Sometimes news comes in bunches. That’s not typically the case in the month of August, which is ordinarily a pretty quiet month. Not this year, though. Here are three stories that stick out, in one case like a sore thumb.
Post-market studies for ICD leads
FDA announced it will require section 522 studies for a range of ICD leads made by St. Jude Medical. This is not the first time the new FDA has required 522 studies for groups of devices as the 522 orders for surgical meshes, hip implants, and dynamic spinal stabilization systems suggest. I might add that companies whose wares have not presented statistically significant problems have been forced into the 522 march.
The lesson here is that a post-market 522 study is now the quasi-official FDA response to device problems that are not already tracked in a very extensive registry, and industry knows it. What will industry think about investing in the U.S. in the years ahead once they have to factor the cost of these studies into the product life cycle?
Hauser’s paper on abrasions: a correlation with extrusion?
Robert Hauser, MD, recently published in Europace on the matter of abrasions to St. Jude leads coated with the Optim co-polymer material. It’s another piece of news that could spell danger for patients and for the company … or not.
One thing Hauser’s piece did not explain was whether a correlation exists between abrasion from external sources and externalization of conductors. Maybe there aren’t a lot of data on this. I can’t seem to locate anything on this for ICD leads in general, let alone anything specific to the Optim coating. Will it turn out that the correlation between abrasion and externalization is puny?
One of the difficulties behind this discussion is that there are a lot more patients around who have had an ICD for some years than there were in times gone by. Consequently, electrophysiologists are cramming these skinnier leads into some spaces where there is already a lead that has gone kaput. Ergo, a higher rate of abrasions and externalizations might be partly or even principally due to the contortions a lead is exposed to in order to cram it into a tight anatomical space.
This is not a meaningless consideration. If there’s already a lead in there and you as a physician always resort to a skinny lead to replace a dead lead, the narrower lead already has a problem.
So before we wish skinny ICD leads out of existence by beating the daylights out of St. Jude, maybe we better find out if there is a correlation between abrasion and extrusion, and whether these leads are being used in ways that make it tough to avoid problems to begin with.
NEJM article on NIH spending
I mentioned at the outset that one of these three stories stuck out like a sore thumb. Here it is.
Those who have watched the MDD Perspectives blog for some time know how annoying I find the entire NIH funding discussion. Well, it’s still annoying.
I won’t carp about the cancer-versus-Alzheimer’s funding thing, but the authors of the paper on NIH spending in the Aug. 23 edition of the New England Journal of Medicine use advances in heart disease to justify more spending at NIH and the National Science Foundation. But really, doesn’t the medical device industry deserve most of the credit?
Another point raised in this and other arguments like it is that people with PhDs and MDs will find themselves unemployed. Well, there’s a lot of that going around lately and it’s no reason to throw taxpayer money at medical research. By that logic, anyone with a PhD in particle physics or a JD in constitutional law deserves to be employed via federal funding just by virtue of having a sheepskin. You never hear anyone sweating bullets over someone with a Bachelor’s degree in criminology, but if you have a PhD in a life science, well by golly, pull up your chair to the trough!
I dare someone who supports gobs of money for NIH to say “FDA needs it more. We’re okay with NIH funding where it is.” Why will that never happen? Because possession of a PhD does not blunt self-seeking behaviors even a tiny bit.
Funny how human nature never changes, isn’t it?
Having grown up in a small rural town in South Carolina, I can attest to the fact that sometimes your choices for service are usually few and far between.
Typically, there's only one of anything, and if you want to check out a competitor be prepared to drive at least 50 miles out.
This is the case especially when it comes down to healthcare needs.
One of my family members is now in a position where she sees a specialist who is about 60 miles away. Every Tuesday she dreads that long commute, which is reflected through her blood pressure tests.
Unfortunately, there's not a specialist tailored toward her needs in my hometown.
One of the greatest issues often forgotten in healthcare, are rural areas with little or no physician penetration. The access to quality care and the ease of choice to select a physician best suited for your needs are the two biggest roadblocks people face in rural areas.
Many times you're "grandfathered" into the only practicing doctor around - and when things become difficult you're referred out to a 'specialist' nearly 100 miles away.
Perhaps the answer to all this is telemedicine -but the problem truly won't be solved until there are more options for care in rural areas.
A few years ago Brad Paisley released “Welcome to the Future”, a song about all the changes he has seen in his lifetime and how some of the capabilities we have at our fingertips now, in terms of information technology, was merely a dream not that long ago.
Paisley’s song has always struck a chord with me, pardon the pun, because our world is so fast-paced we don’t often pause long enough to think about the progress we have made.
The same could be said for the medical device industry. A lot of devices that are in doctors’ hands today, or are coming down the pipeline, not long ago seemed like science fiction.
I almost dread to list examples, knowing that as soon as I do I’ll get a hundred emails from companies whose “sci-fi” like technology wasn’t mentioned. But I’m going to do it anyway. Just note that this is in no way a comprehensive list, but a few examples of how far this industry has come.
The first that comes to mind is robotic surgical equipment. We have robots capable of doing some of the necessary but tedious steps of a procedure, such as sutures, freeing up the surgeon to apply his or her expert skills on more complex tasks. The da Vinci system fromIntuitive Surgical (Sunnyvale, California) is perhaps the best known of its kind, but the field of robot-assisted surgery is growing and Intuitive is certainly not alone in the space.
Last year I saw firsthand a robotic system in development atThe Hospital for Sick Children (SickKids) in the heart of downtown Toronto. The KidsArm system is designed for pediatric surgery and is a joint development by SickKids and MDA Robotics (Brampton, Ontario), the company that built the Canadarm space arm for the Space Shuttle.
The KidsArm is being developed to stitch patients up at a much faster pace than a human could and is expected to weigh somewhere between two and 200 pounds, compared to the much larger da Vinci, which weighs about 1,200 pounds. But the KidsArm is more than just a scaled-down version of the da Vinci.
The KidsArm is being dubbed as a “smart” robot, because the control system is actually done electronically and the only information that the robot has is what’s coming from two pared video cameras that give it depth perception. So, if something moves, or changes, in mid-operation, the robot can adapt. The researchers have set a high goal for the system, wanting it to achieve ten stitches in ten seconds. The same job would take a surgeon about an hour to perform.
As Brad would say, welcome to the future.
Moving on to the ophthalmology space, a company calledVisionCare Ophthalmic Technologies (VOT; Saratoga, California) is implanting telescopes into patients’ eyes to improve visual acuity. The company launched the Implantable Miniature Telescope just this year, though it received premarket approval from the FDA in 2010. The telescope is indicated for patients 75 or older with stable, severe to profound vision impairment associated with end-stage age-related macular degeneration.
There are certainly more examples ranging from bionic eyes to artificial heart valves and other artificial body parts and organs. The point is, this industry has a lot to be proud of and having seen how far we’ve come in my thirty-some years, I am eager to see how far we advance in the next thirty years.
Welcome to the future!
It's not always doom and gloom in the med-tech industry. Some med-tech companies are making significant strides, and it doesn't always revolve around garnering a significant funding or getting FDA approval on a product.
Nearly two months ago, Instrumentation Laboratory (Bedford, Massachusetts) took a bold leap with its Hemostasis product line in North America, and decided to go with a new direct sales, support and service model.
Previously the company had a strategic alliance cross-distribution agreement with Beckman Coulter (Brea, California) for about 20 years, which it deemed successful. The company already has a direct customer model in its critical care line.
In a brief discussion with Medical Device Daily, the company said that this was a natural and organic move that would only benefit the customer.
"It was a really highly successful alliance [with Beckman Coulter] for 20 years," Brian Durkin, Instrumentation Laboratory's VP. "It was just a natural logical flow to take the business direct. We feel like similar to what we did on Critical Care we could better serve our customers on a direct basis."
Kudos should be given to Instrumentation Laboratory. The firm is in a position to have a more direct impact in the Hemostasis market, and will perhaps demonstrate significant growth within the next few months because of this measure.
Oscar Pistorius didn’t win a medal in the just-concluded Olympic Games. Not a gold, not a silver, not a bronze. In fact, he finished last in his semifinal heat of the 400-meter run (I think they call it the 400-meter dash, although I can’t fathom any race that requires one full lap around the track being called a dash), and his South African relay team finished next-to-last in the finals of that event.
But the 25-year-old Pistorius leaves quite a legacy behind in London, and not just because he became the first double-amputee athlete to compete against normal, able-bodied athletes in an Olympics. For me, that legacy is far more than the fleeting notoriety that would come even had he stood atop the medals stand.
The lasting picture for me is of Pistorius perched atop a pair of carbon-fiber legs, or blades, and it is not so much a picture of him running on a world stage -- it is more what those blades represent, and that is yet another triumph of medical engineering.
In an age where heart transplants – once the “ooh, aah” stuff of front-page headlines – are so commonplace that we read of them only when there is a celebrity recipient, seeing someone who lost both lower legs to amputation at 11 months of age be very competitive against able-bodied rivals is just short of amazing.
And the only reason it isn’t fully amazing is that I have spent nearly 20 years reporting on developments in medicine that I would have considered nigh on impossible back when I was a young reporter who had occasion to interview such medical luminaries as polio vaccine developer Dr. Jonas Salk and heart transplant pioneer Dr. Christiaan Barnard.
Pistorius, dubbed the “Blade Runner” by the oh-so-clever folks in the sporting media, is the face – or rather, the feet – of a revolution in prosthetics that brings new hope, new life for thousands of persons who now are able to receive replacement limbs thanks to the efforts of medical innovators. Those researchers have focused their energies on improving the quality of life for persons who have lost limbs to birth defects, accidents or traumatic wounds suffered on the battlegrounds of Afghanistan, Iran and other war zones worldwide.
What they have accomplished, especially over the past decade or so, was exemplified by Pistorius dashing around the Olympic Stadium track, with hundreds of millions of eyes on him via worldwide television, watching with presumed wonderment at how he was able to make it all seem so very normal.
I am exposed in a small way to the world of prosthetics and even though that exposure is slight, I nonetheless am amazed by it. I wear custom-made diabetic shoes, and so am fitted for a new pair annually at a local orthotics/prosthetics company. While going for the fitting and subsequent delivery of each new pair, I often encounter in the waiting room wearers of various types of lower-limb prosthetics. In fact, the tech who has fitted me for shoes over the past several years is himself the wearer of a prosthetic lower leg and foot, and I say with considerable admiration that he moves around the fitting room infinitely more spryly than I do.
He clearly demonstrates to me that in the world of prosthetics, the watchword seems to be, to borrow the 2008 Obama campaign slogan, “Yes we can.” Or maybe Nike’s “Just do it” mantra.
The U.S. Paralympics team’s lead prosthetist, Francois Vanderwatt, talked with USA Today about what the Pistorius breakthrough means in the world of the physically challenged. “What this does for disabled people all over the world is it challenges their minds to start thinking about what is possible and not what’s not possible.”
And that “mind over matter” mentality exists in no small measure thanks to the fact that medical innovators took the same kind of approach. Where some may have seen impossibility, they saw opportunity. Where some saw a life of despair for those having suffered such traumatic injuries, they saw ways to make hopes a reality.
Hats off to them, and I join in with the heartfelt thanks that are uttered every day by those who are able to enjoy pretty much normal lives thanks to the marvelous products that have been developed by these innovators.
(Jim Stommen, retired executive editor of Medical Device Daily, is a freelance writer focusing on healthcare issues.)
By Steve DeatonMDD Perspectives Contributing WriterEditor’s note: Steve Deaton is the vice president of sales at Viztek, aprovider of complete digital software and hardware imaging solutions for the med-tech industry.In healthcare there is an evolving trend of making data accessible and easily sharable, and this change is being enabled through cloud-based infrastructure.. The cloud eliminates the need for on-site server space and maintenance through virtual servers that are both secure and flexible. A broad shift to cloud services in healthcare will have multiple implications for both physicians and their patients.
The Cloud Brings Changes for Patients and Physicians
Many cloud-based systems are simply easier to use than traditional legacy solutions. These new solutions are web-based, so if users can navigate web pages or Google, they can quickly learn how to use the latest healthcare solution. The training curve and related expense is simply much lower with the cloud-based applications.
The cloud also changes the makeup of different user levels within a healthcare organization. Typically, a company would procure a new server-based solution and then one or two super-users would gain a certain level of expertise with the intricacies of that solution. They are then expected to share knowledge with other users, perform fixes, and to recognize failures. With a cloud-based system, nearly all of the users become “intermediate” level. The super-users still exist; they are just now with the cloud hosting vendor and represent a large group of technical people that the facility end-users can speak to in order to best use the solution. This dynamic drives adoption of the system throughout the healthcare organization, an especially important step for organizations with various regional locations.
Traditional systems that require on-site servers mean that practices or hospitals are largely responsible for keeping them running. They need a dedicated and cooled server room, and are accountable for any problems with the physical hardware. The cloud eliminates these concerns, by eliminating maintenance and various physical risks that could affect uptime.
For physicians, the cloud represents the fast accessibility of data. Doctors can pull up various types of information from their tablet or mobile device, now including patient records. Cloud-based healthcare applications allow information about the practice to become a part of the physician’s daily informational diet. Immediate access to information means physicians can always make the quickest and most informed decisions about patient care, especially if they are not physically present in the office. In the business realm, collaboration platforms such as SharePoint and CRM solutions like SalesForce are fully in the cloud. They enable remote access for staff and partners to communicate shared real-time content. Healthcare is moving toward this structure, where the cloud is promoting the sharing of information between physicians. Such a solution enables medicine to be collaborative, as geographic boundaries are eliminated and consultations no longer need to be conducted in-person. A physician in New York simply provides her Buenos Aires colleague with a user name and password, and they can both view information such as X-ray images in order to discuss an anomaly or the recommended course of treatment.
From the patient perspective, cloud-based solutions provides patients with greater access to their own medical records. Patients are able to access secure systems through the cloud where they can pull their information and then send it to a referred physician or other entity as needed. Another instance of the cloud is in patient referrals, with some companies emerging that will allow patients to ask for second opinions through a cloud-based system that routes their information to a physician of their choice for a flat fee, so they can get another opinion without having to schedule an in-person appointment.
As the underlying technology of cloud services continues to fall, and as security and reliability continue to improve, more solutions and practices will be moving their critical systems to cloud structures. Such solutions are much more flexible, and can feature dynamic pricing which can rise and fall to meet demand and eliminate the need for initial and ongoing capital investments in equipment and IT staff.
By Kelly Roman, Vice President of Fisher Wallace Labs
On February 10, 2012, the FDA convened an advisory panel hearing on whether to reclassify cranial electrotherapy stimulation (CES) devices. Despite being a low-risk device, CES has lingered in Class 3 (high risk) for more than 30 years as a result of being a grandfathered 510(k) medical device. The regulatory fate of CES, which is currently cleared to treat depression, anxiety and insomnia, will emerge at a time when antidepressants have been proven ineffective in treating soldiers with post-traumatic stress; CES has had great success treating this population. CES manufacturers such as my company will not survive the PMA process, and soldiers will lose access to CES should the FDA decide reclassification is unwarranted.
As the panelists took their seats, my business partner and I realized that Dr. Alvaro Pascual-Leone, professor of neurology at Harvard and director of the Berenson-Allen Center for Noninvasive Brain Stimulation, was missing from the panel. Our hearts sank – he was the only panel member with actual experience in non-invasive brain stimulation. He had even received a waiver from FDA to appear on the panel as a result of his irreplaceable expertise. Dr. Pascual-Leone was “unable to attend,” FDA’s Avena Russell announced to the crowded auditorium. Weeks later, we discovered this wasn’t true.
Without Dr. Pascual-Leone, the panel delivered a highly divided vote, which, by a slim margin, sided against reclassification. The dissenting panelists, while acknowledging that CES is safe, expressed discomfort with the fact that the vast majority of our effectiveness research was conducted between the 1960s and 1990s. There was little incentive to fund contemporary, large-scale studies for a device that the FDA provided marketing clearance for in 1977, especially since no one had ever been injured by the device.
Five panelists believed we had proven CES safe and effective and deserving of reclassification, including Dr. Suresh Kotagal from Mayo Clinic and Dr. Richard Fessler from Northwestern. They were swayed by our well-controlled studies (albeit most pre-1995) and decades-long safety record. More than 600 board-certified psychiatrists currently prescribe our device.
Dr. Pascual-Leone may have voted in favor of CES reclassification (a fair assumption given his long-standing support of therapeutic non-invasive brain stimulation) and his expertise may have convinced one or more of the dissenting panel members that CES should be reclassified. His absence had an enormous negative impact on our bid for reclassification.
It was obvious from their presentation at the hearing that FDA’s Malvina Eydelman and her team were determined to prevent CES from being reclassified. They went so far as to exclude 229 published studies on CES from consideration by applying biased exclusion criteria that did not reflect the regulatory definition of valid scientific evidence. For instance, they excluded all CES research that was not performed on humans. Since when are animal studies not accepted as valid scientific evidence?
“Lets contact Dr. Pascual-Leone and find out why he did not attend,” I suggested to my business partner, Chip Fisher, after the hearing. Chip emailed Dr. Pascual-Leone who informed us that he was, in fact, able to attend the hearing but was instructed not to show up by the FDA a few days prior. My jaw hit the floor. The FDA had removed him and then lied about the reason for his absence.
Our Citizen Petition details this FDA misconduct but does not speculate on motive. I am reminded, however, every time I pick up a copy of Psychiatric Times that nearly all mental-health advertising is from Big Pharma. Last month, Psychiatric Times (aka PT) published an article titled "FDA Panel Votes to Curtail CES.” The full-page article never mentioned Dr. Pascual-Leone or the controversy surrounding his removal from the panel. I emailed PT’s editor-in-chief, Dr. James Knoll, and asked him why the article ignored the FDA misconduct. His emailed response to me ended with:
“Finally, for PT to delve into the issues surrounding Dr. Pasual-Leone would require an investigation and time investment that exceeds the depth and detail that we wished to communicate in this relatively brief news article.”
What does Dr. Knoll’s staggering admission say about the integrity of PT’s other articles? What does the FDA’s manipulation of our panel say about the integrity of other FDA hearings? CES is the only medical device on the market cleared to treat anxiety and insomnia – everything else is a drug. We manufacture our devices in New Jersey, not overseas, and our patients, more and more, are American soldiers in need of non-drug therapy. Unfortunately, we may be doomed if no one is watching the watchmen.