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
The Data Center Marketplace Is Booming, Inaugural Data Center World Europe Unites Data Center and Energy Decision-Makers and Expertsin Vienna19.10.2026 12:00:00 CEST | Press release
Data Center World Europe 2027 took place October 13-15 at VIECON – Vienna Congress & Convention Center in Austria Last week, Data Center World Europe, where data centre developers, AI and cloud providers, energy and utility operators, and solution providers come together to drive the development of an AI-ready, sustainable future, united leading operators, technologists, cloud providers, hyperscalers and energy management innovators over three days at VIECON – Vienna Congress & Convention Center in Vienna, Austria. It was co-located with the leading global network infrastructure event Network X, where data centre developers, AI and cloud providers, energy and utility operators, and solution providers come together to drive the development of an AI-ready, sustainable future, united leading operators, technologists, cloud providers, hyperscalers and energy management innovators. Tara Gibb, Senior Director, Data Center World Europe said, “The conference tackled the industry’s most urgent
BeOne Medicines Highlights Rapidly Accelerating Solid Tumor Franchise at ESMO 202619.10.2026 12:00:00 CEST | Press release
New data from four priority programs, including the GPC3x4-1BB bispecific antibody, CEA targeting ADC, CDK4 inhibitor, and brain-penetrant PRMT5 inhibitor underscore the depth of BeOne’s solid tumor pipelineMultiple TEVIMBRA abstracts reinforce breadth of evidence across lung and gastrointestinal cancers, including data in combination with ZIIHERA in HER2+ gastroesophageal cancer BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that data from across its rapidly progressing solid tumor portfolio will be presented at the European Society for Medical Oncology (ESMO) Congress 2026 on October 23-27 in Madrid. Presentations will highlight an accelerating pipeline of differentiated targeted therapies, alongside a broad body of evidence for TEVIMBRA® (tislelizumab), including a late-breaking rapid oral presentation on TEVIMBRA in combination with ZIIHERA® (zanidatamab) in HER2+ gastroesophageal adenocarcinoma (GEA). Priority pipeline data
First and Only Ulcerative Colitis Treat-to-Target Trial Shows Treating to Disease Clearance vs. Symptomatic Remission with ENTYVIO® (vedolizumab) Prolongs Time to First Disease-Related Complication19.10.2026 11:30:00 CEST | Press release
More than half of ENTYVIO patients who met their assigned treatment target reached disease clearance (composite of corticosteroid-free symptomatic, endoscopic and histologic remission) at Week 16VERDICT is the first trial to provide macroscopic and microscopic evidence of intestinal tissue repair associated with disease clearance in largely bio-naïve patients treated with an advanced therapy Takeda (TSE:4502/NYSE:TAK) announced new data from VERDICT (NCT04259138), showing that treating adults with intravenous ENTYVIO® (vedolizumab) to achieve corticosteroid-free (CSF) disease clearance versus CSF symptomatic remission alone, resulted in a significantly longer time to first ulcerative colitis (UC)-related complication (hazard ratio 0.33 [95% confidence interval 0.17-0.67]; P=0.0014), reducing UC complication risk by nearly 70 percent. VERDICT, a Phase 4 ENTYVIO clinical trial, provides the first prospective, randomized evidence that disease clearance is an achievable and clinically rel
Boomi Acquires Elementary Data to Bring Trusted, Governed Data to the AI Era19.10.2026 11:00:00 CEST | Press release
Acquisition adds widely adopted data observability and reliability capabilities to the Boomi Enterprise Platform, giving enterprises the data quality and governance required to operationalize AI Boomi, the data activation company for AI, today announced it has acquired Elementary Data, a provider of the widely adopted data observability solution that powers every workflow and AI agent with reliable data. Following Lunar.dev, Elementary is Boomi’s latest acquisition, strengthening the Boomi Enterprise Platform with the observability, quality, governance, and discovery capabilities enterprises need to deliver trusted data for AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019376249/en/ Boomi Acquires Elementary Data to Bring Trusted, Governed Data to the AI Era Key TakeawaysWhat Boomi acquired. Elementary provides unified observability, quality, governance, and discovery. Founded in 2022, Elementary began as an open-sou
Reply Earns “NVIDIA Physical AI Specialization” for Production-Ready Robotics and Digital Twins19.10.2026 10:00:00 CEST | Press release
Reply [EXM, STAR: REY] is among the first NVIDIA partners in the world to achieve the “Physical AI Specialization” within the NVIDIA Partner Network (NPN), in recognition of its expertise in developing and deploying AI-driven robotics and digital twin solutions for real-world operating environments. The specialization was awarded following a technical assessment covering a customer implementation, solution architecture, certified OpenUSD expertise and Reply’s development roadmap. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019881053/en/ Reply is among the first NVIDIA partners in the world to achieve the “Physical AI Specialization” within the NVIDIA Partner Network (NPN), in recognition of its expertise in developing and deploying AI-driven robotics and digital twin solutions for real-world operating environments. Physical AI is becoming increasingly relevant in manufacturing, warehousing and logistics as companies mo
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