tomislav Mihaljevic, MD, a staff surgeon at the clinic's Heart & Vascular Institute. He said it allows a surgeon to extend the distance from where you can accept a donor heart and also to inspect hearts that the doctor might otherwise not accept and put them to use. He said the device also has promise in other solid organ transplants with the kidney, liver and lung.

1. Use of Circulating Tumor Cell Technology . A blood test that measures circulating tumor cells – cancer cells that have broken away from an existing tumor and entered the bloodstream – has the ability to detect recurrent cancer sooner, while also predicting how well treatment is working and the patient's probable outcome. The test results will allow physicians to better monitor a patient's progress, adjusting treatment if necessary.

Election's impact on innovation

Gathering less than a week after the election of a new Democratic president and a Democratic majority in both the House and Senate, those attending the Medical Innovation Summit wondered what that will mean for the industry that many have staked their livelihoods to.

An expert panel took a shot at divining the political tea leaves and providing the meeting attendees a valuable primer on what to expect in this new era.

Panel chair Charlie Cook, publisher of the Washington-based Cook Political Report, likened trying to process all the new information coming out after an election to "drinking water out of a fire hose. There's just so much data coming at you that it's hard to digest."

Cook noted that the recent election is a very complex and nuanced one with great policy consequences. He also pointed out that whatever President elect Barack Obama's initial policy plans may have been when he first ran for office "it's obviously going to be very different as a result of the recession we're in than what we would have thought just a few months ago."

He said that no matter what, healthcare is still an important part of our economy and the fastest-growing component of our federal budget, so it will have to be addressed. "How do you do that in the midst of a recession? How do you do that with the tax code that we have today?"

Since they did not get a filibuster-proof majority, Cook said that the Democrats are going to have to "reach across the aisle" in order to pass any truly meaningful legislation and reach beyond their more liberal political base.

Glen Bolger, a partner at Public Opinion Strategies (Alexandria, Virginia), noted that while the economy took center stage in the last few months leading up to the election, healthcare still "fit into the larger motif of 'we want change in this country.'"

Bolger concurred with Cook's assessment that the Democrats definitely have an advantage, but they cannot "overreach" in setting their political agenda, not only because they don't quite have the political capital do so, but because Independent voters, who are largely responsible for their rise in power this year, won't stand for radicalism of any sort in Washington for very long. He noted that more than 70% of these Independent voters like their current healthcare plan, but 25% of them realize that not everyone has an ideal situation.

"The challenge that any new healthcare policy faces is 'Look, we have to do something, but don't change what I've got – change what's bad for other people.'"

Chris Jennings, president of Jennings Policy Strategies (Washington), and former senior healthcare advisor to President Bill Clinton at the Domestic Policy and National Economic councils, challenged the assumption that nothing significant will get done on healthcare in 2009 because of the tough economic issues that will be facing this country and lawmakers.

Jennings noted that a recent poll that asked people to rank their greatest economic concerns showed that healthcare ranked above gas prices and job loss. It is a vey big concern for people, especially since it continues to become more and more unaffordable. "You cannot continually have your health insurance premiums increase at three times the amount of your wages and say this is not a problem, and that is what is happening in this country."

Another important factor that may be fueling a greater since of urgency to have a healthcare debate sooner rather than later is that businesses in this country say they cannot compete here and abroad due to these soaring healthcare costs. "They have concluded that they can't [manage healthcare] independent of some collaboration with the federal government," that predominantly regulates and helps finance private coverage under certain rules."

Since the national economy is heavily weighed down by healthcare costs, the costs of standing by will also be unpalatable to Washington, Jennings said. "If we do nothing over the next 10 years, we will see our current $2 trillion deficit in healthcare increase to over $4 trillion."

He believes policymakers will be forced to modernize the healthcare system and make it more efficient, "with a very significant emphasis on quality and value."

As they are doing this, he said that they also will be working to provide healthcare insurance to all Americans. He said that there is no way that healthcare costs in this country will ever be reined in "if we continue to have almost 50 million people outside the system."

According to Jennings, the talk has been about a multi-tiered healthcare system in the future, and he believes that is what Obama supports, and not the single-payer system that so many people in this country fear will happen with the Democrats in power. He said the desire is for everyone to have a chance to get healthcare and for insurance companies to be competing on "price and quality rather than risk selection."

He argued that we will never have a single-payer system in the U.S. "This country will never have Canada or England [style healthcare systems], we will have something that is uniquely American."

He said that what we really need in this country is "appropriate utilization of healthcare," meaning that in some cases one would want higher co-payments to constrain some technology and in other instances one would want these payments to be lower to encourage broader utilization of more efficient and effective technologies and medicines.

Jennings cautioned attendees to not sit around and wait to see what happens. "Always be prepared. Whether you think it's going to be a broad reform or a small reform, there's going to be a change in healthcare. Costs actually demand that we respond and everyone in this room should be prepared for that."

Tim Ring, CEO of C.R. Bard (Murray Hill, New Jersey), used his time to do an interactive poll with the audience.

The first question he asked was whether fundamental healthcare reform would be a top priority for an Obama administration, to which an overwhelming majority responded in the affirmative.

While most respondents agreed it would be a priority, the next question, which asked whether or not any meaningful healthcare legislation would be passed during the 111th session of Congress, drew an overwhelming "nay."

Another query Ring made asked whether the FDA process would become more lengthy and complex in the future, with another overwhelmingly affirmative response.

He also asked whether the audience believed that FDA enforcement and compliance would increase in the near future, and when faced with another overwhelmingly affirmative response, said that from his experience running a device company and from meeting with other companies in the space at meetings that "it's fairly clear and almost across the board that it already has increased over the last three or four years."

Ring said that in today's healthcare market, a company needs to provide proof of the utility of its technology. "If you come out with a new technology, you have to somehow simultaneously demonstrate what the economic benefit is, and that can be a broad-brush approach."

Wyden calls for 'bold reform'

Adding to the picture of whether healthcare innovation will be a priority for the 111th Congress, Sen. Ron Wyden (D-Oregon) also was on the speakers' roster at the meeting.

Wyden may play a larger role in laying out what any new healthcare system will look like in the U.S., particularly if the so-called Healthy Americans Act (HHA; S. 334), which he co-sponsored, is enacted into law. HHA is one of the most talked-about new approaches to extend healthcare to all U.S. citizens.

This bipartisan bill is designed to revamp healthcare as Americans currently know it. The bill is designed to lower healthcare costs by improving benefits, assisting lower- and moderate-income families in paying for private insurance and providing new opportunities to people to save from competition among health plans. The bill also is designed to provide true portability of coverage and encourages preventative and needed care.

Prefacing his remarks, Wyden noted that during a previous panel that he had watched at the summit, an audience polling question about the likelihood of meaningful healthcare reform legislation being passed in the next year had yielded a 60% 'nay' response. "I understand the skepticism," Wyden said, but added that there are several reasons to be more optimistic.

He noted that the U.S. economy has three primary legs – healthcare, of course, being one of them. The other two are financial services and energy independence. "I do not think you can get the economy back on track unless you fix healthcare and certainly from the standpoint of the long term, you cannot get the economy back on track unless you fix healthcare."

So why should Americans be optimistic of impending healthcare reform?

First off, Wyden cited the HAA, which is being co-sponsored by 17 senators (nine Republicans, eight Democrats). In the past 60 years, he noted that there has never once been a major group of Democratic senators and Republican senators actually co-sponsoring legislation to get everybody covered."

The second reason is that the Congressional Budget Office (CBO) has scored the HAA as "budget neutral" two years after implementation, "and in the third year, we actually start bending the cost curve downward." He noted that the Lewin Group, "the gold standard for analyzing healthcare plans," reached the same conclusion as CBO.

The third reason for his optimism, Wyden said, is that after visiting with 80 senators he sees the makings of a "real ideological truce emerging in the U.S. Senate on healthcare."

He said that Democrats have been right on the idea that all Americans should be covered, because otherwise "the people who are uninsured shift their bills to the insured."

The Republicans have been right, he said, on the proposition that there should be a very wide berth for the private sector with any plan. "The private sector is absolutely essential in terms of encouraging innovation and encouraging private sector choices." Wyden said that HAA "melds together" both ideologies into a working whole.

He said the healthcare scenario will play out in a stepwise fashion, with the bellwether event being the passage of a comprehensive children's healthcare program, which he said has bipartisan support as well as the interest of President-elect Barack Obama. "That's the touchstone event. How is that going to be integrated into the larger issue of broader healthcare reform?"

The next question that will come up is whether to then look to see what incremental steps can be taken to improve healthcare or to as Wyden said he advocates and "be bold." He argued that the "bold approach actually saves money and really stands as a paradox to the incremental steps that aren't going to produce the same savings, certainly nowhere near as quickly."

While he noted that some might see this as a contrarian notion given the country's current budgetary woes, "bold reform, because you change the incentives that drive behavior, is actually going to produce far more significant financial savings than going at this in an incremental way." He added that there will be a "spirited debate," in the Senate and the House about which approach will be best for the country.

Wyden noted that with HAA, everyone is guaranteed a basic "floor" coverage of healthcare, with those wishing to spend more for extra bells and whistles being able to do so if they want to.

Another way to bring about broader reform in healthcare, he said, is changing the insurance model in this country.

Wyden charged that the current model is "inhumane." He said it is about "cherry-picking" healthier people and sending the sicker people to government programs "that are much more fragile than they are."

He said that the new insurance model, in which a larger majority of Americans will be required to participate, will be completely different than today's flawed one. "It is going to be a different private insurance model. The companies are going to compete on the basis of price benefit and equality rather than who is the best at scouring risk and unloading those people with the most serious health problems."

Wyden noted another crucial element to fundamental reform that is linked to the HAA is a need for personal responsibility, meaning virtually everyone will have to pay something for their healthcare, and one is essentially enrolled when they become employed via the tax code. Currently, Wyden said guaranteed government subsidies are being squandered on costly emergency room care, when they should be used for prevention and primary care. "We have worked best as a nation when we have linked rights and responsibilities and I think that is a key element of reform as well."

While some have argued for a single-payer system in the U.S., he said he believes that is "more than the country or Congress would accept."

Wyden said he believes that people in this country are ready for bold changes in healthcare "provided they are carefully explained." He added that healthcare costs in this country will never go down until workers see what they are losing out on in terms of take-home pay and are given the opportunity to gain as the result of a cost-effective purchase.

"We do both of those things in the Healthy Americans Act," he said. "We're trying to realign the incentives so that healthcare choices in America can be, or at least resemble the kinds of choices we make everywhere else, where people really do have a greater sense of personal involvement."

Urology/gynecology a sector of interest

One of the sessions at the gathering focused on innovation in an area not previously highlighted at this gathering, the urology/gynecology segment.

Enlightening the audience as to the value of this space was Karen Licitra, company group chairman of the Ethicon Endo-Surgery (Cincinnati) unit of Johnson & Johnson (New Brunswick, New Jersey). She said that from treatments in fertility, incontinence, erectile dysfunction to the invention of laparoscopic and endoscopic surgery "urology and gynecology have been at the forefront of technological advancement."

The question, of course, is what is the future of innovation in this field? "Consider that every three seconds, someone in the world turns 65; that's 25,000 new seniors a day," she said. "And that translates to a continually growing population of patients needing treatment for gynecological and urological conditions."

Licitra said she believes that the opportunity for urology and gynecology market is "there for the taking." But to be successful, she noted that the medical device industry will have to "change our paradigms about what makes medical innovation, the kind of innovation that drives market creation in today's healthcare environment."

To achieve successful innovation in today's market she said that technology must be combined with information, service, education and ultimately patient outcomes. "That will be the difference between a market-share play or a market-creation play."

Fortunately for companies working in this space, said Licitra, is the willingness of physicians in the sector to try out new technology. She noted that gynecologists and urologists have developed and used some of the most beneficial and frequently used technologies of the past 20 years.

"From ultrasound to MRI, laparoscopy and endoscopy and robotics, the industry has understood how to make use of the benefits of newer procedures and improve upon those procedures in helping to diagnose and treat patients," she said. "So clearly innovation is embraced by these specialties."

According to Licitra nearly 4 million urological and gynecological procedures are performed in the U.S. alone, with a similar number estimated for Europe. She said that a recent report by the Lewin Group found that roughly one-third of U.S. women will have a pelvic health problem by age 60. Spotlighted by the report were the specific areas of abnormally heavy periods, uterine fibroids, pelvic organ prolapse and stress urinary incontinence.

Licitra said that urinary incontinence is the most common urological ailment affecting both men and women with nearly $18 billion on diagnosis, pretreatment and surgical or behavioral procedures. Nearly 14 million Americans are affected by urinary incontinence and more than 800,000 cases of urinary incontinence are diagnosed in the U.S. each year.

Stress incontinence continues to be the most common form of the condition for women and surgery is still the primary method of treatment as Licitra noted that there is currently no pharmacological treatment for this type of incontinence.

She said that the urological surgical device market was valued at more than $178 million in 2004 and that number is expected to rise to more than $520 million in 2011, a compounded annual growth rate of 16.6%. "Most of this market is derived from the treatment of incontinence in the aging Baby Boom generation."

In the gynecological device market, she said that ablation procedures will continue to be a "driving force." In 2005, the total thermal ablation market was estimated at almost $400 million. This is expected to remain a very robust market, growing to more than $659 million by 2010, influenced by changing treatment guidelines and more physicians transitioning to performing procedures in their offices.

Despite the fact that pelvic organ prolapse (a hernia of the bladder, uterus or bowel) affects up to half of all women age 50 or older, Licitra said that the market is underpenetrated, with only about 225,000 surgeries performed in the U.S. annually because women are often embarrassed about the condition and are often reluctant to seek treatment despite the pain. Because of this, the market in this area, currently valued at about $60 million is only expected to grow to about $95 million by 2012.

Another market of interest is that of prostate cancer, with 182,000 men diagnosed with the condition in the U.S. and nearly 29,000 die from the condition. The good news is that early diagnosis and more affective treatment have increased the five-year survivability of the condition over the past 20 years from about 67% to nearly 100%. About $650 million is spent annually to treat the condition.

Another male condition that promises to have a markedly increased market is that of benign prostatic hyperplasia (BPH), with nearly half of all men in the U.S. being identified as having the condition by age 60 and by age 85, the prevalence is about 90%. Over 300,000 surgical procedures are performed every year to treat BPH. The overall market for BPH in the U.S., including drugs is expected to grow from $1.4 billon to $3.4 billion by 2011.

As for the future of the urology/gynecology market, Licitra said that not only will less-invasive be the ticket to entry, but advancements will likely be driven by technologies such as nanoparticles, imaging, miniaturization and electronics.

A recent innovation in treating uterine fibroids is MR-guided focused ultrasound (MRgFUS), in which the MR images give the doctor the precise location of the fibroids while the focused ultrasound transducer sends focused soundwaves into the fibroid to heat and destroy small areas of tissue.

This procedure, she said, is less costly than conventional surgery requires no overnight hospital stay, uses no general anesthesia, doesn't require an incision and it preserves the uterus.

Another interesting technology being talked about at the summit is Doppler-guided uterine artery occlusion that is intended to allow a gynecologist to treat a uterine fibroid using a minimally invasive surgical approach that temporarily shuts off blood flow to the uterine arteries. The device is currently under development and is undergoing clinical trials.

Another area that holds much promise is the area of robotics. Nowhere is this more evident than in urology, where robotically-assisted radical prostatectomy now accounts for 40% of all radical prostatectomies in the U.S.

Licita said that while the promise of this new technology is great, "industry needs to do a much better job of promoting it and helping to obtain reimbursement for these technologies."

She also noted that it is no longer okay just to show safety and efficacy for new technology. For wide adoption, clinical trials "must also prove superiority and cost-effectiveness versus existing treatments."