Early Feasibility Study Demonstrates Successful Use of Abiomed’s preCARDIA Technology
Abiomed (NASDAQ: ABMD) announces the successful results of the first-in-human early feasibility study of the preCARDIA system. The preCARDIA system is designed to improve decongestion in acutely decompensated heart failure (ADHF) patients by intermittently occluding the superior vena cava. The results of the study published this week in the journal Circulation: Heart Failure.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220112005319/en/
The preCARDIA system is placed in the heart to intermittently occlude the superior vena cava. (Graphic: Business Wire)
Despite available pharmaceutical treatments, heart failure is the leading cause of hospitalization in patients older than 65 years of age. Diuretics may help to improve heart failure symptoms and heart function by reducing fluid overload. However, diuretics take time to work and may be ineffective in patients with chronic heart failure. preCARDIA is designed to reduce filling pressure as blood enters the heart and lungs, which may enable the heart and kidneys to work more effectively, potentially providing therapy for patients non-responsive to diuretics, estimated to be approximately 300,000 of the one million U.S. ADHF admissions per year.
The multicenter, prospective, single-arm VENUS-HF Early Feasibility Study examined 30 patients with ADHF who were assigned preCARDIA therapy for 12 or 24 hours. The primary endpoint was a composite of major adverse events through 30 days. The study found:
- Freedom from device- or procedure-related major adverse events in 100% of patients (n=30/30)
- Successful placement, activation and removal of preCARDIA in 97% of patients (n=29/30)
- Right atrial pressure decreased 34% from baseline (p<0.001)
- Pulmonary capillary wedge pressure decreased 27% from baseline (p<0.001)
- Urine output increased by 130% from pretreatment values (p<0.01)
- Net fluid output increased by 156% from pretreatment values (p<0.01)
“The study met the safety and feasibility endpoints and suggests for the first time that with the preCARDIA system it is possible to rapidly reduce cardiac filling pressures and augment urine output by intermittently occluding the superior vena cava in patients with ADHF,” said Navin Kapur, MD, the study’s lead author and executive director of the CardioVascular Center for Research and Innovation at Tufts Medical Center.
The results support additional study of preCARDIA. In November, the United States Food and Drug Administration (FDA) authorized preCARDIA’s early feasibility study to be expanded by 30 additional patients to a total of 60 patients.
preCARDIA 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 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.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220112005319/en/
Contact information
Media:
Tom Langford
Director of Communications
+1 (978) 882-8408
tlangford@abiomed.com
Investors:
Todd Trapp
Vice President and Chief Financial Officer
+1 (978) 646-1680
ttrapp@abiomed.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
With 40% of Agentic AI Projects Predicted to Fail, Leading Software Developer Says Compliance Is the One Place Where Agentic AI Will Thrive2.12.2025 02:01:00 EET | Press release
The CEO of one of the world’s leading global compliance software developers, Ideagen, has today (December 2, 2025) said compliance represents the one domain where autonomous AI will succeed – despite technology insights company Gartner® warning "… over 40% of agentic AI projects will be canceled by the end of 2027”. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251201511477/en/ Ben Dorks, Ideagen CEO Speaking at the launch of their own agentic AI platform Ideagen Mazlan, Ben Dorks said: “Autonomous AI will succeed in compliance because failure is measurable, stakes are high and outcomes are binary. “AI that continuously monitors jurisdictional or industry specific compliance frameworks, detects patterns across thousands of records, raises actions for others to follow, flags gaps before audits, autonomously? That's agentic. It will literally save lives and is the most transformative shift in protecting people, products and p
VeriSilicon’s NPU IP VIP9000NanoOi-FS has Achieved ISO 26262 ASIL B Certification2.12.2025 02:00:00 EET | Press release
VeriSilicon (688521.SH) today announced that its NPU IP VIP9000NanoOi-FS has successfully achieved ISO 26262 ASIL B certification, marking a significant milestone in the functional safety capabilities of the company’s neural network processing unit portfolio. This IP features an architecture streamlined for seamless SoC integration, delivering high-quality inference with low power consumption and a compact silicon footprint. The certificate was issued by SGS-TÜV Saar, an international testing, inspection and certification institution. As part of VeriSilicon’s VIP9000 series, the VIP9000NanoOi-FS IP is designed for automotive and edge AI applications, providing high-performance neural network processing with a safety-compliant architecture. The IP supports a wide range of AI inferencing models including Large Language Models (LLMs) and Convolutional Neural Networks (CNNs), with hardware-accelerated AI inference, enabling real-time applications such as object and scene detection, augment
UMA Launches from Europe to Shape the Global Future of Physical AI2.12.2025 00:52:00 EET | Press release
UMA (Universal Mechanical Assistant), a new robotics intelligence company founded by former leaders from Tesla, Google DeepMind, Nvidia and Hugging Face, launches today with a clear goal: to bring advanced AI into the physical world and build humanoid robots ready for real work, in real environments, at scale. UMA’s founders were instrumental in shaping the last decade of breakthroughs in deep learning, robotics and open-source AI. They are convinced that the next era of artificial intelligence won’t unfold on screens, it will happen in warehouses, hospitals, labs, factories and homes, where machines must face friction, unpredictability and human complexity. UMA is built for this transition: from digital intelligence to physical autonomy. AI Is Moving Off the Screen and into the World The past ten years gave rise to generative models, multimodal systems and language-based intelligence. The next decade will be defined by robotics, powered by an AI that can see, move, manipulate and make
FlightSafety International Appoints Eric Hinson as Chief Executive Officer2.12.2025 00:00:00 EET | Press release
FlightSafety International Inc. today announced the appointment of Eric Hinson as chief executive officer, effective immediately. Hinson will succeed former president Barbara Telek who recently announced her retirement. Hinson’s appointment marks a return to FlightSafety. He served as an executive vice president from 2009 to 2012 before leaving to be the president and CEO of Simcom International, Inc. Hinson started his aviation career as a naval aviator flying tactical aircraft in training, fleet, and operational test squadrons. Today, he is an active ATP-rated pilot with more than 5,000 total flight hours. He brings a unique operational perspective to the position—one that blends executive leadership with firsthand experience. In addition to FlightSafety and Simcom, Hinson has served in a variety of senior leadership positions at leading aviation companies, including Honeywell, Gulfstream, and Piaggio Aerospace. He also served as a board member of the General Aviation Manufacturer As
Ubigi Voted Most Reliable eSIM for Mobile Professionals According to Latency Report 20251.12.2025 17:13:00 EET | Press release
Ubigi, a pioneer in eSIM solutions for travellers and connected professionals, has been ranked number one worldwide for connection quality according to the Latency Report 2025. This independent study evaluates eSIMs based on three key criteria: latency, jitter and packet loss. Thanks to its cutting-edge international network infrastructure, Ubigi has established itself as the benchmark for reliability for mobile professionals. Its architecture is based on seven Packet Gateways (P-GWs) spread across Europe, Asia and the Americas, allowing data to transit through the Internet point closest to the user. The result: latency reduced by a factor of two to five depending on the area and optimal stability for video conferencing, VPN and cloud services. Ubigi's performance, validated by the Latency Report 2025, stands out: Average latency: 35 ms in Europe, 92 ms in Asia; Jitter: only 5 ms; Packet loss: < 0.2%, one of the best reliability ratings measured. These results, confirmed by tests in Li
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