Hemodynamic Support Devices

This hemodynamic support systems channel includes content on intra-aortic balloon pumps (IABP), percutaneous ventricular assist devices (pVAD) like the Impella or TandemHeart, extracorporeal membrane oxygenation (ECMO), and ventricular assist devices (VAD). This channel also includes use of these devices in support of patients in cardiogenic shock and advanced heart failure.

The objective of this study was to assess the safety and efficacy of SELUTION SLR, MedAlliance’s novel sirolimus-eluting balloon, for endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and popliteal artery (PA).

News | Drug-Eluting Balloons

Excellent 12-Month Results from SELUTION SFA Trial Presented at JET

May 30, 2023 — Twelve-month results from the SELUTION SFA trial have been presented for the first time at the Japan ...

May 30, 2023

Figure 1. Results from the PROTECT II RCT, PROTECT III and RESTORE-EF Pooled Data Analysis

News | Intra-Aortic Balloon Pumps (IABP)

Analysis Showcases Potential for More Complete Revascularizations with Impella Compared to IABP during HRPCI

May 19, 2023 — Abiomed, part of Johnson & Johnson MedTech[1], announces results of a third-party analysis showing that ...

May 19, 2023

Edwards Lifesciences announced that new data from the Benchmark Registry in Europe demonstrated the safety and effectiveness of this streamlined treatment pathway for patients receiving transcatheter aortic valve replacement (TAVR) with balloon-expandable valves.

News | Structural Heart

Data from Benchmark Registry Demonstrate Improved TAVR Efficiency with Preserved Patient Safety

May 17, 2023 — Edwards Lifesciences announced that new data from the Benchmark Registry in Europe demonstrated the ...

May 17, 2023

This study evaluates SELUTION SLR in the treatment of occlusive disease of the superficial femoral artery (SFA) and proximal popliteal artery (PPA) and has been designed to support FDA approval

News | Drug-Eluting Balloons

MedAlliance Enrolls First US Patient into its Third FDA IDE Study: SFA SELUTION4SFA

May 4, 2023 — The first US patient has been enrolled in the SELUTION4SFA Sirolimus DEB study by Dr. Arthur Lee at the Ca ...

May 04, 2023

According to a new release issued by the U.S. Food and Drug Administration (FDA), Datascope, a subsidiary of Getinge, is recalling Cardiosave Hybrid IABPs and Rescue IABPs because a communication loss between the executive processor printed circuit board assembly (PCBA) and the video generator PCBA may cause an unexpected shutdown

News | Intra-Aortic Balloon Pumps (IABP)

Datascope/Getinge Issues New Recall of Certain Cardiosave Hybrid and Rescue IABPs for Risk of Unexpected Shutdown

March 31, 2023 — According to statement issued by the U.S. Food and Drug Administration (FDA), Datascope, a subsidiary ...

March 31, 2023

Late-breaking data presented at THT shows substantial fluid loss and improvements in kidney and cardiac function at 30 days after Aortix therapy

News | Heart Failure

Aortix Pump Therapy Leads to Rapid Decongestion and Improved Kidney Function in Hospitalized Patients with Heart Failure and Worsening Renal Function

March 21, 2023 — Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac ...

March 21, 2023

Datascope, a subsidiary of Getinge, is recalling Cardiosave Hybrid IABPs and Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown

News | Intra-Aortic Balloon Pumps (IABP)

Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After Coiled Cord Connection Failure

March 20, 2023 — According to a statement issued by the U.S. Food and Drug Administration (FDA), Datascope, a subsidiary ...

March 20, 2023

News | Drug-Eluting Balloons

Over 1,000 Patients Enrolled in Landmark SELUTION DeNovo Study

March 14, 2023 —MedAlliance has announced enrollment of over 1,000 patients in its ground-breaking SELUTION DeNovo coron ...

March 14, 2023

Single Intra-Myocardial Intervention with Rexlemestrocel-L Reduced Cardiovascular Death, Myocardial Infarction or Stroke Over Mean Follow-Up of 30 Months in High-Risk Patients with Chronic Heart Failure

News | Ventricular Assist Devices (VAD)

DREAM-HF Phase 3 Trial Results for Mesoblast Cell Therapy in Heart Failure Published in Journal of the American College of Cardiology

March 1, 2023 — Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, today ...

March 01, 2023

Featured presentation on the time to clinical benefit of sotagliflozin in people with worsening heart failure

News | Heart Failure

Abiomed at CRT 2023: Benefits of Impella-Supported High Risk PCI and Impella Innovation

February 24, 2023 — Abiomed, Inc., part of Johnson & Johnson MedTech[1], announced that results from a study on Impella ...

February 24, 2023

Harmony Transcatheter Pulmonary Valve System is the first FDA-approved minimally invasive valve designed for the right side of the heart

News | Congenital Heart

Medtronic Relaunches First-of-its-kind Transcatheter Pulmonary Valve Replacement System for Congenital Heart Disease

February 24, 2023 — Medtronic today announced the relaunch of its Harmony Transcatheter Pulmonary Valve (TPV) System, a ...

February 24, 2023

The first US patient has been enrolled at Medstar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR to support FDA approval.

News | Drug-Eluting Balloons

MedAlliance Leads US Sirolimus DEB Race: First US Patient Enrolled into SELUTION SLR Coronary Sirolimus DEB Study

January 27, 2023 — The first US patient has been enrolled at Medstar Washington Hospital Center in the SELUTION4ISR ...

January 27, 2023

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

News | Intra-Aortic Balloon Pumps (IABP)

Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps

January 25, 2023 — According to a new release from the U.S. Food and Drug Administration (FDA), Datascope, a subsidiary ...

January 25, 2023

Patients seen at transplant centers had almost 80% higher odds to receive “bridge-to-transplant” designation

News | Heart Failure

Medicare Policy Change Could Increase Inequity in Heart Transplant Access, Study Finds

January 13, 2023 — A change to Medicare policy surrounding heart transplant may lead to increased inequities in access ...

January 13, 2023

SELUTION SLR, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of coronary de novo lesions.

News | Drug-Eluting Balloons

MedAlliance Selution SLR is the First DEB to Receive Coronary de novo IDE Approval, its Fourth FDA IDE DEB Approval

January 12, 2023 — Selution SLR, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA ...

January 12, 2023