Business Wire

Early Feasibility Study Demonstrates Successful Use of Abiomed’s preCARDIA Technology

Share

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/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

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.

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

Business Wire
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

RevBio Launches an Experiment for its Regenerative Biomaterial on the International Space Station9.12.2022 20:04:00 CET | Press release

RevBio, Inc., announced that anexperiment to study Tetranite®, the company’s regenerative bone adhesive biomaterial, has successfully been initiated onboard the International Space Station (ISS). On Saturday, November 26, 2022, the study materials were launched to the space station on SpaceX’s 26th Commercial Resupply Services (SpaceX CRS-26) mission, sponsored by the ISS National Laboratory. This in vivo research, which will be conducted over the next two months on the ISS, will examine the biomaterial’s ability to regenerate bone when used in a microgravity environment where bone growing conditions and the ability to regenerate new bone tissue is significantly compromised. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221201005635/en/ RevBio Launches an Experiment for its Regenerative Biomaterial on the International Space Station. This Experiment will Examine TETRANITE’S Ability to Regenerate Bone under the Condition of

Datopotamab Deruxtecan Showed Promising Responses as Monotherapy and in Combination with Durvalumab in Patients with Metastatic Triple Negative Breast Cancer in Two Early Trials9.12.2022 14:00:00 CET | Press release

Updated results from the TROPION-PanTumor01 phase 1 trial showed datopotamab deruxtecan (Dato-DXd) continued to demonstrate encouraging responses in patients with heavily pretreated metastatic triple negative breast cancer (TNBC) and disease progression following standard treatment. Results were presented today as a poster presentation (Abstract #P6-10-03) at the 2022 San Antonio Breast Cancer Symposium (#SABCS22). Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN). Approximately 15% of breast cancers are considered triple negative and are associated with higher disease recurrence and worse prognosis compared to other breast cancer subtypes.1,2 It is estimated that only 12% of patients with metastatic TNBC survive five years after diagnosis and median overall survival is between 12 to 18 months.1,3 In the TNBC cohort of TROPION-PanTumor01 (n=44)

Takeda to Present Data at 64th American Society of Hematology (ASH) Annual Meeting, Demonstrating Commitment to Patients with Hematologic Cancers and Other Blood Diseases9.12.2022 14:00:00 CET | Press release

Takeda(TSE:4502/NYSE:TAK) today announced that it will present 15 company-sponsored abstracts at the 64th American Society of Hematology (ASH) Annual Meeting being held December 10-13, 2022 in New Orleans. Takeda’s latest research focuses on improving long-term outcomes for patients with hematologic diseases. Takeda’s presentations will include oral sessions detailing a three-year update of the Phase 3 OPTIC trial demonstrating the efficacy and safety of ICLUSIG® (ponatinib) in patients with resistant chronic-phase chronic myeloid leukemia (CP-CML), and results from a first-in-human Phase 1/2 study evaluating modakafusp alfa (TAK-573) in patients with relapsed / refractory multiple myeloma. “Our latest research is focused on investigating novel mechanisms of action, as well as optimizing approved treatments to improve long-term outcomes and more deeply understand and address unmet needs for patients across a range of hematologic diseases,” said Awny Farajallah, M.D., Head of Global Med

Tecnotree Advances to Acquire Top AIML Platform - CognitiveScale in North America to further Enhance 5G Use case Penetration9.12.2022 13:23:00 CET | Press release

Tecnotree is a market leader in 5G digital Business Support Systems (BSS), with AI/ML capabilities and multi-cloud extensibility. Tecnotree’s global footprint with over 90 Telecom customers in 70 countries around the world, supports ecosystems of over 1 billion subscribers. Tecnotree is the first Digital Platform Service provider to be Platinum Badge Certified by TM Forum for Real-world Open API standards. The company also provides B2B2X partner ecosystem and fintech services for monetization beyond connectivity across gaming, healthcare, education, and banking. Tecnotree has been recognized by Gartner for revenue management and monetization as well as for customer experience management solutions and enjoys the position of a leading stock on the Helsinki Nasdaq since 2020. CognitiveScale (CS) is United States based pioneer in the space of AI Engineering and provides solutions for scalable enterprise AI development and deployment. CognitiveScale is backed by over 100 granted AI patents

Another Sustainability Award for NTHU9.12.2022 10:00:00 CET | Press release

National Tsing Hua University (NTHU) in Taiwan has been awarded the Taiwan University Sustainability Award for the second year in a row! The Award was announced at the 15th Taiwan Corporate Sustainability Awards (TCSA) recently held by the Taiwan Institute for Sustainable Energy (TAISE). Standing out amongst the 47 participating universities, NTHU was ranked first in the comprehensive evaluation, and in the individual competitions received the University Sustainability Report Gold Award. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221209005001/en/ NTHU president W. John Kao (right) accepting the Taiwan University Sustainability Award from You Si-kun, president of the Legislative Yuan. (Photo: National Tsing Hua University) The judges cited the exemplary way in which NTHU has adopted an innovative approach to integrating classroom learning, campus activities and social service, thereby enriching students’ education and cre

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