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First Patient in Japan Treated with Impella 5.5 with SmartAssist
Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Very Positive)
Tags
Rhea-AI Summary
Abiomed (NASDAQ: ABMD) reports significant advancements with its Impella 5.5 with SmartAssist heart pump, with over 5,000 patients treated globally. The first successful procedure in Japan was conducted at Osaka Police Hospital on an 82-year-old patient. The milestone procedure in the U.S. was performed by Emory University Hospital on a 41-year-old woman. Impella's design enhances minimally invasive surgical options, optimizing patient outcomes with a 74% survival rate to explant. The device is now utilized in over 350 centers in the U.S.
Positive
Over 5,000 patients treated globally with the Impella 5.5 with SmartAssist.
First successful procedure in Japan, expanding market reach.
Demonstrated 74% survival rate to explant in clinical studies.
Device approved for safety and efficacy by the FDA, enhancing credibility.
Negative
None.
5,000 Patients Treated Globally
DANVERS, Mass.--(BUSINESS WIRE)--
The versatility and innovation of Abiomed’s (NASDAQ: ABMD) Impella 5.5 with SmartAssist, a minimally-invasive forward flow heart pump, is leading to continued adoption of the game-changing technology by surgeons around the world. Today, Abiomed announces the first patient in Japan has been treated successfully with Impella 5.5 with SmartAssist. Additionally, the number of patients treated globally has surpassed 5,000.
Surgeons at Osaka Police Hospital view a fluoroscopy image showing Impella 5.5 with SmartAssist pumping in the patient’s heart during the first procedure in Japan. (Photo: Business Wire)
The first Impella 5.5 with SmartAssist procedure in Japan took place at Osaka Police Hospital when an 82-year-old man was treated for cardiogenic shock. “Our facility is proud to be the first in Japan to treat patients using Impella 5.5 with SmartAssist,” said Yoshiki Sawa, MD, PhD, director at Osaka Police Hospital. “We are excited to utilize this innovative technology and look forward to providing a minimally invasive surgical option for our acute heart failure patients.”
The milestone 5,000th procedure was performed by Tamer Attia, MD, at Emory University Hospital in Atlanta on a 41-year-old woman with cardiomyopathy. “Impella 5.5 with SmartAssist has completely changed how we are able to support our cardiogenic shock and cardiomyopathy patients,” said Mani Daneshmand, MD, chief of the section of thoracic transplant and mechanical circulatory support surgery at Emory University Hospital. “Given the safety and efficacy of Impella 5.5 with SmartAssist, Dr. Attia and his team are able to treat patients who otherwise would not have had other options for heart recovery.”
Impella 5.5 with SmartAssist is:
Minimally invasive, eliminating the need for a sternotomy or coring of the left ventricle;
Designed for heart surgeons, implanted via the axillary artery or the anterior aorta;
Forward flow, to provide the patient with coronary flow and renal perfusion;
Fully unloading, to reduce the heart’s oxygen demand and work; and
Equipped with SmartAssist, designed to provide weaning algorithms to optimize survival and native heart recovery.
Additionally, more than 90% of patients are securely monitored in the cloud via Impella Connect, giving providers access to Impella status data 24/7.
Impella 5.5 with SmartAssist, which was granted the highest level of approval for safety and efficacy by the U.S. Food and Drug Administration (FDA) in 2019, is now being used in more than 350 centers across the U.S. for indications that include AMI cardiogenic shock, cardiomyopathy and post-cardiotomy cardiogenic shock. Historically, the cardiogenic shock survival rate has been approximately 50%. Published in Innovations, a study of 200 patients treated with Impella 5.5 with SmartAssist at 42 medical centers in the United States demonstrates a 74% survival to explant, with 58% of those patients achieving native heart recovery.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support and oxygenation. Our products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit: www.abiomed.com.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are US FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, to reopen blocked coronary arteries.
Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are US FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.
FORWARD-LOOKING STATEMENTS
Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
United States Media:
Jenny Leary Associate Director, U.S. Communications +1 (978) 882-8491
jleary@abiomed.com
Japan Media:
Itsuki Shinohara Manager, Public Relations
+81-3-4540-5600
ishinohara@abiomed.com
Investor:
Todd Trapp Vice President and Chief Financial Officer
+1 (978) 646-1680
ttrapp@abiomed.com
Source: Abiomed, Inc.
FAQ
What is the significance of the 5,000th patient treated with Impella 5.5 with SmartAssist?
The 5,000th patient treated with Impella 5.5 with SmartAssist signifies the widespread adoption and effectiveness of the device, enhancing its market presence.
Where was the first Impella 5.5 procedure conducted in Japan?
The first Impella 5.5 procedure in Japan was conducted at Osaka Police Hospital.
What is the survival rate for patients treated with Impella 5.5?
Clinical studies show a 74% survival rate to explant for patients treated with Impella 5.5.
How many medical centers in the U.S. are using Impella 5.5?
Impella 5.5 is now used in over 350 medical centers across the U.S.
What conditions can Impella 5.5 treat?
Impella 5.5 can treat conditions such as AMI cardiogenic shock, cardiomyopathy, and post-cardiotomy cardiogenic shock.
