‘Tis the season to be thankful and slice into a roasted turkey with family and friends. In the spirit of the occasion, here are a few things I’m thankful for, and a few turkeys I think we could all do without.
Some of the retooling of the device review process at FDA’s device center. These changes were long overdue, but we should acknowledge the agency’s budget was pretty flat for large parts of the first decade of this still-young century. It’s not easy to overhaul something on a flat budget, especially when it’s flat even before accounting for inflation.
Not thankful for:
A personnel review system that failed to filter the malcontents who were working at the Office of Device Evaluation (cough*RobertSmithMD*cough) until relatively recently. There were evidently a number of “activists” who believed they knew better than everyone else and started firing off letters to Congress and the White House in an effort to stir up trouble.
On the other hand, I’m thankful that these pea-brains are either gone or have decided to do something about their obviously delusional thinking. Here’s hoping they vet their new hires a bit more exhaustively.
The three troublemakers who brought us thehealthsherpa.com. They proved that websites designed to handle complex healthcare transactions can function if one avoids larding the project down with layers of bureaucratic groupthink and endless consultations to ensure that each of the dozens upon dozens of “experts” is nodding approvingly and saying harrumph in unison (as Mel Brooks said in Blazing Saddles, “I didn’t get a harrumph out of that guy!).
They also proved you don’t have to shamelessly fleece the taxpayer in the process.
Not thankful for:
Healthcare.gov. Half a billion dollars is not your average boondoggle. It’s a boondoggle of epic proportions and will go down in history as a verification of all the suspicions many Americans rightly hold regarding the U.S. federal government’s “competence” and ethics. After all, this is the same administration that obtained the phone records of the parents of a journalist (yes, the parents of a journalist) in one of the most brazen and cynical moves by an American law enforcement agency since J. Edgar Hoover ran the FBI.
Companies like St. Jude Medical, which has gone out of its way to cooperate with doctors and FDA on the problems associated with the Riata EP leads. The doctors I’ve talked to have said almost in unison that St. Jude was a model of corporate citizenship. Hats off to the leadership there.
Not thankful for:
The idiots in charge of Poly Implant Prothèse, the firm that used industrial-grade silicone in breast implants. The authorities in the various jurisdictions affected by this scandal have different views of how toxic the silicone they used may or may not be, but the PIP scandal became the rallying cry for those who want to put Europe on the same footing as the U.S. where stringent device reviews are concerned. Thus device lag is likely to affect more than just American patients, now.
Happy Thanksgiving to all, and safe travels.
It is fall here in the U.S. and, for many Americans, that time of year brings cooler weather and football. Apologies to our non-U.S. readers, I realize that you have ownership on “real” football, and our version is secular at best. But, hey, football is ours and we sure do like it.
It is during this time I like to reflect and “brag” that I have something in common with arguably one of the greatest quarterbacks to play the game – certainly in the modern era. You see, Peyton Manning and I share a common bond. No, my father wasn’t an NFL quarterback, I wasn’t an All-American quarterback at Tennessee, and my little brother hasn’t won two Super Bowls. Peyton and I both had identical cervical neck fusion surgery – and since then have both lived productive lives.
A quick history lesson. Manning opted for the fusion surgery in September 2011 after battling past problems with a bulging disc in his neck. There was no direct incident attributed to the injury, but no doubt the slings and arrows of his chosen profession were spotlighted. Manning sat out the whole 2011 season, and was subsequently released by his NFL team, the Indianapolis Colts in early 2012. Concern surfaced about Peyton’s ability to regenerate the nerve damage that had weakened his right (throwing) arm. But, given time, the nerve slowly regenerated. Imagine it like when your foot “falls asleep.” The nerve is pinched slightly and takes a few painful minutes to get back to normal. Manning’s neck had been like that for five years or more.
The Denver Broncos decided to take a chance on Manning and he was officially declared ready for the 2012 season. NFL fans nervously waited for him to take his first hit. Would he get up? Is his arm back to full strength? After an injury-free 2012 (including a trip to the playoffs), Manning is back better than ever in 2013. He threw for 400+ yards and 7 touchdowns in the Broncos’ opening game and is leading the NFL in QB rank. Many argue that he is better than ever, and the neck is in fact stronger than before surgery.
I had my surgery in March 2007, and it was the final stop for me following a year of cortisone injections, epidurals, physical therapy, pain meds, chiropractic treatment, and general frustration. Like Peyton, there was no direct cause of the bulging disk. Perhaps it was when I raked that last leaf in the yard, walked that extra block with the dog, moved the TV to another room? It doesn't matter. I was back to work in a month, and my right arm regained its strength, and although I don’t have to dodge NFL defense men, I hit the golf ball longer off the tee now than I ever did pre-surgery. I might have a tingling in my middle finger every now and then, but nothing serious.
What always amazes me is how far medicine, technology and surgery has come today. I often read or edit a story for Medical Device Daily featuring a new technology or an emerging company that is seeking funding for its new invention, and I think of how lucky we are to live in this day and age when medical technology is constantly improving. The research and development teams at device companies and universities is exciting. My surgeon told me that if it were 10 years earlier, I would have had “a chunk of metal” in my neck instead of the two miniature titanium plates. And my recovery would have been much more difficult.
So, for now, I am just glad that on Sunday afternoons my brother in surgery Peyton and I are in our rightful places – he on the playing field and I at home watching him from my couch.
America is the fattest country in the world. The obesity epidemic is one of the largest problems facing the healthcare system, both from a clinical and an economic perspective. Pardon the pun.
The Centers for Disease Control and Prevention reports that more than one-third of U.S. adults (35.7%) are obese. Because obesity is associated with so many other health problems, such as heart disease and diabetes, the topic has drawn a great deal of attention at industry gatherings, including the Cleveland Clinic Medical Innovation Summit last month where the clinical focus was on obesity, diabetes, and the metabolic crisis.
But recognizing that obesity is a problem is only half the battle. Finding a solution to this problem, which affects both children and adults and creates an overwhelming drain on healthcare resources, seems to be easier said than done.
“We just need one winner,” Philip Schauer, MD, the director of Bariatric & Metabolic Institute at the Cleveland Clinic, told me at a networking event during the Medical Innovation Summit.
The bariatric device space came close to declaring a winner a few years ago with a technology that is no longer in development. Satiety (Palo Alto, California) had developed the Trans-oral Gastroplasty, or TOGA, procedure. That procedure involved the creation of a gastric sleeve so small that when even little amounts of food entered and pushed against its wall, the patient felt a sensation of fullness. Satiety got as far as completing a pre-market approval study in the U.S. and the TOGA procedure even landed on the Cleveland Clinic’s prestigious Top 10 list of innovations expected to make a big impact on healthcare in 2011. But when less-than stellar weight loss results came in, the company was shut down.
All hope is not lost, however. I recently wrote about ReShape Medical (San Clemente, California), a company trying to bring a non-surgical weight-loss device to the U.S. market. ReShape reported earlier this month that its REDUCE trial for its ReShape Duo Intragastric Balloon met its primary efficacy endpoints. That makes ReShape the first company to meet its primary efficacy endpoints in a U.S. randomized, sham-controlled pivotal trial for weight loss.
ReShape plans to submit a pre-market approval application to the FDA in the second quarter of 2014. Richard Thompson, president/CEO of ReShape Medical, told me there was significant interest in participation in the study, which speaks to the clear need for a product like the ReShape Duo balloon. The balloon is endoscopically placed down the esophagus and into the stomach without requiring any incisions, sutures or fixation to the body. Once in place, the balloon is inflated with saline and designed to take up much of the stomach’s volume, causing patients to eat smaller portions and to feel full sooner. The device does not change or alter the patient’s anatomy, and is fully reversible. The balloon is removed after six months.
What I think is interesting about this procedure, aside from the incision-free aspect, is the fact that the device is intended to help patients achieve a healthy weight, but the patients are still expected to work with dietitians, doctors and nurses to learn healthy diet and exercise habits during and beyond the treatment period. The device could go a long way towards bridging a very large gap of patients who are eligible for bariatric surgery but refuse to consider that as an option.
Interestingly, Thompson pointed out that fear of surgery is only part of the reason so many patients decline the surgical weight loss option. Many patients simply want to feel like they are solving the problem on their own, rather than feel like they are giving up by having surgery. For those patients, ReShape could be the help they are looking for without any stigmas they might have regarding surgery.
The first thing that hits you when you walk in Elekta's Learning and Innovation Center (LINC) located in Atlanta, is that there is a lot of history here.
From the Leksell Stereotactic System invented in 1949, to the Leskell Gamma Knife Perfexion - the advances in med-tech through the lens of a once small but now sizeable company are evident.
But to merely think of this as a repository of the firm's greatest technological achievements and advancements in the treatment of cancer would be egregiously wrong. LINC is a learning center that links the past to future innovation.
The 25,000 square foot facility that boasts lecture rooms and all of the firm's latest technology is instead a learning destination. LINC was launched during the American Society for Radiology (Fairfax, Virginia) meeting held in Atlanta in September. Last month, Medical Device Daily toured the facility, which boasts some of the companies flagship technology, such as the new Versa HD linear accelerator and Leksell Gamma Knife Perfexion. Enhancing the experience, students have access to the Versa HD vault, which is large enough for hands-on learning.
"Elekta's really putting forward education and training for patient safety as a first priority," Ian Dickson, Elekta's CFO, told Medical Device Daily. "The company has grown so rapidly in the last four or five years – there's been a lot of organic growth but also through acquisition. Our education programs are pretty dispersed around the U.S. so we saw this to really get the value proposition and to put safe training and education on the map for us as an organization into the radiation community we needed to centralize it, and that's what we did by bringing it here into the Perimeter area here in Atlanta."
Simply put, Elekta is on the right path to innovation. You can't go forward without investing in the future of your technology. Giving healthcare professionals the advanced training that they might need on Elekta's wide array of products accomplishes that goal.
[caption id="attachment_2920" align="alignleft" width="232"]A third of a dollar isn't what it used to be, is it?[/caption]
When it comes to coverage and reimbursement, there are gatekeepers all over the place, but some keep bigger gates than others. Following are two stories about the Centers for Medicare & Medicaid Services and how it has kept its gate in recent weeks.
CMS not wild about MILD
CMS recently took it upon itself to review percutaneous, image-guided lumbar decompression for stenosis, proposing on Oct. 17 that it sees the evidence as insufficient to prompt coverage.
Among the references found in the coverage proposal is one addressing the MILD procedure by Vertos Medical, a company that is no doubt pulling out all the stops to get CMS on board. The agency said most of the evidence in support was provided by case series, and the only randomized, controlled trial “had a small enrollment and major design flaws.”
CMS also said it has “questions about missing information, questions about adverse events and conflicts of interest,” concluding that the evidence “does not support a conclusion of improved health outcomes.”
So it doesn’t look good. Still, we might bear in mind that more than 100 people sounded off on the treatment, the vast majority of which were supportive. Even if CMS passes, this won’t be the last we hear of MILD and PILD.
Heart failure? VAD you asked
CMS also recently published a coverage memo for ventricular assist devices, which among other things declared the Intermacs registry a dinosaur. The problem here is that the age of mammals has yet to arrive where a replacement registry is concerned, so T. Rex reigns until further notice.
Perhaps the most significant aspect of this coverage memo is that CMS seems to have pried open enough space for those bridge-to-decision patients with a passage stating that the agency has removed the word “permanent” from the language dealing with VAD for destination therapy.
Doctors seem to be of the view that CMS left a lot of ambiguity in its rewrite of the coverage manual, and the term “destination therapy” will now include a much more varied population. Still, where there’s fuzziness, there’s latitude, and what was a bad state of limbo for some heart failure patients now becomes a haven, and the docs have to deal with limbo, which frankly is a task they’re paid to handle.
All in all, it sounds like an improvement for heart failure patients, and an especially welcome bit of news for a patient population that is in desperate straits.