World’s first treatment with Impella RP Flex with SmartAssist

Impella RP Flex

Impella RP Flex with SmartAssist, Abiomed’s newest heart pump for people with right heart failure, is the first three-chamber heart pump in the world. We are happy to report that the patient of received treatment for All three patients were taken off of Impella support, and two of them have already been released after regaining cardiac function. Patients received care at Kingwood Medical Center in Kingwood, Texas, and Hackensack University Medical Center/Hackensack Meridian Health in Hackensack, New Jersey.

The internal jugular vein (IJ) is used to put Impella RP Flex percutaneously, allowing for patient mobility while providing support. A flexible cannula is introduced through an additional support guidewire for simple placement. It was planned. Healthcare practitioners may remotely monitor Impella from any internet-connected device thanks to SmartAssist’s dual-sensor technology and ImpellaConnect, which provide comprehensive metrics to help manage and stop Impella. Additionally, it works well with sodium bicarbonate purge solution, making it easier to regulate patient anticoagulation.

The medical team for the first Impella RP Flex treatment in the world was directed by Cardiac Surgeon Mark Anderson, M.D., Director of Cardiovascular Surgery, Cardiovascular Hospital, Hackensack University Medical Center/Hackensack Meridian Health. Impella RP Flex is a cutting-edge medical device that supports right heart failure patients while allowing for patient movement.

The Impella RP Flex was implanted in a 71-year-old patient having minimally invasive cardiac surgery for valvular disease by Anderson, MD, and colleague Yuriy Dudiy, MD. For five days, Impella RP Flex was used to support this patient as she rested and allowed her heart to heal. A 51-year-old patient who experienced a cardiac arrest and got Impella assistance for four days following valve surgery was Dr. Anderson’s second Impella RP Flex case.

“Early detection and treatment of right ventricular failure is critical. Impella RP Flex will help more patients regain normal heart function,” A 75-year-old patient was placed with Impella RP Flex after thrombectomy for pulmonary embolism. The patient has been on support for 4 days and will be discharged soon.

Robert Salazar, M.D., Interventional Cardiologist and Director of Cardiovascular Studies at Kingwood Medical Center

The most recent Impella RP version is Impella RP Flex. Impella RP was given Premarket Approval (PMA) by the U.S. Food and Drug Administration (FDA) in 2017 Did after first receiving Humanitarian Device Exemption (HDE) status in 2015. The FDA approved Impella RP Flex PMA in October 2022 for the treatment of acute right heart failure for a maximum of 14 days; the first patient started getting care in November 2022.

Furthermore, the FDA accepted and finished an Impella RP post-approval study in October 2022 that enrolled 110 patients at 29 research locations. The study determined the optimal techniques for the quick treatment of right heart failure based on empirical evidence. Patients who received Impella RP support within 48 hours of the onset of cardiogenic shock fared better than those who got right heart failure support later, according to findings published in the Journal of Heart and Lung Transplantation. revealed to be noticeably higher.

In the United States, prominent medical facilities for cardiac rehabilitation have a limited deployment of Impella RP Flex. Patients with a body surface area of 1.5 m2 or more who have acute right heart failure or compromised heart function following LVAD implantation, myocardial infarction, heart transplantation, or open heart surgery can receive temporary support from Impella RP Flex® with SmartAssist® for up to 14 days. Its application in targeted right ventricular assistance has been authorised by the US FDA.

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