Abiomed Acquires preCARDIA, a Breakthrough Medical Device Company, to Improve Outcomes for Heart Failure Patients
Abiomed (NASDAQ: ABMD) has acquired preCARDIA, developer of a proprietary catheter and controller that will complement Abiomed’s product portfolio to expand options for patients with acute decompensated heart failure (ADHF). The preCARDIA system is uniquely designed to rapidly treat ADHF-related volume overload by effectively reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210601005259/en/
Annually, more than one million patients are admitted to hospitals in the United States with ADHF. Despite available pharmaceutical treatments, heart failure is the leading cause of hospitalization in patients older than 65 years of age. preCARDIA provides heart failure specialists a minimally invasive solution with the potential to improve patient outcomes and lower the cost of care by providing early intervention with this new technology.
preCARDIA’s catheter-based system includes a proprietary superior vena cava (SVC) balloon that delivers programmed intermittent occlusion of the SVC. Potential benefits for patients include improved response to medical management of ADHF, reduced duration of hospital stay, reduced re-hospitalizations and improved quality of life. The system is based on an invention by Navin Kapur, MD, and Richard Karas, MD, PhD, at the Molecular Cardiology Research Institute at Tufts Medical Center in Boston.
The design of the preCARDIA system allows for straightforward placement by physicians and hemodynamic monitoring by medical staff. The system has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
“Abiomed, with its mission of resting and recovering hearts, is uniquely positioned to build on the legacy of what we started,” said Lisa Wipperman Heine, president and chief executive officer at preCARDIA. “I am confident that the addition of our technology into Abiomed’s product portfolio will further improve outcomes for heart failure patients.”
preCARDIA completed enrollment of 30 patients in an FDA early feasibility study (EFS), which demonstrated acute technical success and significant reduction in cardiac filling pressures and rapid diuresis. Additionally, all patients were free of device- or procedure-related major adverse events through 30 days.
“Heart failure is a devastating condition associated with excess fluid overload known as congestion. preCARDIA is a breakthrough technology that regulates blood flowing into the heart known as preload, thereby reducing congestion and improving heart and kidney function,” said Navin Kapur, MD, physician-scientist and investigator in the Molecular Cardiology Research Institute at Tufts Medical Center, and the chief medical advisor and chair of preCARDIA’s Scientific Advisory Board. “This novel approach has the potential to be a revolutionary tool for the treatment of millions of patients suffering from acute heart failure worldwide.”
“We look forward to advancing preCARDIA’s technology through the regulatory process and expanding our relationship with heart failure specialists to help improve outcomes in early stage acute decompensated heart failure patients, a new patient population for Abiomed,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “This acquisition aligns with Abiomed’s principles of leading in technology and innovation and putting patients first.”
The preCARDIA system is available for investigational use only and is not approved for use outside of clinical studies. A projected timeline for commercialization will be announced later this fiscal year.
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide 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: www.abiomed.com.
preCARDIA is dedicated to improving patients’ quality of life through pioneering clinically advanced technology that offers an alternative solution for physicians and their patients suffering from ADHF. preCARDIA’s current technology, a proprietary balloon catheter and pump controller, is designed to address ADHF through cardio-renal volume unloading via intermittent superior vena cava (SVC) occlusion.
The company was founded & incubated by MD Start and is headquartered in St. Paul, Minnesota, USA.
CAUTION: The preCARDIA System is an investigational device and is limited by Federal (or United States) Law to investigational use. For more information, please visit: www.precardia.com.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
QCT and Robin.io Announce Strategic Partnership to Modernize 5G Solutions14.6.2021 15:00:00 CEST | Press release
Robin.io, the 5G and application automation platform company, and Quanta Cloud Technology (QCT), a global data center solution provider, today announced a strategic partnership through which the companies will jointly offer solutions that significantly reduce the costs, complexities and deployment times for mobile network operators (MNOs) and communication service providers (CSPs) rolling out next-gen networks and services. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210614005152/en/ The Robin.io core technologies — Multi Cluster Automation Platform (MDCAP), Robin Cloud Native Platform (CNP), Robin Cloud Native Storage (CNS) — hyper-automation that orchestrates and manages the lifecycles of bare-metal infrastructures, 3rd party appliances, Virtual Network Functions (NVFs), Cloud-native Network Functions (CNFs) and services, with built-in logging, monitoring and policy engines, for closed loop automation, managed through a
Quest Appoints Brian Brugman as Director of Research14.6.2021 14:00:00 CEST | Press release
Quest Partners LLC (“Quest”), a quantitative investment firm managing nearly $1.8 billion of assets on behalf of some of the world’s largest institutions, today announced that Brian Brugman joined the firm as Director of Research. In the role, Mr. Brugman will spearhead Quest’s research and investment strategy development alongside Quest’s Founder and Chief Investment Officer, Nigol Koulajian. He will also join Quest’s management committee. “Brian’s breadth of experience in designing quantitative strategies with considerations around convexity risk bodes well with Quest’s differentiated approach to systematic macro trading,” said Mr. Koulajian. “He is joining as we are nearing the completion of a multi-year process to build out a state-of-the-art investment infrastructure to dramatically increase the efficiency and scalability of our research process. Brian will play a critical role in leveraging that technology and our research team to pursue highly valuable, negatively correlated ret
Hisense's European Sales Revenue Surges to 113%, Successfully Strengthen European Competitive Position and Profitability14.6.2021 13:00:00 CEST | Press release
Hisense, the official sponsor of UEFA EURO 2020, celebrates the official kick-off of EURO 2020 in Italy. Football, as one of the top events in Europe, creates a chance for Hisense to build emotional connections with European consumers. Ever since the sponsorship of UEFA EURO 2016, through supporting sport event and technology innovation, Hisense gains many recognitions and praises from European consumers; its brand awareness increased by 6%. In 2021, Hisense’s sales revenue in the European market grew by 113% year-on-year, with more than 355% and 185% growth in key markets such as Poland and France. Hisense is dedicated to developing and producing cutting-edge technology, adopting localization strategy to ensure different markets' consumer needs and product experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210614005257/en/ Fans can find Hisense Logo on EURO 2020 Festival Tower (Photo: Business Wire) Localization man
Moody’s Highlights Its Commitment to Sustainability Leadership14.6.2021 13:00:00 CEST | Press release
Today Moody’s Corporation (NYSE:MCO) released its inaugural Stakeholder Sustainability and Diversity, Equity and Inclusion (DE&I) reports, which highlight its ongoing commitment to sustainability leadership by placing sustainability considerations at the core of its global business and operations. The 2020 Stakeholder Sustainability Report details Moody’s focus on sustainability and its progress toward incorporating environmental, social and governance (ESG) considerations across its products and corporate operations. Moody’s DE&I Report details new goals established to enhance diverse representation across its global workforce and highlights programs and partnerships created to advance DE&I in its workplace, communities and the wider business community. “Sustainability is an integral part of who we are and how we operate at Moody’s,” said Robert Fauber, President and Chief Executive Officer. “Our Stakeholder Sustainability and DE&I reports detail the many ways in which we are committe
Velodyne Lidar Introduces Next-Generation Velabit™ Sensor14.6.2021 12:48:00 CEST | Press release
Velodyne Lidar, Inc. (Nasdaq: VLDR, VLDRW) today introduced the next generation of its Velabit™ sensor, which addresses the cost, safety, and design challenges of autonomous solutions while delivering state-of-the-art performance. Equipped with Velodyne's breakthrough proprietary micro-lidar array architecture (MLA), the Velabit delivers on what Velodyne customers asked for - an ultra-wide field of view (FoV) and higher resolution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210614005080/en/ Velodyne Lidar introduced the next generation of its Velabit™ sensor, which addresses the cost, safety, and design challenges of autonomous solutions while delivering state-of-the-art performance. (Photo: Velodyne Lidar) The solid-state Velabit sensor now has a simultaneously achievable maximum horizontal FoV of 90° and maximum vertical FOV of 70°, approximately three times more points per second than the previous model. The next gene
Thales and Google Expand Partnership to Support Enhanced Privacy and Confidentiality Capabilities for Google Workspace14.6.2021 12:00:00 CEST | Press release
Thales today announced that its CipherTrust Manager and SafeNet Trusted Access have been integrated with Google Workspace Client-side encryption (beta coming soon), a new privacy and confidentiality offering for Google Workspace users. Providing enhanced key management capabilities and identity protection, customers can benefit from improved regulatory compliance and data ownership by allowing them to maintain ownership of keys used to encrypt Google Workspace documents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210614005060/en/ © Thales With many countries developing strict data security regulations, such as GDPR and Schrems II in Europe, CCPA in NORAM and NDB in APAC, the regulatory landscape is becoming increasingly complex for organisations to navigate. What’s more, with three-quarters (74%) of global organisations planning to keep part of their workforce remote after the pandemic, there is an increasing need for a
Celltrion announces positive top-line results from global Phase III trial of regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment14.6.2021 10:15:00 CEST | Press release
Celltrion Group today announced top-line efficacy and safety data from the global Phase III clinical trial, demonstrating that anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59), met all primary and key secondary endpoints in patients with mild- to- moderate symptoms of COVID-19 (n=1,315). Results showed that CT-P59 significantly reduced the risk of hospitalisation or death by 72% for patients at high- risk of progressing to severe COVID-19 up to Day 28, compared to placebo, meeting the primary efficacy endpoint [3.1 vs. 11.1 %, p-value< 0.0001]. CT-P59 also significantly reduced the risk of hospitalisation or death by 70% in all patients, meeting the first key secondary endpoint [2.4 vs. 8.0 %, p-value< 0.0001]. The trial also met the other key secondary endpoints, including faster and persistent reduction in symptom duration. Patients treated with CT-P59 (40mg/kg) recovered at least 4.7 days earlier than those in the placebo-treated patients [median 9.3 vs. m