Two Milestones Achieved Toward Small Bore Access with Impella
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 inserts at 10 Fr, momentarily expands during Impella delivery, then recoils. (Photo: Business Wire)
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.
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.
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.
Vice President and Chief Financial Officer
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
SSi Canada Partners with SES Networks to Deliver New Satellite Capacity into Northern Canada18.1.2021 17:40:00 CET | Press release
Vital new satellite capacity will be delivered to Canada’s north, including all 25 communities of Nunavut, following a partnership signed between SSi Canada, the developer-operator of QINIQ broadband and SSi Mobile services in Nunavut, and SES Networks, the leader in global content connectivity solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210118005410/en/ SSi Canada Partners with SES Networks to Deliver New Satellite Capacity into Northern Canada (Photo: Business Wire) This partnership comes at a critical time for Nunavut, with the COVID-19 crisis having led to an unprecedented need for reliable internet and mobile communications services as Nunavummiut move increasingly to study, work, and shop online and at home. With growing demand for QINIQ broadband and SSi Mobile services, all 25 communities in Nunavut - and elsewhere in Northern Canada - will benefit from SSi Canada’s multi-year agreement with SES Network
Cloud Contradiction: Despite Security Driving Cloud Adoption, Aptum Study Reveals It’s also the Main Barrier to Cloud Transformation18.1.2021 15:00:00 CET | Press release
While 91% of organizations were successful in increasing security as a result of adopting cloud services, it remains a top concern for many. This finding comes from part two of the four-part Cloud Impact Study from Aptum, the global hybrid multi-cloud managed service provider. The report, titled The Security and Compliance Barricade, identifies common security, compliance and governance challenges impacting organizations undergoing cloud transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210118005035/en/ Aptum Cloud Impact Study Pt 2.: The Security and Compliance Barricade (Graphic: Business Wire) The independent research reveals that more than half of survey respondents (51%) see security as the main driver behind cloud adoption. However, 38% cite security and data protection as the primary barrier to cloud transformation. Security and compliance play a critical role Part one of the Cloud Impact Study, Bridging
EG Group Selects PDI to Bring Contactless Payments to its North American Sites18.1.2021 13:00:00 CET | Press release
PDI (www.pdisoftware.com), a global provider of enterprise software solutions to convenience retailers and petroleum wholesalers, announced it has reached an agreement with EG Group to expand the use of PDI Payments to nearly 1,700 sites across North America. PDI added payments capabilities to its Marketing Cloud Solutions offering last year after acquiring ZipLine, the industry leader for ACH payment and provider of mobile payment technology. The PDI Payments platform currently powers EG Group’s SmartPay Rewards. The rewards program originated with Cumberland Farms—one of several U.S.-based convenience store brands EG Group acquired in recent years—and will soon be rolled out to EG Group’s remaining stores across North America. Customers can download the free app and enjoy a contactless payment experience, whether making purchases in the store or at the pump. PDI will provide the technology to support customer enrollment in SmartPay and deliver ongoing customer service for reward memb
Argo Blockchain PLC announces £22.4 Million Private Placement with Institutional Investors and Mining Capacity Expansion18.1.2021 09:46:00 CET | Press release
Argo, the leading cryptocurrency miner based in the UK (LSE:ARB), is pleased to announce that it has entered into a securities purchase agreement for a private placement of its ordinary shares ("Ordinary Shares") to certain institutional investors for gross proceeds of GBP £22.4 million (the "Private Placement"). Pursuant to the Private Placement, the Company will issue 28 million Ordinary Shares (the “Placement Shares”) at a purchase price of GBP £0.80 per Ordinary Share. The Private Placement is limited to those certain institutional investors that have already subscribed and this announcement should not be considered an offer or solicitation to purchase or subscribe for securities in the United States. H.C. Wainwright & Co. is acting as the exclusive placement agent for the Private Placement. The net proceeds of the Private Placement will be used by the Company for working capital and general corporate purposes, including the expansion of the Company’s mining capacity in Q1 and Q2 o
Reply Signs an Agreement with AWS to Develop Industry Solutions18.1.2021 09:30:00 CET | Press release
Reply, specialized on new communications channels and digital media, announces today it has signed a Strategic Collaboration Agreement (SCA) with Amazon Web Services (AWS) to develop industry solutions for Financial Services, Manufacturing, Automotive, Retail, Energy, and Telco customers. Through this SCA, the Reply Group of companies dedicated to AWS – Comsysto Reply, Data Reply, Sense Reply, and Storm Reply – will work with organizations of virtually all sizes and allow them to innovate faster and deliver consistent improvements on their business processes using advanced and secure AWS technologies. Reply’s companies dedicated to AWS will offer solutions for highly regulated Financial Services customers, providing them with strategic advisory and security-related consultancy, practices, and frameworks to modernize legacy platforms and solutions designed to address fraud and financial-crime use cases. They will also provide Industrial and Manufacturing customers with the tools they ne
L&T Technology Services Rated as Global Pure-Play ER&D Services Leader by Zinnov18.1.2021 09:00:00 CET | Press release
L&T Technology Services Limited (BSE: 540115, NSE: LTTS), a leading global pure-play engineering services company, today announced that it has been rated as a ‘Leader’ in new technologies critical for products and services transformation and also placed in the Leadership Zone across major ER&D Services’ sectors in the Zinnov Zones 2020 ER&D Services study for the fourth consecutive year. LTTS continued to hold the top leadership position in the pure play ER&D Services category in the Zinnov Zones assessments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210118005070/en/ LTTS rated as a Global Leader in ER&D Services in Zinnov Zones 2020. (Graphic: Zinnov) In its latest industry rankings, Zinnov positioned L&T Technology Services as an “Expansive and Established” engineering partner with deep domain competencies in overall ER&D services. LTTS has been rated in the “Leadership Zone” across verticals such as Automotive, Aeros
Guardant Health and Vall d’Hebron Institute of Oncology Announce Partnership to Establish First Guardant-Based Liquid Biopsy Testing Service in Europe18.1.2021 09:00:00 CET | Press release
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and Vall d’Hebron Institute of Oncology (VHIO), one of Europe’s leading cancer research organizations, have agreed to enter into a partnership to establish in-house liquid biopsy testing services, using Guardant Health’s industry-leading proprietary digital sequencing platform, at VHIO’s facility in Barcelona, Spain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210118005057/en/ The service is expected to become operational in 2021 and will be available for clinical research and clinical care — starting with private patients, followed by expansion into the public healthcare system over time. “We are pleased to announce this partnership with VHIO which will bring liquid biopsy comprehensive genomic testing to more cancer patients in Spain and beyond,” said Helmy Eltoukhy, Guardant Health CEO. “Our vision is that all cancer patients globally have access
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