A faulty heart pump linked to 49 deaths and dozens of injuries worldwide remains in use despite a decision by the Food and Drug Administration to issue a warning about the risk of punching holes in the heart wall. is allowed to continue.

Tiny, candy-cane-wide impeller pumps are threaded through blood vessels to take over the work of the heart in patients undergoing complex procedures or in life-threatening conditions.

The FDA said the device’s manufacturer, Abiomed, should have notified the agency more than two years ago when it first posted updated information about the perforation risks on its website. The FDA added that such a notice would lead to broader public alerts for hospitals and physicians.

The warning is the latest in a series of concerns raised in recent years about the deadly side effects of cardiac devices, particularly those that take over the heart’s role of circulating blood. This is his third major FDA action against the Impella device in a year.

A series of studies suggests that the Impella heart device increases the risk of death in patients with unstable medical conditions. Meanwhile, the device maker has spent millions of dollars promoting the device and awarding consulting fees to cardiologists and grants to hospitals.

Since Abiomed was first notified of Impella complications in October 2021, the FDA has received 21 additional reports of heart wall tears associated with patient deaths, according to Abiomed spokeswoman Audra Harrison. It is said that

The FDA classified the warning sent last week as the most serious action taken against a product that could cause death or serious injury, not to mention removal from the market. This warning authorizes continued use of the device, along with updated risk information as required in the 243-page instruction manual that comes with the pump.

There are currently 66,000 impeller pumps in the United States and 26,000 similar units in Australia, Canada, France, India, and other countries.

The number of Impella-related injuries was considered alarming by some cardiologists. Some doctors said the role of pumps was already in question, citing a lack of high-quality research to establish whether they offer more benefit than harm. Some people also questioned whether a thick manual urging increased vigilance would prevent deaths.

“I think cardiologists are already being very cautious,” says Dr. Rita F. Redberg, a cardiologist and professor at the University of California, San Francisco. He is critical of the device. “Saying ‘be careful’ in response to 49 deaths does not address the issue at all.”

Johnson & Johnson MedTech acquired Abiomed in 2022. Dr. Seth D. Bilasarian, senior vice president of Abiomed, said in a statement that over 10 years, 300,000 Impella devices have been used in patients around the world. There have been no reported cases of heart wall perforation related to the product design or manufacturing, he said.

“We are proud that our technology is positively impacting patients facing life-threatening situations,” said Dr. Bilasarian.

Asked why Abiomed didn’t report the deadly risk sooner, Johnson & Johnson MedTech said it had taken extensive remediation steps. The company said lacerations in the heart wall are rare and a “known complication during invasive cardiac treatments.”

Since 2013, studies have shown that the device can sever blood vessels and cause severe bleeding.

According to FDA records, the company attributed the heart wall laceration to “operator action” and urged the use of the device in conjunction with imaging tools to avoid puncturing delicate heart tissue. The agency says the elderly, women and people with heart disease are especially at risk.

The pump is a temporary implant and is adjusted to the right or left heart chamber with different levels of pumping power. These are often used after a patient has a serious heart attack and the heart loses its ability to pump blood around the body. This device tends to be used in critically ill patients, and the risk of death for many patients is about 40 to 50 percent.

If the heart wall is torn by the device, “it’s an emergency surgery and it’s very rare that you can survive,” says Dr. Bobak Zian, a cardiologist and assistant professor of medicine at the University of California, Los Angeles.

The FDA’s new warning stems from a lengthy agency inspection of Abiomed’s Massachusetts headquarters last year that resulted in a warning letter in September. The FDA said its inspectors found numerous complaints that the agency should have reported, as well as an October 2021 bulletin outlining the risk of tearing.

A bulletin posted by the company on its website and app described heart wall perforation as a “rare complication” that was first noted in January 2018. Abiomed should have submitted a “report of correction or deletion.” FDA spokesperson Harrison said the agency was notified within 10 days of notification.

Abiomed said it included advice on how to use the device safely in physician training and sent a warning letter to doctors in late December.

Bilasarian said Abiomed counted all tears in the left ventricular wall that occurred during surgery, “regardless of whether they were directly related to patient outcome.”

The company issued two other serious warnings last year regarding Impeller pumps that the FDA deemed associated with a risk of serious injury or death.

The company warned in June that the pump could fail if it hits an artificial heart valve, killing four people and injuring 26 others. The company also addressed this issue by updating the device’s instructions, according to FDA records.

The Impella heart pump was first approved for use in 2008, but its use was controversial among cardiologists even before a spate of recent reports of problems. When one model of the device was approved by the FDA after additional review in 2015, a study sponsored by the company found that 73 percent, or 44, of 60 patients who met criteria for use survived one month after surgery. It turned out that it did.

By 2022, an FDA-mandated study showed similar results for 23 patients alive out of a group of 33. Of the other 70 patients followed in the same study, only 19 percent, or 13, were alive one month after using the Impella device.

The FDA supported the device, but urged doctors not to use it on patients suffering from organ failure or severe neurological damage.

Impella devices have increasingly replaced intra-aortic balloon pumps once used to pump blood into the blood vessels of critically ill patients, but a 2012 study called their effectiveness into question. It has since become less popular.

However, several studies have since concluded that Impella devices have higher mortality rates and far more bleeding complications than balloon pumps.

“When you look at the quality of evidence supporting this device, there is very little evidence for such a high-risk device,” said Dr. Nihar Desai, MD, associate chair of cardiovascular medicine at Yale School of Medicine. Author of his four studies on the Impella device.

The company reports the benefits of deploying the Impella device in non-emergency procedures, where doctors place stents or small metal tubes to open blood vessels near the heart. Other studies conducted in a single hospital without a comparison group have shown a survival benefit. Proponents of the device say it may be effective for certain patients.

Dr. Srihari S. Naidu, professor of medicine at New York Medical College, said the Impella device is valuable to have on hand. “We as physicians and communities need to make sure that we are approving the right equipment, that there is sufficient evidence to support its use, that we are using it in the areas where there is the most evidence, and that we are using it in the areas where there is the most evidence. “We’re charged with making sure that we’re developing the equipment. It’s the skillset to keep it safe,” he added.

Dr. Naidu said he has not received any funding from Abiomed.

Medicare will pay the hospital approximately $71,000 each time the device is used on a patient. According to Medicare data for 2022, the latest year available, Abiomed spends $6.3 million on consulting, food and research costs for doctors and grants of up to $50,000 to hospitals.

These fees were divided into approximately 24,000 cases and paid to approximately 9,500 U.S. cardiologists who performed the procedures. The company has been making similar payments since at least 2016, spending between $3.7 million and $7.5 million each year.

Johnson & Johnson MedTech acquired Abiomed, which primarily sold impeller equipment, in late 2022 for $16.6 billion. In a securities filing, Johnson & Johnson reported 2023 device sales of $1.3 billion, primarily due to one Impella model listed in the recent alert. This was due to the purchase of

When Dr. Desai of Yale University reported on the unusual bleeding rates associated with the Impella device, he said that because the costs are much higher than for balloon pumps, rigorous research into how to best treat patients is urgent. pointed out that it is necessary.

“You don’t want to think this is part of the story, but I think it’s naive to think that it can’t be part of the story,” he said.