Abbott Announces FDA Approval of Aspirin-Free Post-Operative Regimen for HeartMate 3™ LVAD

Aug 22, 2024 22:15 CST Updated 22:15

Abbott

Diagnostic and pharmaceutical product manufacturers

Abbott announcesHeartMate 3Approved by the FDA for postoperative use without the need for aspirin, previously also approved by CE and Health Canada.

Aspirin is a wonder drug. Since its creation in 1897, aspirin has gradually become a miraculous medication capable of treating "all sorts of diseases." As a non-steroidal anti-inflammatory drug, clinicians recognize its antipyretic, analgesic, and anti-inflammatory effects. It can be used to treat colds, fever, headaches, toothaches, joint pain, rheumatism, and more. It inhibits platelet aggregation and prevents thrombosis. It also effectively helps prevent cardiovascular and cerebrovascular diseases.

However, with the deepening understanding of clinical doctors onThrough in-depth research on aspirin, it has been found that although aspirin can prevent cardiovascular diseases, it may cause severe complications such as gastrointestinal and intracranial bleeding, ulcers, renal failure, blindness, and more. It can be said that the clinical benefits are far outweighed by the harm it causes.

To this end, Abbott launched a project onAspirin in the Prevention Study After Left Ventricular Assist Device Surgery (ARIES), Research has foundNot including aspirin in the anticoagulation regimen can effectively reduce bleeding.Complications and bleeding-related complications. AcceptHeartMate 3After treatment, discontinue use.Patients taking aspirin had nearly 40% fewer complications compared to those taking aspirin, without increasing the risk of thrombosis, and hospital stays were also significantly reduced.

Therefore, Abbott, according toARIES Clinical Study: A New Chapter BeginsHeartMate 3Postoperative Care Plan.

Expert Evaluation

"Aspirin and warfarin have traditionally been mandated for advanced heart failure patients with LVADs, but whether it causes excessive bleeding remains uncertain. The ARIES-HM3 trial removed aspirin from the medication regimen, providing critical data that challenges the assumption that patients with heart pumps must take aspirin daily. With this label change, physicians can avoid using aspirin in patients receiving the HeartMate 3 LVAD, a decision that is safe and can reduce bleeding and associated hospitalizations."

---Mandeep R. Mehra Brigham and Women’s Hospital

Executive Evaluation

"Removing aspirin from the HeartMate 3 regimen is a simple change, which means people with an Abbott LVAD can focus on what they enjoy and spend less time worrying and dealing with bleeding events. Through studies like the ARIES-HM3 trial, we continue to rewrite the book on managing patients with advanced heart failure and focus on delivering life-improving benefits for those who rely on our devices to survive."

---Keith Boettiger, Vice President of Heart Failure Business

HeartMate 3

HeartMate 3It is the most advanced left ventricular assist device currently on the market and the only product proven by large-scale clinical studies.HeartMate 3CanFor advanced heart failure requiring short-term or long-term mechanical circulatory supportPatient.

HeartMate 3Adopting advanced Full MagLev flow technology,Full MagLev Flow technology maintains gentle blood handling to minimize complications and adverse events related to blood compatibility. This is alsoCompared toHVADAndThe Main Reason Why HeartMate II is More Excellent

Full MagLev Flow Technology Advantages:

Fully suspended, self-defined rotor, no fluid dynamic or mechanical bearings required
A large and consistent blood flow path can reduce shear stress.
Intrinsic pulsation can reduce blood stasis and thrombosis.

HeartMate 3Demonstration

Abbott

Abbott, as a global leader in the healthcare industry, helps people live better at all stages of life. We bring cutting-edge technology to health and wellness, with leading products across diagnostics, medical devices, nutrition, and pharmaceuticals. Abbott's 109,000 employees worldwide empower people in more than 160 countries and regions to live life to the fullest.