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.
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