World’s first patients treated with Impella RP Flex with SmartAssist

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces that the world’s first three patients have been treated by Impella RP Flex with SmartAssist, Abiomed’s all-new heart pump for patients with right heart failure. Weaning from Impella Assist was successful for all three patients and two of them have already returned home with their original hearts. Patients were treated at Hackensack University Medical Center/Hackensack Meridian Health in Hackensack, New Jersey, and Kingwood Medical Center in Kingwood, TX.


1670284308 556 Worlds first patients treated with Impella RP Flex with SmartAssist

The Impella RP Flex is implanted percutaneously into the internal jugular vein (IJ), allowing patient mobility while assisted, and is designed for easy implantation using a flexible cannula advanced over a wire additional support guide. The pump includes SmartAssist dual-sensor technology with Impella Connect, allowing care providers to monitor the pump remotely from any internet-connected device and providing advanced metrics to aid in pump management and weaning. It is also compatible with a sodium bicarbonate purge to simplify the management of the patient’s anticoagulants.

“ The Impella RP Flex is an innovative technology that may allow patients with right heart failure to remain mobile while being supported,” said Mark Anderson, MD, chairman of the Department of Cardiac Surgery and Cardiothoracic Surgeon at Heart and Vascular Hospital at Hackensack University Medical Center/Hackensack Meridian Health, which led the medical team for the world’s first Impella RP Flex implant.

Dr. Anderson and colleague Yuriy Dudiy, MD, implanted the Impella RP Flex in a 71-year-old patient who was undergoing minimally invasive valve surgery. The patient received Impella RP Flex support for five days while his heart rested and recovered. The second case of Dr. Anderson’s Impella RP Flex implantation involves a 51-year-old cardiac arrest patient who received Impella support for four days following valve surgery.

“ Identifying and treating right ventricular failure at an early stage is important, and the Impella RP Flex will allow more patients to experience native cardiac recovery,” said Robert Salazar, MD, interventional cardiologist and director of cardiovascular research at Kingwood Medical Center. Dr. Salazar and colleague Marloe Prince, MD, implanted the Impella RP Flex after a thrombectomy procedure in a 75-year-old patient with a pulmonary embolism. The patient remained on life support for four days and is expected to be discharged from hospital within the next few days.

The Impella RP Flex is the latest version of the Impella RP heart pump. The Impella RP received Humanitarian Device Exemption (HDE) approval from the US Food and Drug Administration (FDA) in 2015, followed by Premarket Authorization (PMA) , its highest level of approval as declaring it safe and effective in 2017. October 2022the FDA granted the Impella RP Flex a PMA to treat acute right heart failure for up to 14 days, with the first patients treated in November 2022.

Also in October 2022, the FDA accepted and closed the Impella RP post-approval study, which had enrolled 110 patients at 29 study sites. The study represented real-world experience and identified best practice for early treatment of right heart failure. The data published in the Journal of Heart and Lung Transplantation show that patients who received Impella RP support within 48 hours of cardiogenic shock onset had a significantly higher survival rate than those who received late right heart support (72% vs. 14%, p< 0.001, Anderson et al.).

Impella RP Flex was launched in the United States through a controlled rollout to major cardiac rehabilitation centers.

ABOUT IMPELLA RP FLEX WITH SMARTASSIST

Impella RP Flex® with SmartAssist® is approved by the US FDA to provide temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation after implantation of a left ventricular assist device, myocardial infarction, heart transplant or open-heart surgery.

ABOUT IMPELLA RP WITH SMARTASSIST

Impella RP® with SmartAssist is approved by the US FDA for the treatment of right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplantation, or open heart surgery.

ABOUT ABIOMED

Based in Danvers, Massachusetts, USA, Abiomed (Nasdaq: ABMD) is a leading provider of circulatory support and oxygenation medical technologies. Our products are designed to allow the heart to rest and readjust by improving blood flow and/or to provide sufficient oxygenation for people with respiratory failure. For more information, please visit the website abiomed.com.

FORWARD-LOOKING STATEMENTS

All forward-looking statements are subject to risks and uncertainties such as those described in Abiomed’s periodic reports filed with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

The text of the press release resulting from a translation should in no way be considered official. The only authentic version of the press release is that of the press release in its original language. The translation will always have to be compared with the source text, which will set a precedent.

contacts

Media:
Jenny Leary

Associate Director, US Communications

+1 (978) 882-8491

jleary@abiomed.com

Investors:
Todd Trapp

Executive Vice President and Chief Financial Officer

+1 (978) 646-1680

ttrapp@abiomed.com

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World’s first patients treated with Impella RP Flex with SmartAssist


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