Press release
First 1,000 Patients Treated with Impella 5.5® with SmartAssist®, a Heart Pump Designed for Surgeons
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The Impella 5.5 with SmartAssist heart pump helped
In
The first 1,000 patients were treated primarily for cardiomyopathy, AMI cardiogenic shock, and post-cardiotomy cardiogenic shock, with an average duration of support of 14 days. (see figure 1) Uses of Impella 5.5 with SmartAssist include:
- Escalating a patient’s care to a higher level of cardiac support
- Providing bi-ventricular support, when used in combination with Impella RP
- Unloading the left ventricle of patients on ECMO, a combination therapy known as ECpella
In July, a study published in the
In August, the FDA granted Impella 5.5 with SmartAssist, and other left-side Impella heart pumps, an emergency use authorization (EUA) to treat certain patients with COVID-19 related complications who are undergoing ECMO treatment.
In October, the 2020 expert consensus from EACTS, ELSO, STS and AATS named Impella as a Class IIb recommendation as the primary or concomitant treatment option for post-cardiotomy cardiogenic shock with severe isolated left ventricular dysfunction. Impella is now recommended in 10 society clinical guidelines and consensus statements.
“We, as heart failure cardiologists and cardiac surgeons, are understanding the effectiveness of Impella 5.5 with SmartAssist as an unprecedented new option for cardiogenic shock patients as a bridge to recovery or bridge to next therapy,” said
One such patient is 64-year-old
Keith’s condition immediately began to improve, and he was able to walk around the hospital while on Impella support. The SmartAssist technology helped the physicians with patient management and assisted in weaning Keith off Impella after four days on support. Keith fully recovered and went home with his native heart. Today, Keith cares for his elderly father, enjoys time with his two children, and looks forward to traveling more with his wife.
“The Impella 5.5 with SmartAssist is a promising option for heart failure patients in cardiogenic shock,” said
“This heart pump is markedly improving the standard of care and enabling the management of higher risk cardiac surgery patients with a reduced left ventricular ejection fraction. It is incredible to have the opportunity to bring this advanced technology to our patients and see the improved outcomes firsthand,” said
Impella 5.5 with SmartAssist delivers peak flows of greater than 6 liters per minute. Benefits of the Impella 5.5 with SmartAssist include:
- Impella Connect, providing cloud-based remote monitoring in the COVID-19 era
- Ease of insertion, via the axillary artery or anterior aorta
- Designed for long-duration support, with patient ambulation, ceramic bearings and no pigtail
- Forward flow with maximum unloading, to provide end organ and coronary perfusion and allow the heart to rest
- Enables heart recovery, as a minimally invasive, weanable VAD
- Ease of patient management, can be intelligently positioned, weaned and managed with SmartAssist
It is available in the
ABOUT
Based in
ABOUT IMPELLA HEART PUMPS
The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are
Impella Left Ventricular (LV) Support Systems are also authorized for emergency use by HCPs in the hospital setting for providing temporary (≤ 4 days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist)
The Impella RP® is
The Impella RP is also authorized for emergency use by healthcare providers (HCPs) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID-19), including pulmonary embolism (PE). The Impella RP has not been cleared or approved for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19.
Impella Left Ventricular (LV) Support Systems are also authorized for emergency use by HCPs in the hospital setting for providing temporary (≤ 4 days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist)
FORWARD-LOOKING STATEMENTS
Any forward-looking statements are subject to risks and uncertainties such as those described in