MA-ABIOMED
26.4.2022 14:04:40 CEST | Business Wire | Press release
Abiomed (Nasdaq: ABMD) announces the first patient in the world has been successfully implanted with Impella Bridge-to-Recovery (BTR) as part of the heart pump’s U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS). The first implant was done by Duc Thinh Pham, MD, and Jane Wilcox, MD, at Northwestern Medicine Bluhm Cardiovascular Institute.
Impella BTR, a forward flow heart pump that is implanted via the axillary artery and sits in the left ventricle, can pump greater than six liters of blood per minute. It is smaller and less invasive than current LVADs and allows patients with chronic heart failure to have a longer-term minimally invasive heart pump option. Impella BTR’s design is intended to allow for heart recovery or heart remodeling with adjunctive therapies for patients with class III / IV heart failure. The vision of the Impella BTR development program is to provide a patient with home discharge and more than one year of full hemodynamic support.
“Bluhm Cardiovascular Institute at Northwestern Medicine is pleased to be the first in the world to implant Impella BTR as part of this important study,” said Dr. Wilcox, who is chief of heart failure treatment and recovery at Northwestern Medicine. “This novel technology could change the way we care for chronic heart failure patients by providing less invasive longer-term hemodynamic support with the goal of ultimately improving heart function in very sick patients.”
The intent of this study is to evaluate the safety of Impella BTR in patients who require left ventricular hemodynamic support, as well as the feasibility of supporting patients to recovery or their next therapy. The initial study will enroll 10 patients at five hospitals who will receive Impella BTR support for up to 28 days within a hospital setting. Patients will be securely monitored in the cloud via Impella Connect, giving providers access to Impella BTR status data 24/7. Once the study participant no longer requires hemodynamic support, the technology will be weaned and removed. Participants will be followed for 90 days.
“The first implant of Impella BTR is an important step toward our goal of improving patient care by providing a longer-term minimally invasive forward flow smart heart pump option with home discharge for patients with chronic heart failure,” said Michael Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “Overall, Abiomed is creating the innovation for the field of heart recovery and solving a healthcare crisis for this patient population with advanced research and technology.”
More detailed information about the study design can be found online at: https://clinicaltrials.gov/ct2/show/NCT05291884
Impella BTR is an investigational device, limited by federal law to investigational use only.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® 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.
Impella BTR ™ is an investigational device, limited by federal law to investigational use only.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc., is a leading provider of medical technology that provides 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: http://www.abiomed.com/ .
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220426005391/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
WHOOP Expands Commitment to Women's Health by Including One-Year Subscription of Natural Cycles° App in Membership4.8.2026 11:00:00 CEST | Press release
The integration gives eligible WHOOP members seamless access to the only FDA-cleared hormone-free birth control app, with the first year of Natural Cycles° included for those new to the app as part of their WHOOP membership. WHOOP, the human performance company, today announced an expansion of its women’s health offering through an integration with Natural Cycles° (NC°), the only FDA-cleared, hormone-free birth control app. WHOOP is offering a 12-month subscription to the NC° app to eligible new Natural Cycles users. Members with compatible WHOOP devices can now automatically share overnight skin temperature with the NC° app to enable personalized fertility insights and hormone-free birth control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804399367/en/ WHOOP Expands Commitment to Women's Health by Including One-Year Subscription of Natural Cycles° App in Membership The Natural Cycles app, a Class II medical device, u
Alphatax Makes Two Acquisitions to Strengthen Transfer Pricing Capabilities4.8.2026 10:00:00 CEST | Press release
Acquisitions Expand Transfer Pricing Offering and Support Long-Term Platform Strategy Alphatax, the global tax compliance software provider, has today announced the acquisitions of TP Accurate and Intra Pricing Solutions, expanding its transfer pricing capabilities and reinforcing its ambition to build the world's first tax operating system. The acquisitions strengthen Alphatax's transfer pricing portfolio with complementary capabilities across financial transactions and documentation. TP Accurate provides specialist software for intra-group financing arrangements, while Intra Pricing Solutions' flagship product, TPGenie, enables multinational organisations and advisors to produce transfer pricing documentation using intelligent automation and AI. Together, they expand Alphatax's ability to support the full transfer pricing lifecycle, helping customers manage compliance more efficiently while improving governance and reducing audit risk. They also represent another step towards Alphata
LabPMM® Launches Global KMT2A MRD Testing Service to Support Menin Inhibitor Development and Acute Leukemia Care4.8.2026 09:10:00 CEST | Press release
LabPMM®, an Invivoscribe® subsidiary, today announced the global availability of its new KMT2A measurable residual disease (MRD) testing service. The highly sensitive digital PCR service is available to healthcare providers, clinical researchers, and biopharmaceutical partners through LabPMM’s global laboratory network, with CAP/CLIA-accredited testing available in the U.S. The service addresses a growing need for accurate molecular monitoring in acute leukemias.1,2,3 KMT2A rearrangements (KMT2Ar) are oncogenic drivers in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).4 These rearrangements are present in about 80% of infant cases and 5-15% of childhood and adult leukemia cases.5 KMT2Ar leukemias are associated with chemotherapy resistance, high relapse rates, and poor clinical outcomes.5 The emergence of menin inhibitors is transforming the therapeutic landscape for patients with AML and ALL, particularly those with KMT2A-rearranged and NPM1-mutated disease.6 The
“HATSUNE MIKU LIGHTS TOKYO” Debuts on July 254.8.2026 09:00:00 CEST | Press release
Giant Hatsune Miku Returns to Light Up Tokyo’s Night! The Tokyo Metropolitan Government has been presenting year-round projection mapping displays on the Tokyo Metropolitan Government Building, using light and sound to showcase a wide range of artistic expressions as part of its efforts to create new nighttime tourism attractions in Tokyo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260802298570/en/ © Crypton Future Media, INC. On Saturday, July 25, "HATSUNE MIKU LIGHTS TOKYO", featuring the globally beloved virtual singer Hatsune Miku, held its first screening. The work brings the world of the popular song “M@GICAL☆CURE! LOVE ♥ SHOT!” to life across the entire façade of the Tokyo Metropolitan Government Building. Since its launch in February 2024, “TOKYO Night & Light” has welcomed visitors from Japan and around the world, with total attendance surpassing 1.55 million. As one of Tokyo’s emerging landmark attractions, the
Mosaic Therapeutics appoints Dr Allison Jeynes as Chair of the Board4.8.2026 09:00:00 CEST | Press release
Accomplished life sciences leader with a proven track record of driving successful development of novel therapeutics, joins Mosaic to guide its next phase of growthAllison brings three decades of drug development, board and executive leadership experience to support Mosaic’s transition towards a clinical-stage company Mosaic Therapeutics, Ltd, (‘Mosaic’, or ‘the Company’) an oncology therapeutics company developing novel, targeted drug combinations across a range of haematological and solid cancers, today announced the appointment of Dr Allison Jeynes as Chair of the Board to support its next phase of growth and advancement towards clinical development. Allison succeeds Dr Edward Hodgkin, who remains a Non-Executive Director of the Board. Allison is a UK-trained oncologist and highly-experienced life sciences leader, and brings over three decades of drug development and executive experience to Mosaic Therapeutics. As CEO of Avillion, a clinical development company, for the last 13 year
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom