The Heart Rhythm Society annual meeting is arguably the most important conference for big cardiac medical device makers like Medtronic Inc. (NYSE: MDT), based in Fridley, Minn., and Boston Scientific Corp. (NYSE: BSX).
It’s an ideal forum for companies to release significant clinical data: Medtronic, for example, Thursday demonstrated methods to reduce accidental shocks from implantable cardioverter defibrillators (ICDs).
With all due respect to Medtronic, it was one small company in California that stole some major thunder even before the conference began. Cameron Health Inc., based in San Clemente, announced promising results from a clinical study testing the first of its kind ICD: a subcutaneous system without any leads (wires connecting the pulse generator to the heart).
The study earned significant ink in both the New York Times and the prestigious New England Journal of Medicine (NEJM). It’s not hard to see why.
A traditional ICD system consists of a battery-powered pulse generator connected onto the heart through thin wires snaked through the patient’s veins. The system detects abnormal electrical activity in the heart and shocks it back into rhythm.
Cameron’s entire system is implanted just under the skin in subcataneous tissue. In the NEJM study, which tested several configurations, the pulse generator was ultimately placed over the sixth rib between the midaxillary line and the anterior
axillary line. From the pulse generator, an electrode, consisting of a shocking coil and two sensors, were placed vertically on the sternum, the breast bone that protects the heart.
Researchers, led by the Seattle Institute for Cardiac Research, conducted a pilot study of six patients followed by a long-term trial of 55 patients throughout Europe and New Zealand. The results showed the Cameron system successfully detected and treated all 12 episodes of spontaneously induced ventricular tachyarrhythmia, or abnormally fast rhythms in the lower chambers of the heart.
The authors crowed the system could potentially eliminate situations like Medtronic’s Sprint Fidelis woes, in which faulty wires resulted in errant shocks to the heart.
“In the long term, lead failure remains a major limitation in the use of ICDs, despite decades of innovations in lead design,” the study said. “Lead failure either generates inappropriate shocks or impedes appropriate therapy. Moreover, failed leads often require removal, a procedure that is associated with substantial morbidity and mortality. If cardiac pacing is not necessary, there may be a clinical advantage in avoiding the use of transvenous electrodes.”
Yet the technology was not received well among some in Minnesota’s medical device community.
“It’s bull****,” one former top medical device executive grumbled. “I don’t know any [doctor] who would use it.” He noted the pulse generator and shock coils were much larger than traditional ICDs and required much more energy.
Ross Meisner, managing partner at Dymedex Consulting in St. Paul, was a little more diplomatic.
“It’s certainly a new way of implanting ICDs,” he said. “But whether it has a large impact on the ICD market remains to be seen.”
Meisner said the technology, which has been discussed for years, could benefit small groups of patients like the elderly and children with vascular problems. But he doubts it will present a serious challenge to companies like Medtronic and Boston Scientific.
I’m not a medical device expert, but I do think Cameron’s system is a bigger deal than some people think. First of all, the NEJM study is simply the beginning — much more study is needed before the Food and Drug Administration approves such a device. The study notes it can’t prove the system is superior to traditional ICDs — yet.
However, the trial proves the technology’s basic premise — successfully detecting and shocking errant heartbeats — works. True, the device has limitations, including its size and energy consumption. But aren’t those the same criticisms lobbied at ICDs when they debuted in 1980? Over time, engineers found ways to shrink the ICD and its power needs. So why can’t they do the same for Cameron’s device?
More importantly, the potential benefits can’t be ignored.
Medtronic’s spent several years and millions of dollars to develop its next generation Sprint Fidelis leads. Yet in 2007, the company stopped selling the lead after reports the wire broke apart inside the body. Countless lawsuits from investors and patients followed, culminating in a major Supreme Court decision that ruled Medtronic could not be held liable for a device that met the FDA’s toughest regulatory standards.
Earlier this year, Medtronic told doctors that lead failures may have factored into at least 13 deaths. About 260,000 Sprint Fidelis leads have been implanted in patients in the United States, with 143,000 still active. Leads can’t be easily removed, which is why Medtronic had advised patients to leave them in.
A report by UBS Investment Research said lead failures could accelerate over time, citing independent studies that predict failure rates could hit 30 percent by four years. Medtronic’s own data suggests a 3 percent failure rate at three years.
’Fidelis may cast a long shadow’ over the $5 billion ICD market, the report said.
In some ways, it’s not surprising Minnesota’s medical device community would be skeptical about a technology developed by a Californian startup. It really does upend the whole model of traditional ICDs. Up until now, medical device companies have focused on creating smaller, thinner leads that are easier to implant and maneuver.
But Sprint Fidelis has proved the limits to that technology. Which is why Cameron’s device cannot be so easily dismissed.
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Interesting article. Medtronic recently commented at both the HRS and Cardiostim meetings about their specific plans to work on a leadless cardiac pacemaker. The device would be placed directly in the right ventricle. It seems that they and others acknowledge that the lead has always been the weak link in the present approach to delivering pacemaker therapy. There's another California start-up, Nanostim that I've also heard is working on this concept. Eliminating the lead and the surgical pocket seems like a significant advance.
I have a Boston ICD. While it doesn't pace me, in the aftermath of a shock for VF (I had an SCD) it could be needed to help my heart keep going in the few minutes after the shock. I think I'll keep my ICD sensors and coils as close to my heart muscles as possible.
It's very important to note the disadvantages and limitations of this device. It cannot provide pacing or cardiac resynchronization therapy. It also requires more power to generate equivalent effectiveness and therefore is a much larger device with a shorter lifespan. I assure you that this technology has been evaluated by the big 3 and while a device of this design may find a niche in this market, it is certainly not an equivalent to much of what is already out there.
I think the article is factually right but gives the wrong impression. The goal of this device appears to be not targeted to take over the general ICD market, but rather provide an option for patients who do not need pacing and would be at risk with implanting a transvenous device. Cameron Health provides a breakthrough in how ICD is done, and we should recognize and build upon that breakthrough rather than shut it down. For example, what if leads could be removed all together? Or what if pacing could be done somehow subcutaneously. From Paul Stein, it should be noted that Boston Scientific is a huge funder of this technology.
Michele, thanks for reading. Good luck with your fiance's condition.
Tom I like your articles, and I often come to MedCity news to find out what is going on in the medical device industry, and industry that my company serves. This issue is personal though since my fiance has been told that he needs one of these devices to control his a-fib. And we have had a hard time getting info about the side effects of an ICD. Shocks to the heart do not sound pleasant. I am going to ask his doctor about Cameron's device. Thanks!
Paul, sounds like you're more upset about the headline than anything else. I'm sure Medtronic is not sweating bullets. But frankly, I think a little competitive hyperbole is good for our companies: they should always worry about disruptive technologies. Inflammatory? You betcha! Speaking of inflammatory, your observation that "the Fidelis shadow has simply gone away" demonstrates either remarkable arrogance or remarkable wishful thinking or both. Simply gone away? Try telling that to the hundreds of thousands of patients with leads that could still fail. Try telling that to Medtronic, which is still deadling with the fallout.
Thomas Lee should learn something about medical devices and the history of defibrillation before he jumps on the hype bandwagon, especially with such an inflammatory article title. First, the Cameron device cannot use low-voltage pacing therapies to treat tachycardias, the most prominent problem in patients, which is exactly what the original implantable defibrillator developed by Cardiac Pacemakers Inc. (CPI) could only do. When Medtronic came out with the pacemaker-cardioverter-defibrillator (PCD) after patents lapsed, CPI's market share dropped 50% almost overnight. This market dominance continued further by Medtronic, forcing CPI to change to PCD-like devices. This indicates that shock-only devices will always be a minority market. Second, devices were large in 1980 because there was 1980 technology to use. Devices are significantly smaller now because there has been three decades of technological progress. By 2010, Cameron should have benefitted from all of this development too, so if the Cameron device is relatively big, it will not get much smaller soon. However, we could give them thirty years to get it right. Third, any company's device's wiring can fail. Both Boston Scientific's and Medtronic's devices have shown this recently, in different ways. Indeed, a large portion of Medtronic's Fidelis problems occurred outside of the chest. Fourth, the longevity of St. Jude Medical's high voltage leads disproved Mr. Lee's assertion that there are absolute limits to the technology, and because of these successes, the Fidelis shadow has simply gone away. In conclusion, "the Minnesota’s medical device community" is not just "skeptical about a technology developed by a Californian start-up", they simply know better.