Abbott Implements Corrective Action For Heartmate 3 Heart Pump
Abbott previously communicated safety alert related to potential outflow graft twisting to physicians on April 5, 2018.
Abbott is communicating to physicians about a field corrective action related to the HeartMate 3 Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.
No devices are being recalled from patients or hospitals as a result of the corrective action, and the recommendations made by Abbott remain in place for physicians managing patients implanted with HeartMate 3.
Abbott is currently aware of 32 reports of outflow graft twisting in 4,467 HeartMate 3 devices worldwide (incidence rate of 0.72%), including reports of low blood flow, clotting (known as thrombus), and three reported deaths that could be associated with outflow graft twisting. As a result, Abbott has contacted physicians managing patients implanted with a HeartMate 3 LVAD in the event their patients report persistent low flow alarms that could indicate outflow graft twisting. Twisting of the outflow graft can occur at any point after implant.
In patients living with an LVAD, low flow alarms can often indicate unrelated conditions such as hypertension. For patients who experience a persistent low flow alarm after such causes have been ruled out, a computed tomography (CT) scan can help detect any possible outflow graft twisting. In addition, physicians managing patients that exhibit a persistent low flow alarm should determine patient care recommendations based on each unique clinical case.
Abbott has also alerted implanting physicians that as stated in the device's instructions for use (IFU), properly hand tightening the screw ring at the time of implant may reduce the chance of outflow graft twisting. Abbott has proactively contacted all physicians who treat patients impacted by this safety alert and will continue to assess current reports of outflow graft twisting to further provide physicians with patient care recommendations.
Advances in heart technology are helping people lead longer lives without a transplant.
Originally Published by Abbott.
In a strange way, getting robbed at gunpoint saved Tyrone Morris's life.
The scare eventually led to the discovery that Morris was living with congestive heart failure. Morris was just 38 years old, and his doctors were telling him that he had six months to live.
But thanks to three innovative pieces of heart technology from Abbott, Morris has been given a second — and even a third — chance at life.
This is his story.
A shocking diagnosis
On Sept. 14, 2011, Morris was working in the Milwaukee retail store he managed when two men entered the store around closing time. One intruder locked the doors; the other put a 9 mm pistol to Morris's head and demanded the money in the safe. His heart started racing — and didn't stop, even after the safe opened and the robbers left.
"I felt my heart drop in that moment," Morris said. "My heart just stopped working."
After that day, Morris says, his heart just felt worse and worse. About a year after the robbery, Morris was playing basketball when he noticed that he was having trouble getting up and down the court. This wasn't like him: He played college basketball at Crowley's Ridge College in Arkansas, and grew up working on a farm in rural Missouri.
Finally, Morris went to see his family doctor.
"She told me, 'Tyrone, we're taking you to the hospital,'" he said.
Morris refused to go. He went home. But his doctor called him repeatedly and urged him into going to the emergency room. Once Morris arrived at the ER, doctors almost immediately wheeled him back for surgery.
The diagnosis: congestive heart failure. Morris needed a pacemaker. He was just 38 years old — far too young for such a severe diagnosis, he thought.
"When I was first diagnosed, I didn't believe it," he said. "I never believed it until I got really sick with it."
Life-saving heart technology
Morris didn't have time to be sick.
He had a family to raise.
He had a restaurant, Big Country's Barbecue, to run.
He had his weekly bowling league — the sport he picked up when his heart problems prevented him from playing basketball.
Morris took his medications and visited his doctor regularly. But he was still leading a busy life, sometimes spending 14-hour days at his restaurant. About a year after his pacemaker was implanted, doctors discovered that his heart was retaining fluid — a dangerous complication for someone with congestive heart failure.
Morris's doctors recommended the CardioMEMS™ HF System. The heart failure monitoring system allows Morris's doctors to keep a close watch on him, wherever he is. Once a day, Morris lies on a pillow that measures his heart function, and the system wirelessly transmits those measurements to his care team.
"The CardioMEMS is excellent," Morris said. "It lets them know if my fluid is too high. It was a simple procedure."
But even with the pacemaker and CardioMEMS, Morris's heart kept getting worse. By 2014, Morris was unable to climb his stairs at home to bring in groceries. His heart was running out of time, his doctors said. He was going to need a new one.
When he was cleared for the transplant list, his doctors implanted Abbott's HeartMate 3™ left ventricular assist device (LVAD) — more commonly known as a heart pump — as a bridge-to-transplant therapy. The HeartMate 3 LVAD takes over the pumping function of your heart and can prolong the lives of those waiting for a transplant. It is also an option for those not eligible for a new heart.
But Morris didn't want a heart pump that would interfere with his life. So he asked for one small concession. Normally, the LVAD's wires come out of the right side of the body.
"I told my doctors I need them to come out my left side so I can continue to bowl," Morris said. "They made it work for me, and a week after I recovered and started bowling again, I bowled a perfect 300 game."
A stronger heart, a new outlook
With three heart technology devices keeping him alive, Morris is thankful for every day.
"I'm very thankful, very grateful," he said. "The changes that I've made, the technology, it gave me life, it gave me breath. It made me relive my life."
Morris regularly talks to congestive heart failure patients at the same hospital where he received treatment. He warns people not to ignore their diagnoses. He spent too much time denying his as his heart weakened, he says, and he encourages others not to make the same mistake.
"I tell everybody, don't take it for granted," he said. "Don't throw your diagnosis in the trash. It is real. It is serious. And if you catch it early, you can get the proper help."
He's often asked about how he's recovering from HeartMate 3 surgery, which can take months. Morris says that everything is what you make of it, and that it helps to have a strong support system — and a sense of humor.
"I crack jokes," he said. "I have fun, even when I'm down. I always tell myself every day is going to be a good day, especially having my wife wait on me hand and foot during recovery. We cracked jokes and made the best out of it."
The Food and Drug Administration (FDA) recently approved the HeartMate 3 as a destination therapy, which gives hope to people who are waiting for a transplant, such as Morris, as well as people who aren't eligible for one.
"I want a heart transplant, but if I had to live my life with the pump, I'd still be happy," he said. "I'd still do what I'm doing."
Thanks to his three Abbott heart devices, Morris is able to run his restaurant — where he's committed to serving all his food with no added salt. He's still shooting jumpers and bowling, still knocking down about 226 pins each game.
"I'm living the dream," he said. "Don't wake me up, either. Let me live."
Acquisition to further bolster Abbott's leading position in therapies for mitral valve disease, the most common type of heart valve ailment.
Abbott has announced that it has exercised its option to purchase Cephea Valve Technologies, Inc., a privately held medical device company developing a less-invasive heart valve replacement technology for people with mitral valve disease. Financial terms were not disclosed. Abbott provided capital and secured an option to purchase Cephea in 2015.
Abbott CFO highlights promising product pipeline and sustainable growth at key investor conference.
The need for life-saving blood can increase during the winter months, right when donations lag.
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At the height of the AIDS crisis in the 1980s, it was hard to imagine ending the AIDS epidemic.
Originally Published by Abbott.
As we approach the 30th anniversary of World AIDS Day, on December 1, we celebrate the tremendous progress made, and focus on working together to banish this epidemic to the history books.
Shooting for the Goal
While there is not a cure for HIV, we have made significant progress in testing and treating the virus, plus monitoring how people are responding to treatment – moving us closer to ending the epidemic. Today, three out of four people living with HIV know their status, a vital first step to getting treatment. And thanks to sustained access to antiretroviral therapy (ART), people with HIV are living longer and healthier lives.
As we work together to continue the fight against this global epidemic, goals have been set to reach specific targets so that AIDS is no longer a threat to our public health. To meet these targets, experts from the Joint United Nations Program on HIV/AIDS (UNAIDS) established the 90-90-90 plan to step up the HIV response so that by 2020:
- 90 percent of all people living with HIV will know their HIV status
- 90 percent of all people with diagnosed HIV infection will receive sustained ART
- 90 percent of all people receiving ART will have viral suppression
To make these goals a reality, the global health community must accelerate efforts for people to get tested, putting outreach programs in place that meet the needs in different parts of the world.
Testing is Key
For more than 30 years, Abbott has helped in the fight against HIV and AIDS. We're especially proud of our scientists who worked nonstop to develop the first HIV blood test, approved by the U.S. FDA in 1985, and of our team of Virus Hunters who relentlessly search the globe for signs of new strains of the virus.
Abbott's broad range of tests span the entire continuum of care for people at risk for HIV or living with the virus whether they are getting treatment at a public health clinic in Chicago or living in a remote village in Uganda. Abbott's tests are also used to screen more than 60 percent of the world's blood supply, helping keep it safe from infectious diseases.
While significant progress has been made, one challenge in reaching the 90-90-90 goals is making testing technology accessible to everyone, including people living in remote areas. Outside of the U.S., Abbott is helping address this issue with the collection of a few drops of dried blood on a special paper. These samples can be transported without immediate refrigeration for testing, making it possible for clinicians to monitor their patients' HIV treatment response.
An additional gap that needs to be addressed is diagnosing HIV in infants, for whom time is of the essence because nearly half of HIV-positive babies who don't receive timely treatment die before they reach the age of two. Outside of the U.S., Abbott is tackling this challenge by providing an early infant diagnosis test that offers same-day results at the point of care. Mothers often travel many miles to bring their babies for a doctor's visit, so being able to provide same-visit results enables faster access to HIV treatment.
We Could Make It Happen
No one organization can end the AIDS epidemic on its own. Over the years, Abbott has established several partnerships to increase access to testing to key populations.
The global health community has the tools and technology to help create a future in which AIDS is no longer a threat to our public health. But it's going to take all of us working together, using all the tools at our disposal, to do so. On World AIDS Day and every day, let's do our part to put an end to this epidemic. Talk to your doctor and encourage others to get tested for HIV.