MA-ABIOMED
Abiomed (NASDAQ: ABMD) announces the achievement of two milestones in the development of small bore access for the Impella heart pump. The Impella ECP heart pump has completed the first stage in its U.S. Food and Drug Administration (FDA) early feasibility study (EFS) and the FDA has granted 510(k) clearance to the Impella XR sheath.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201215005395/en/
The Impella XR sheath is a low-profile sheath that expands and recoils, allowing for small bore access and closure with the Impella 2.5 heart pump. It inserts at 10 French (Fr) and the flexible, nitinol braids momentarily expand during Impella delivery then recoil, simplifying access for complex interventions. The Impella XR sheath is intended to produce less trauma at the arterial access site compared to large bore sheaths.
The Impella XR sheath has been studied in patients outside of the United States on multiple occasions. The first patient in the U.S. is expected during Q4 of fiscal year 2021.
Additionally, Abiomed has successfully completed the first stage of the EFS of Impella ECP by enrolling and treating five patients. Impella ECP is the world’s smallest heart pump. It measures 9 Fr in diameter upon insertion and removal from the body. Once in the body, it expands to support the heart’s pumping function, providing peak flows greater than 3.5 L/min.
The prospective, multi-center, non-randomized EFS is designed to allow Abiomed, study investigators, and the FDA to make qualitative assessments about the safety and feasibility of Impella ECP use in high-risk percutaneous coronary intervention (PCI) patients. Abiomed will now submit data to the FDA and request to move to a second stage of the study with expanded enrollment.
“These milestones are important steps toward the fulfillment of Abiomed’s vision of creating an innovative portfolio of products that are smaller, smarter and more connected,” said Chuck Simonton, MD, Abiomed’s chief medical officer. “Design innovations like Impella ECP and Impella XR sheath will allow for a smaller access site with Impella, which will continue to drive better patient care and outcomes.”
Impella ECP is available for investigational use only and is not approved for use outside of clinical studies.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com .
ABOUT IMPELLA XR SHEATH
The Impella XR Sheath set is intended for use for the percutaneous introduction of the Impella 2.5 Catheter and ancillary devices.
ABOUT IMPELLA ECP
CAUTION: Impella ECP is an investigational device, limited by federal law to investigational use only.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are U.S. 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.
The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are U.S. 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
This press release contains forward-looking statements. 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/20201215005395/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
CyberArk Named a Leader in IDC MarketScape: Worldwide Integrated Solutions for Identity Security 202519.12.2025 17:00:00 CET | Press release
Unified platform uses AI and automation to accelerate time-intensive workflows, streamline operations and improve threat detectionEnables CISOs to consolidate cybersecurity stack, optimizing total cost of ownership CyberArk (NASDAQ: CYBR), the global leader in identity security, today announced that it has been recognized as a Leader in the IDC MarketScape: Worldwide Integrated Solutions for Identity Security 2025 Vendor Assessment. CyberArk extends dynamic privilege controls across all identity types with its unified platform, enabling organizations to improve efficiencies and streamline security operations. This IDC MarketScape report notes, “More change has occurred in the identity security marketplace in the past two years than in almost a decade. Vendors are entering a new phase defined by the emergence of intelligence technologies, none of which are specifically defined by any industry standards. Though different by design, the new adjacent IAM offerings are largely focused on im
New York Liberty and Ant International’s Alipay+ Announce Multiyear Partnership Focused on Empowerment, Sustainability and Youth Development19.12.2025 14:30:00 CET | Press release
Ant International’s Alipay+ Named an Official Sponsor and Innovation Partner for Sustainability of the Team The New York Liberty and Ant International’s Alipay+, a leading cross-border fintech services platform based in Singapore, today announced a multiyear partnership, making Alipay+ an Official Sponsor and Innovation Partner for Sustainability of the New York Liberty. Through this partnership, Alipay+ and the Liberty will jointly support community programs designed to advance community empowerment, environmental sustainability and youth development across New York City. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251219678825/en/ Peng Yang, CEO, Ant International and Clara Wu Tsai, Vice Chair, Brooklyn Sports and Entertainment; Governor, New York Liberty “Our partnership with Alipay+ goes beyond the game,” said Keia Clarke, Chief Executive Officer, New York Liberty. “Together, we are investing in the future of New York
Parse Biosciences and Codebreaker Labs Partner to Apply Whole Transcriptome Single Cell Profiling and Causal Genomics at Scale19.12.2025 14:00:00 CET | Press release
Collaboration pairs robust synthetic biology platform with massive scale single cell sequencing to overcome long-standing challenges in variant mapping Parse Biosciences, the leading provider of scalable and accessible single cell sequencing solutions, today announced a collaboration with Codebreaker Labs to develop and validate a breakthrough platform capable of testing thousands of genetic variants in parallel and measuring their effects at single cell resolution. By combining Codebreaker’s synthetic biology platform and variant engineering capabilities with the scale and accessibility of Parse’s Evercode™ technology, the collaboration aims to generate the causal data increasingly sought by AI developers, drug discovery teams, and clinical researchers. Today’s genomic studies rely heavily on observational data, or variants that appear in large populations. But rare and private variants, often only seen in one individual or family, are nearly impossible to study this way because too f
Cinemo Launches Cinemo ICO™, Accelerating the AI-Driven Intelligent Cockpit19.12.2025 11:00:00 CET | Press release
The future of in-car intelligence, delivered today for hyper-personalized, safer, smarter, and more exceptional journeys Cinemo, a global leader and highly innovative one-stop-shop provider for fully integrated digital media products announces today the launch of its next-generation, AI-powered cockpit solutions - Cinemo ICO™. By bringing agentic AI, Cinemo unlocks a truly intelligent cockpit - connecting vehicles, drivers, passengers, and their digital ecosystems into one seamless, personal and context-aware flow. The first product launched within the Cinemo ICO™ portfolio is Cinemo ICO™ MediaMind, enabling advanced intelligent media discovery. It combines the latest agentic AI technology with Cinemo’s core expertise of providing automotive-grade media management, helping users effortlessly discover the right content for every ride - perfectly matched to their taste, context, and environment. With Cinemo ICO™ MediaMind, the digital media experience evolves: using cutting-edge large la
Cyviz Awarded Two Classified NATO Defense Contracts19.12.2025 08:00:00 CET | Press release
Norwegian technology and platform company Cyviz AS has been awarded two classified defense contracts by major European NATO-partner nations to deliver a fully mobile, containerised Command & Control (C2) capability, strengthening Europe’s operational readiness in high-threat and expeditionary environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251218625485/en/ Image from a previous military exercise where Cyviz demonstrated a mobile command center solution. The contracts cover the design, integration, and delivery of secure, deployable operations centres engineered to NATO security standards, enabling military and security forces to establish full theatre-class command capability wherever operations require. Due to the sensitive nature of the missions, contract value and customer identities remain undisclosed. From Demonstrated Readiness to Operational Deployment The awards follow growing interest among European def
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