Ventricular assist devices

HeartWare™ HVAD™ system

<p>Walking beside you because <b>patient care still matters</b>.</p>

Indications, Safety, and WarningsUrgent product updateMedtronic has stopped the distribution and sale of the HVAD™ system as of June 3, 2021, and has notified physicians to cease new implants of the Medtronic HVAD™ system and transition to an alternative commercial LVAD for all future implants. Prophylactic explant of the HVAD™ system is not recommended at this time.Information for patientsIndicationsThe HVAD™ system is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a bridge to cardiac transplantation (BTT), myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned.ContraindicationsThe HVAD™ system is contraindicated in patients who cannot tolerate anticoagulation therapy.
Warnings and precautionsProper usage and maintenance of the HVAD™ system is critical for the functioning of the device. Serious and life-threatening adverse events, including stroke, have been associated with use of this device. Blood pressure management may reduce the risk of stroke. Never disconnect from two power sources at the same time (batteries or power adapters) since this will stop the pump, which could lead to serious injury or death. At least one power source must be connected at all times. Always keep a spare controller and fully charged spare batteries available at all times in case of an emergency. Do not disconnect the driveline from the controller or the pump will stop. Avoid devices and conditions that may induce strong static discharges as this may cause the VAD to perform improperly or stop. Magnetic resonance imaging (MRI) could cause harm to the patient or could cause the pump to stop. The HVAD™ pump may cause interference with automatic implantable cardioverter-defibrillators (AICDs), which may lead to inappropriate shocks, arrhythmia, and death. Chest compressions may pose a risk due to pump location and position of the outflow graft on the aorta — use clinical judgment. If chest compressions have been administered, confirm function and positioning of HVAD™ Pump post-CPR.Potential complicationsImplantation of a VAD is an invasive procedure requiring general anesthesia and entry into the thoracic cavity. There are numerous known risks associated with this surgical procedure and the therapy including, but not limited to, death, stroke, neurological dysfunction, device malfunction, peripheral and device-related thromboembolic events, bleeding, right ventricular failure, infection, hemolysis, and sepsis.Refer to the instructions for use for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events prior to using this device.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.UC202602544 EN

Urgent product update

Medtronic has stopped the distribution and sale of the HVAD™ system as of June 3, 2021, and has notified physicians to cease new implants of the Medtronic HVAD™ system and transition to an alternative commercial LVAD for all future implants. Medtronic initiated this action in light of a growing body of observational clinical comparisons demonstrating a higher frequency of neurological adverse events, including stroke and mortality with the HVAD™ system as compared to other commercially available LVAD.

24-hour clinical support

An MCS hotline is available for questions or additional information around the HVAD system.

English: +1 888-494-6365

German: +49 2159 8149908

MCS customer service

Customer service hours: 7 a.m.–6 p.m. CT
+1 877-367-4823

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Clinician tools for HVAD™ patient management

The clinician tools for HVAD™ patient management are the newest addition to our Patient and Provider Support Program, developed to connect and equip the clinical community for long-term patient management.

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HVAD™ product education briefs

View information for clinicians on enhanced product or feature functionality.

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Patient and provider support program

There is nothing more important to Medtronic than the safety and well-being of patients. Although we have stopped distribution and sale of the HVAD™ system, we are committed to serving the needs of the patients currently implanted with the device and the clinicians who care for these patients.

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