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
Andersen Consulting udvider sit udbud af humankapital med tilføjelsen af Jakarta Consulting Group16.1.2026 21:09:00 CET | Pressemeddelelse
Andersen Consulting styrker sine kompetencer gennem en samarbejdsaftale med Jakarta Consulting Group (JCG), der er et rådgivningsfirma, som er kendt for sin ekspertise inden for organisatorisk transformation, humankapitalstrategi og ledelsesudvikling. Med hovedsæde i Indonesien har JCG rådgivet virksomheder inden for brancher som ejendom, minedrift og produktion gennem strategisk og kulturel transformation. Med kerneydelser, der omfatter virksomheds- og administrationsrådgivning, hr-rådgivning, vurdering samt virksomheds- og ledelsestræning, er virksomheden kendt for sin evne til at transformere virksomheder og ledere med agilitet, kulturel intelligens og handlingsorienterede løsninger. "Vi har altid ment, at bæredygtig transformation begynder med mennesker – når ledere udvikler sig, følger organisationer med," siger Patricia Susanto, CEO for Jakarta Consulting Group. "Ved at kombinere Andersen Consultings globale perspektiv med vores regionale indsigt kan vi tilbyde kunderne mere helh
ClickHouse Raises $400M Series D Led by Dragoneer to Accelerate Expansion Across Analytics and AI Infrastructure16.1.2026 15:30:00 CET | Press release
Company acquires Langfuse to enter LLM observability and introduces a native Postgres service to unify transactional and analytical workloads ClickHouse, a leader in real-time analytics, data warehousing, observability, and AI/ML, announced today the close of its Series D financing, raising $400 million. The round was led by Dragoneer Investment Group, with participation from Bessemer Venture Partners, GIC, Index Ventures, Khosla Ventures, Lightspeed Venture Partners, accounts advised by T. Rowe Price Associates, Inc., and WCM Investment Management. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260116008883/en/ ClickHouse Co-Founders (left to right): Yury Izrailevsky, Aaron Katz, Alexey Milovidov The financing follows a period of sustained, accelerating growth for ClickHouse. The company now serves more than 3,000 customers on its fully managed service, ClickHouse Cloud, with ARR growing more than 250 percent year over year
Qualcomm Announces Quarterly Cash Dividend16.1.2026 15:00:00 CET | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.89 per common share, payable on March 26, 2026, to stockholders of record at the close of business on March 5, 2026. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensing busine
Nominations open for The MIDORI Prize for Biodiversity 2026 by AEON Environmental Foundation and the Secretariat of the Convention on Biological Diversity16.1.2026 09:00:00 CET | Press release
The MIDORI Prize recognizes outstanding individual contributions to the conservation and sustainable use of biodiversityThe unique prize contributes to raising public awareness of the essential role biodiversity plays for human well-being and in addressing global challenges such as climate changeThe Award Ceremony and Award Winners Forum will be held on 27 August 2026 in Tokyo, Japan The call for nominations for The MIDORI Prize for Biodiversity 2026 is open from 2 February to 31 March 2026. Nominations are invited from members of the public through the AEON Environmental Foundation website at https://www.aeonkankyozaidan.or.jp/en/prize/. The Award Ceremony and Award Winners Forum of the 2026 edition of the Prize will be held on 27 August in Tokyo, Japan. These events will contribute to the global mobilization around COP 17 of the Convention on Biological Diversity (CBD), which will take place in Yerevan (Armenia) under the theme of “Taking action for Nature”. Co-organized by the AEON
Tigo Energy and Weco Certify MLPE-Inverter Compatibility to Simplify PV System Design16.1.2026 06:00:00 CET | Press release
Tigo MLPE technology and hybrid inverters of Italian manufacturer Weco are now certified to work together to enhance design flexibility, system performance, and seamless integration. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced the Company has signed a certificate of compatibility with Weco S.r.l., documenting the compatibility between Tigo Flex MLPE products and hybrid solar inverters from Weco. The certification covers certain single-phase and three-phase Weco products and members of the Tigo TS4-A and TS4-X product families, when properly designed and installed. Together, these products are designed to deliver high-quality, enhanced value through a system that generates and manages solar energy more efficiently and delivers the features residential energy customers demand. “The compatibility between our inverter solutions and Tigo optimizers represents a significant step forward for the
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