Impella

Abiomed to Highlight Data Analysis Identifying Complex Clinical Profile of Patients Receiving Impella-Supported HRPCI at TCT Symposium

Retrieved on: 
Monday, October 23, 2023

The seven studies include an analysis of the characteristics of PROTECT III patients that demonstrates how physicians are distinguishing which patients are high-risk and appropriate for Impella-supported HRPCI procedures.

Key Points: 
  • The seven studies include an analysis of the characteristics of PROTECT III patients that demonstrates how physicians are distinguishing which patients are high-risk and appropriate for Impella-supported HRPCI procedures.
  • The data shows that 82.5 percent of patients have features in all three high-risk domains: comorbidities, complex coronary anatomy and adverse hemodynamics.
  • It also demonstrates that 99.6 percent of patients have risk factors from two or more of the high-risk domains.
  • Abiomed's World Connect TCT Symposium takes place on Tuesday, Oct. 24 between 11 a.m.–12 p.m. PDT on Level 2 in the Presentation Theater.

Saranas Successfully Completes Enrollment of Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support

Retrieved on: 
Monday, September 18, 2023

The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system.

Key Points: 
  • The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system.
  • Patients undergoing complex high-risk PCI with mechanical circulatory support (MCS) via Impella and transfemoral arterial approach are enrolled as study participants.
  • The Early Bird Bleed Monitoring System is used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.
  • The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.

Saranas Reaches Midpoint for Enrollment in Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support

Retrieved on: 
Monday, March 27, 2023

The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system.

Key Points: 
  • The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system.
  • Patients undergoing complex high-risk PCI with mechanical circulatory support (MCS) via Impella and transfemoral arterial approach are enrolled as study participants.
  • “This is an important milestone in our efforts to continue building clinical evidence to support the utility of the Early Bird device.
  • The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.

FDA Approves Impella ECP Pivotal Heart Pump and First Patients Enrolled in Pivotal Clinical Trial

Retrieved on: 
Wednesday, December 21, 2022

Abiomed (Nasdaq: ABMD) announces the United States Food and Drug Administration (FDA) has approved the version of Impella ECP that will be used in the Impella ECP Pivotal Trial, and the first two patients have been enrolled in the trial.

Key Points: 
  • Abiomed (Nasdaq: ABMD) announces the United States Food and Drug Administration (FDA) has approved the version of Impella ECP that will be used in the Impella ECP Pivotal Trial, and the first two patients have been enrolled in the trial.
  • (Graphic: Business Wire)
    Impella ECP is the world’s smallest heart pump and the only heart pump compatible with small bore access and closure techniques.
  • Both patients enrolled in the trial received Impella ECP support during challenging left main coronary bifurcation stent procedures involving heavily calcified lesions.
  • The Impella ECP Pivotal Clinical Trial received FDA approval on March 2, 2022 and will enroll up to 217 patients in the U.S. Additional details about the pivotal trial are available here .

First Patients in the World Treated with Impella RP Flex with SmartAssist

Retrieved on: 
Monday, December 5, 2022

Abiomed (Nasdaq: ABMD) announces the first three patients in the world have been treated with Impella RP Flex with SmartAssist, Abiomeds newest heart pump for patients experiencing right heart failure.

Key Points: 
  • Abiomed (Nasdaq: ABMD) announces the first three patients in the world have been treated with Impella RP Flex with SmartAssist, Abiomeds newest heart pump for patients experiencing right heart failure.
  • Dr. Anderson and his colleague Yuriy Dudiy, MD, implanted Impella RP Flex on a 71-year-old patient who was having a minimally invasive valve surgery.
  • Dr. Andersons second Impella RP Flex case involved a 51-year-old patient who experienced cardiac arrest and received Impella support for four days after valve surgery.
  • Impella RP Flex is the latest iteration of the Impella RP heart pump.

Johnson & Johnson to Acquire Abiomed

Retrieved on: 
Tuesday, November 1, 2022

The addition of Abiomed is an important step in the execution of our strategic priorities and our vision for the new Johnson & Johnson focused on Pharmaceutical and MedTech, said Joaquin Duato, Chief Executive Officer of Johnson & Johnson.

Key Points: 
  • The addition of Abiomed is an important step in the execution of our strategic priorities and our vision for the new Johnson & Johnson focused on Pharmaceutical and MedTech, said Joaquin Duato, Chief Executive Officer of Johnson & Johnson.
  • Assuming the closing of the tender offer, Johnson & Johnson will acquire any shares of Abiomed not tendered into the tender offer through a merger of Merger Sub with and into Abiomed for the same per share consideration as will be payable in the tender offer.
  • Johnson & Johnson and Abiomed will conduct a conference call with investors to discuss the transaction today, November 1, 2022 at 8:00 a.m.
  • Copies of these filings are available online at www.sec.gov , or, in the case of Johnson & Johnson, at www.jnj.com or on request from Johnson & Johnson, or, in the case of ABIOMED, at www.abiomed.com or on request from ABIOMED.

 Abiomed Creates Patient Assistance Program to Address Disparities in Healthcare

Retrieved on: 
Wednesday, October 26, 2022

Abiomed (Nasdaq: ABMD) announces a new program to address healthcare disparities in underserved communities, as new data provides an example of how better access to Impella heart pumps can improve health equity for non-Caucasian cardiovascular patients.

Key Points: 
  • Abiomed (Nasdaq: ABMD) announces a new program to address healthcare disparities in underserved communities, as new data provides an example of how better access to Impella heart pumps can improve health equity for non-Caucasian cardiovascular patients.
  • As a result of this subgroup analysis, and the abundance of other clinical data that demonstrates the benefits of Impella heart pumps in high-risk PCI, cardiogenic shock and right heart failure, Abiomed is establishing a patient assistance program to help reduce treatment disparities in the healthcare system.
  • Abiomed will honor Dr. Austen with this healthcare disparity program as a service to patients and communities in need, to which he dedicated his lifes work, said Michael R. Minogue, Abiomed Chairman, President and Chief Executive Officer.
  • For more information about the W. Gerald Austen Disparities in Healthcare Initiative, please visit www.abiomed.com/dih-initiative .

Abiomed Successfully Completes All Impella Post-Approval Studies for High-Risk PCI, Cardiogenic Shock, Post-Cardiotomy Cardiogenic Shock and Right Heart Failure

Retrieved on: 
Thursday, October 20, 2022

The FDAs action is another affirmation that Impella heart pumps are safe and effective for cardiogenic shock, high-risk PCI, post-cardiotomy cardiogenic shock, cardiogenic shock in the setting of myocarditis or cardiomyopathy, and right heart failure.

Key Points: 
  • The FDAs action is another affirmation that Impella heart pumps are safe and effective for cardiogenic shock, high-risk PCI, post-cardiotomy cardiogenic shock, cardiogenic shock in the setting of myocarditis or cardiomyopathy, and right heart failure.
  • In total, Abiomed completed five post-approval studies for Impella over the seven years since its initial PMA was received.
  • The totality of Impella data collected in the U.S., Europe and Japan demonstrates Impella improves outcomes and lowers costs.
  • Impella is the most studied heart pump in the history of the FDA, with studies being conducted from 2006 to the present.

U.S. FDA Grants 510(k) Clearance for Impella Low Profile Sheath

Retrieved on: 
Monday, October 17, 2022

The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath.

Key Points: 
  • The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath.
  • As a result of its smaller size and other technological advancements, the Low Profile Sheath will facilitate easier Impella insertion and removal, reduce procedural steps and help improve outcomes.
  • View the full release here: https://www.businesswire.com/news/home/20221017005313/en/
    Abiomeds 14 Fr Impella Low Profile Sheath, in its assembled state (Photo: Business Wire)
    The Low Profile Sheath is the first sheath specifically engineered to be compatible with the Impella single-access technique, which removes the need for an additional access site.
  • Abiomed will begin a phased roll-out of the Impella Low Profile Sheath this quarter.

Yale University Study Demonstrates Significant Survival Benefit in High-Risk PCI with Impella Support

Retrieved on: 
Thursday, October 13, 2022

Dr. Lansky is also the director of the Yale Heart and Vascular Clinical Research Program and the Yale Cardiovascular Research Center, which specializes in the evaluation of interventional devices.

Key Points: 
  • Dr. Lansky is also the director of the Yale Heart and Vascular Clinical Research Program and the Yale Cardiovascular Research Center, which specializes in the evaluation of interventional devices.
  • The study examined patients in the Premier Healthcare Database treated between 2016 and 2019 with Impella or IABP for non-emergent high-risk PCI.
  • The study found:
    In-hospital survival was significantly higher with Impella compared to IABP (unadjusted 95.3% vs. 91.0%, p=0.0002; adjusted odds ratio (OR) 1.55, 95% confidence interval (CI) 1.02, 2.36, p=0.042).
  • further validate and extend the results of other studies of Impella in high-risk PCI, including the PROTECT II randomized controlled trial (RCT) , the PROTECT III study and the RESTORE EF study .