Federal regulators have approved the Watchman heart implant for a limited group of patients.
But that didn’t stop Boston Scientific from courting thousands of doctors and buying TV ads to promote it to a much wider population, creating a $2 billion juggernaut.
Despite all the setbacks, Boston Scientific will not stop pushing the Watchman.
The medical device giant has committed hundreds of millions to acquire the small heart implant. a decade ago, then endured a years-long debate within the Food and Drug Administration over whether to approve it.
When that approval finally came, for a limited group of patients, Boston Scientific was prepared with a plan for something much larger.
According to company executives, The Watchman had all the makings of a blockbuster.
It was a new type of treatment for millions of people suffering from atrial fibrillation, also known as A-fib, an irregular heartbeat that can feel like a chest full of angry butterflies. Even more dangerous, A-fib increases the risk of stroke by five times.
For generations, the best way to prevent strokes was to take a blood thinning pill every day, virtually forever, to prevent clots from forming. But these drugs come with their own risks, from very bloody razor cuts to internal bleeding after a bad fall.
The Watchman was designed to prevent strokes in a different way. The umbrella-shaped device, the size of a quarter, is intended to seal off a corner of the heart where many clots form, as if blocking a well.
Trading a lifetime of blood thinners for a single surgical procedure – that was the talk.
Then the Marlborough-based company decided to sell it.
The world headquarters of Boston Scientific. (Lane Turner/Globe Staff)
Immediately, so-called regional heart centers were established, including at a hospital in Manchester, New Hampshire, where the company gave deep discounts on heart machines, brought in a star technician from Europe to consult with him, and sent company representatives into the operating room to consult with him. advise surgeons.
In 2017, there was a Watchman specialist center near you – at least 200 nationwide.
There were consulting and other fees for doctors, over $30 million and counting.
In 2019, the company launched a national television ad campaign, a common tactic for prescription drugs but rare for a surgical device classified as high-risk. A “unique implant that reduces the risk of stroke and bleeding concerns – for life,” the ads promised.
The Watchman – an umbrella-shaped device made of metal and mesh – is typically placed in a patient’s heart after being threaded through a catheter. (Portland Press Herald)
So far, doctors have implanted more than 800,000 devices in patients around the world. In 2025 alone, sales of the device reached nearly $2 billion, up about 30% from the previous year — “clearly a gem for Boston Scientific,” as company CEO Mike Mahoney said on an investor call last year.
A gem indeed, at least for Boston Scientific’s bottom line. But there is only one complication: the scientific data is much less clear.
There is a growing gray area in the American health care system, where medicine and money do not mix well.
It’s a place where what’s good for patients and what’s good for business can sometimes conflict, in ways that don’t cross regulatory boundaries but still raise ethical questions.
Should a patient be encouraged to consider invasive surgery when simply taking a pill provides equally good or better results?
Enter the guard.
Boston Scientific has pushed its flagship heart implant to the edge of the gray zone, according to the Boston Globe Spotlight team’s analysis of clinical studies, regulatory documents and years of financial records and marketing data. The Globe also interviewed more than two dozen cardiologists, clinicians and researchers across the country who expressed growing concern about the device.
Doubts within the medical community have increased after recent clinical trials, which showed that Watchman is often no better, and in some cases worse, than a proven blood thinner.
And yet the company has ramped up its sales and marketing efforts to help strengthen demand for what many cardiologists consider unnecessary procedures.
“Many of us feel that sometimes it’s done inappropriately, that (providers) are too cavalier in their preparation for installing these devices,” said Dr. Gregory Marcus, a cardiologist at the University of California, San Francisco. “I do not think it is responsible for a medical practice to push for such a device in the vast majority of patients with fibrosis A.”
Cardiologist Dr. Gregory Marcus, working in his office on the Parnassus campus of the University of California, San Francisco. (Jakub Mosur for the Boston Globe)
A doctor who served on two early FDA panels said experts worry about so-called “drift,” when the target audience for a drug or device expands beyond its proven or intended use. He now thinks that’s exactly what’s happening.
Few people at high risk devices in recent history have been promoted as heavily as the Guardian. Over the past decade, Boston Scientific has paid doctors more than $30 million to publicize the product, teach colleagues how to use it and provide consultations. It is also invested at least another $23 million in TV ads targeting patients, according to an industry estimate.
And all this for a device placed in patients’ hearts “based on borderline evidence,” as cardiologist Dr. Petr Widimsky said in an editorial in the New England Journal of Medicine in March.
The long-running debate over the Watchman erupted in medical circles that month, when the prestigious journal published two studies and two editorials that led to serious questions about Boston Scientific’s efforts to put the device on par with blood thinners as a “first-line” treatment for fibrosis A.
A change in focus could increase the number of people potentially eligible for a Watchman position, from the current 5 million worldwide. to more than 20 million, according to an estimate by Boston Scientific.
In an interview, Boston Scientific’s global chief medical officer, Dr. Kenneth Stein, called Watchman a “proven alternative” to blood thinners, supported by clinical data.
Stein, a cardiologist, pointed out that 30 to 40 percent of people with fibrosis A cannot or do not want to take blood thinners. This group — which includes people with conditions that make them prone to bleeding, those who dislike the side effects of blood thinners, including bruising, as well as people who simply don’t like taking the medication — represents millions of people who don’t get medical help to reduce their risk of stroke.
“It’s a tragedy when people who could have avoided a stroke have a stroke because they are not protected,” Stein said. “They deserve to be informed of the alternatives and decide for themselves whether they want them. »
Boston Scientist don’t think the device “is grossly overused,” company spokesperson Chanel Hastings told the Globe. “We remain steadfast in our confidence in the Watchman device and the extensive clinical evidence supporting its safety, effectiveness and important role in reducing the risk of stroke in appropriate patients with atrial fibrillation.
But for others, the rise of THE Watchman tells a larger, more disturbing story about our healthcare system.
“The Watchman is emblematic of the flaws in how the medical business works,” Dr. Gregory Katz, cardiologist at NYU Langone Health. “We do a lot of things that may not be the right things for patients. »
The treatment of A-fib is one of the fastest growing areas of medicine.
More than 10 million Americans have been diagnosed with this condition, the most common arrhythmia. This is an expanding patient pool that presents opportunities.
One procedure on the rise is ablation, which uses sophisticated tools to disable faulty heart tissue and stop an irregular heartbeat. It costs about $50,000 in Massachusetts, where private insurers spend more on ablations than any other outpatient procedure. Nearly 10,000 ablations were performed here last year, according to the Massachusetts Health Policy Commission, triple the number compared to 2020.
Implementations of the Watchman and its distant competitor Amulet, for which Medicare pays about $25,000, have grown even faster — about seven times nationally in the past six years.
The device was invented by a small company in Minnesota called Atritech. Although early clinical trial results were encouraging, they were inconclusive, and the FDA declined to approve the Watchman when it was first evaluated in 2010.
A year later, Boston Scientific purchased Atritech for up to $375 million. As one of the world’s largest medical device manufacturers, now with 59,000 employees and $21 billion in annual revenue – the company was confident it had the expertise and resources to convince the agency.
But trouble awaits us.
As Boston Scientific pushed for approval in 2013, the FDA twice asked for more data on how Watchman patients have been doing well since the latest study results. When updated information came in the following year, agency officials felt uneasy.
The data “raises new questions about the effectiveness of the device,” they wrote.
The Watchman was designed to prevent ischemic strokes, a type caused by blood clots traveling from the heart to the brain. However, 13 of the 269 People in the study who received Watchman experienced this type of stroke, compared to one of 138 people taking the blood thinner warfarin. The rate among Watchman patients was nearly seven times higher.
To make sense of this discovery, The FDA took the unusual step of convening a third panel of experts to evaluate the safety and effectiveness of the device. Ultimately, in a close 6-5 vote, the panel recommended that the FDA approve…
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