My cardiologist stepped out of the exam room and returned with a medium-sized cardboard box that rattled as she walked. The contents: a few dozen watch-sized, titanium-encased implantable pacemakers of various shapes and thicknesses.
As of Jan. 2, 2014, a version of one of the many pacemakers I examined in that cardboard box has become a part of me, implanted under my right clavicle, with two wire leads snaked through two veins and into my heart.
My knowledge of the industry gave me the ability as a patient to ask questions that helped me choose a safe, reliable pacemaker and lead option. This led to a quick realization that true choices for most U.S. pacemaker patients remain limited, despite the marketing hype around innovation in the industry.
U.S. pacemaker patients get an odd combination of technological wizardry and clunkiness. The market also carries a built-in risk for complications--however small--that easily throws extra expense onto the overall healthcare system.
As I write this, I have had my initial pacemaker surgery, plus two additional procedures to address a wire that pulled out of its proper spot in my heart. Here's what I've learned, or been reminded of, so far:
How the big three dominate the global market for pacemakers
While a number of companies make sophisticated, reliable pacemakers for the global market, I was particularly interested in a product from a small international outfit. My doctor expressed that that option was viable but not practical. She and the hospital with which she is affiliated generally rely on pacemakers and leads from the three biggest cardiac device makers: Medtronic ($MDT), St. Jude Medical ($STJ) and Boston Scientific ($BSX).
Here's why: The Big Three have a near U.S. (and generally global) market dominance in pacemaker sales. That carries patient benefits, such as a much easier time getting my pacemaker checked, serviced and tweaked as I go through life and move to other cities, because local cardiologists and hospitals are more likely to have the technology and replacement parts to get the job done. Medtronic, St. Jude Medical and Boston Scientific are like the big three U.S. automakers were at their peak, and because of their market dominance, their size, accessibility and long-term relationships with insurers make them the go-to options for most U.S. doctors. Smaller rivals may be more innovative, but without the market penetration, they have long struggled to beat the Big Three.
A chest X-ray shows the author's pacemaker implanted behind his clavicle.
A look at the numbers bears this out. Consider that out of 30 global companies that make an implantable pacemaker, Medtronic, St. Jude Medical and Boston Scientific combined account for 90% of U.S. pacemaker approvals, according to EvaluateMedTech--including 510(k), PMAs, supplementary PMAs, and Humanitarian Device Exemptions. Of that number, Medtronic took up a nearly 40% share.
Globally, the same thing comes to pass for the top 5 pacemaker manufacturers in terms of sales. While 2013 pacer numbers continued to reflect global market stagnation, Medtronic booked nearly $1.9 billion in pacemaker sales in 2013, according to EvaluateMedTech data, remaining the world leader. Second-place St. Jude Medical produced nearly $1 billion in global pacemaker sales, followed by Boston Scientific, which booked $514 million. After that, Germany's Biotronik reported $397 million, and then Italy's Sorin came in with $219 million, with the remaining rivals dropping precipitously after that. For U.S. sales alone, the Big Three carry similar dominating roles.
Still, some choice remains within those limited options.
During the meeting with my cardiologist, I expressed concerns about the quality of some companies' pacemakers and leads in the wake of recent recalls. She told me not to worry because leads and pacers were generally interchangeable between companies, a feature that I didn't recall companies widely promoting. So I have a pacemaker from one of the big three companies and wire leads from another--both ranking high in terms of safety and (a lack of) recalls.
Leadless pacemakers: Hype versus reality
|St. Jude's Nanostim leadless pacemaker--Courtesy of St. Jude Medical|
St. Jude Medical recently placed its Nanostim leadless pacemaker into its first patient in the U.K., and the device has a CE mark. Both Medtronic and Boston Scientific are also trying to get their own leadless pacemakers into market and promise great advances in clinical trials to come.
Sure, St. Jude's milestone will help jump-start otherwise stagnant pacemaker sales at some point for the company overseas. Wireless pacemakers will also eventually lift St. Jude's rivals. But the reality is that U.S. consumers and many others around the world don't have access to such advances just yet, except through clinical trials. In the U.S. such a device is likely years away from gaining FDA approval.
That means that the rest of us with pacemaker implants must rely on the wire option, which comes with the risk of infection, lead failure and other complications. In my case, I faced a different complication--lead displacement--which leads me to my next point.
Existing pacemaker tech carries risks that add built-in extra costs to the healthcare system
Two weeks after my initial surgery, a follow-up exam revealed that one of the two wires inserted into my heart had moved about an inch out of its original spot. That meant the lead displacement had reduced the effectiveness of my pacemaker to a minimal level. This is a complication that I was warned about and could have resulted from something as simple as a sneeze. My cardiologist prescribed "lead repositioning surgery" to fix it--a procedure in which surgeons reopen the incision, take the pacemaker out and reposition the offending lead further into the heart.
The second surgery, three weeks to the day after the first procedure, went well. But after a night in the hospital, the lead dislodged again during a routine, early-morning X-ray. I endured a second lead-repositioning surgery later that morning, plus another night in the hospital before I could finally go home.
Most leads don't become dislodged after a procedure, but the fact that there was even a tiny risk builds an additional expense into the system that a wireless product just won't have. I am told that pacemakers are generally made for older patients, for whom lead repositioning isn't required as often because they simply don't move around as much or breathe as robustly as younger patients. This brings me to my final lesson learned.
I am not the target pacemaker audience
Companies may promote a pacemaker's versatility, and to some extent that is true. I am a nearly 45-year-old man, and my doctor assures me it will allow me to return to the same level of intense exercise and activity to which I was accustomed.
But make no mistake, pacemakers in their current form are built with older patients in mind. Consider the implantable wires, for example, which I am assured won't be adversely affected by intense exercise. But wires, as I have learned, can be displaced due to the most basic of movements, at least before scar tissue forms and anchors them more securely to the heart.
My particular pacemaker comes with a wireless transmitter that sends data to my doctor without having to go directly to her office. But it is designed to plug into a telephone landline and features overly large, nonthreatening operating system icons that are easy for a patient with poor eyesight to follow. The unit itself is also bulky, reminiscent of electronic devices common in the 1990s. It is simpler and easier for folks who may not be comfortable with current technology.
But that landline option! Few people under age 50 even have a landline at home anymore. Yes, we figured out how to plug it into our cable system, through our telephone. But patients today want mobility and to be able to send data through cell phones. In this case, the company offers a cell phone plug-in option through a third party, but there's an added monthly fee.
So went the lessons of my first few weeks with a pacemaker. I plan to follow the sector's advances and evolution closely in the years ahead, this time with interest that goes well beyond the professional. -- Mark Hollmer (email | Twitter)