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
Gemcorp and Fonds Souverain Malagasy Announce Strategic Partnership to Support Investment in Madagascar7.10.2026 10:00:00 CEST | Press release
Gemcorp and the Fonds Souverain Malagasy (“FSM”) signed a strategic partnership during the 81st United Nations General Assembly (“UNGA”) in New York, establishing a framework to support investment and the development of Madagascar’s strategic assets. Under the leadership of His Excellency Michael Randrianirina, President of the Republic of Madagascar and guided by his vision to “transform the potential and endowments of the country into tangible impacts for the people,” the partnership will support FSM and the Government of Madagascar in advancing the country’s growth and investment agenda. This includes a particular focus on unlocking the value of Madagascar’s mineral resources, alongside its broader assets across mining, energy and infrastructure. As part of this partnership, FSM and the Government of Madagascar will set the strategic direction and priorities, with Gemcorp supporting FSM in structuring projects, developing investment and financing solutions, and connecting projects w
High Awareness, Low Adoption: New Survey Reveals Nearly Half of Security Professionals Still Rely on Passwords7.10.2026 09:01:00 CEST | Press release
Global study from Yubico and Okta highlights a critical execution gap in enterprise security, shows how modern identity controls can eliminate password dependency. A new survey from Yubico (NASDAQ STOCKHOLM: YUBICO), the pioneer of phishing-resistant authentication and creator of the original passkey, the YubiKey, and Okta, Inc., reveals a significant gap between security knowledge and everyday practice. While security leaders overwhelmingly recognize phishing-resistant passkeys as more secure than passwords, nearly half still rely on vulnerable login methods in their daily work. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007969823/en/ Conducted by Talker Research, the annual 2026 Global State of Authentication* report surveyed nearly 2,000 cybersecurity and IT professionals across nine countries. The report highlights that cybersecurity's primary vulnerability is no longer a lack of education or awareness, but a stru
Wolters Kluwer brings AI-powered drafting directly into the Libra legal workspace7.10.2026 09:01:00 CEST | Press release
In addition to Libra’s existing Word Add-in, Drafting in Libra gives customers the flexibility to choose the drafting environment that best suits their workflow, while automatically applying their firm’s existing templates Wolters Kluwer Legal & Regulatory today announced the launch of Drafting, a major new capability within Libra by Wolters Kluwer, the company’s legal AI workspace. Drafting enables legal professionals to create, edit, review, and collaborate on Word documents directly within the workspace, reducing the need to switch between separate applications throughout the drafting process. Together with Libra's existing Word Add-in, which is already widely used by legal professionals today, the new capability provides customers with a second, fully integrated way to draft their documents. Depending on their preferences and workflow, they can either remain within the Microsoft Word environment or work end-to-end in the Libra legal AI workspace. At the core of Drafting is the Libr
ClaroNav Kolahi Inc. Announces EU MDR Certification for Navient Surgical Navigation System7.10.2026 09:00:00 CEST | Press release
ClaroNav Kolahi Inc. (CKI), a global developer and manufacturer of surgical navigation technologies, today announced that its Navient Surgical Navigation System has received certification under the European Union Medical Device Regulation, EU MDR. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007890668/en/ ClaroNav Kolahi Inc. Announces EU MDR Certification for Navient Surgical Navigation System The certification covers the Navient Image Guided Navigation System and its reusable surgical instruments, allowing CKI to continue offering Navient throughout the European Union under the EU MDR regulatory framework. “EU MDR certification is an important milestone for CKI and demonstrates our continued commitment to meeting the highest standards for safety, quality, and regulatory compliance,” said Ahmad Kolahi, CEO of CKI. Navient was previously certified under EU MDD and has received regulatory approvals including US FDA, Heal
Yapı Kredi Kripto Selects Integral to Power Digital Asset Trading Services in Türkiye7.10.2026 09:00:00 CEST | Press release
Integral's institutional-grade digital asset trading technology will support Yapı Kredi Kripto's regulated cryptocurrency offering as Türkiye's new digital asset framework comes into effect. Integral, a leading provider of currency technology, today announced that Yapı Kredi Kripto has selected Integral's digital asset trading technology, enabling the group to provide cryptocurrency services through its soon-to-launch regulated digital asset business. The partnership comes as Türkiye introduces a new regulatory framework for digital asset service providers, creating a regulated environment for financial institutions to expand their offering to customers seeking access to cryptocurrency markets. Yapı Kredi Kripto has implemented Integral's digital asset trading technology across pricing, liquidity and risk management, providing the infrastructure required to deliver a secure and efficient cryptocurrency trading experience to its customers. Integral's established presence in Türkiye was
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