• Popular
    • Medicine
    • Radiology
    • Cardiology
    • Surgery
    • Nanomedicine
    • Military Medicine
    • Rehab
  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS
  • Submit PR
  • Log in
Medgadget
Medgadget
  • Popular
    • Medicine
      Magnetic Dressing Improves Diabetic Wound Healing

      Magnetic Dressing Improves Diabetic Wound Healing

      Eko’s Newest CORE 500 Stethoscope: A Review

      Eko’s Newest CORE 500 Stethoscope: A Review

      Microfluidic System Incorporates Eight Organ Tissues for Drug Testing

      Microfluidic System Incorporates Eight Organ Tissues for Drug Testing

      Suction Cup Delivers Drugs Through Cheek

      Suction Cup Delivers Drugs Through Cheek

    • Radiology
      Shear-Thinning Biomaterial for Embolic Applications: Interview with Upma Sharma, President and CEO of Arsenal Medical

      Shear-Thinning Biomaterial for Embolic Applications: Interview with Upma Sharma, President and CEO of Arsenal Medical

      Ultrasound-Equipped Bra Monitors for Breast Cancer

      Ultrasound-Equipped Bra Monitors for Breast Cancer

      Portable and Radiation-Free Imaging with Magnetic Nanoparticles

      Portable and Radiation-Free Imaging with Magnetic Nanoparticles

      Imaging Technique Reveals Living Brain Tissue in its Complexity

      Imaging Technique Reveals Living Brain Tissue in its Complexity

    • Cardiology
      Eko’s Newest CORE 500 Stethoscope: A Review

      Eko’s Newest CORE 500 Stethoscope: A Review

      Shear-Thinning Biomaterial for Embolic Applications: Interview with Upma Sharma, President and CEO of Arsenal Medical

      Shear-Thinning Biomaterial for Embolic Applications: Interview with Upma Sharma, President and CEO of Arsenal Medical

      Ultrasound-Equipped Bra Monitors for Breast Cancer

      Ultrasound-Equipped Bra Monitors for Breast Cancer

      3D Printed Heart Muscle Beats

      3D Printed Heart Muscle Beats

    • Surgery
      Magnetic Dressing Improves Diabetic Wound Healing

      Magnetic Dressing Improves Diabetic Wound Healing

      Sensor Monitors Transplanted Organs for Signs of Rejection

      Sensor Monitors Transplanted Organs for Signs of Rejection

      Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

      Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

      Droplet Battery Harnesses Ionic Gradients for Bioelectronic Implants

      Droplet Battery Harnesses Ionic Gradients for Bioelectronic Implants

    • Nanomedicine
      Nanorobots Release Reactive Oxygen Species to Kill Fungal Biofilms

      Nanorobots Release Reactive Oxygen Species to Kill Fungal Biofilms

      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Get Lymphatic Vessels Pumping

      Nanoparticles Get Lymphatic Vessels Pumping

    • Military Medicine
      Wearable Can Take Multiple Sweat Samples

      Wearable Can Take Multiple Sweat Samples

      Wound Dressing Detects Infection, Changes Color

      Wound Dressing Detects Infection, Changes Color

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fingertip Sensor Measures Lithium Levels in Sweat

    • Rehab
      Stretchable E-Skin for Robotic Prostheses

      Stretchable E-Skin for Robotic Prostheses

      Glasses Provide Audible Prompts for Blind Wearers

      Glasses Provide Audible Prompts for Blind Wearers

      A Wearable to Manage Parkinson’s Motor Symptoms: Interview with Lucy Jung, CEO at Charco Neurotech

      A Wearable to Manage Parkinson’s Motor Symptoms: Interview with Lucy Jung, CEO at Charco Neurotech

      Robotic Ankle Helps with Postural Control in Amputees

      Robotic Ankle Helps with Postural Control in Amputees

  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Log in
  • Submit PR
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS

Abiomed Reports New Positive Impella 2.5 Results

September 24th, 2009 Medgadget Editors Cardiac Surgery, Cardiology


The latest results from trials examining Abiomed‘s Impella 2.5 Percutaneous Circulatory Support System, the world’s smallest left ventricle heart pump, are in, and they give the company, us and hoping clinicians a happy feeling. The big hurdle that the company has to overcome is to convince cardiologists that Impella devices are easy to place under difficult circumstances (such as developing high-risk PCI, MI in cath lab, failing ventricle), and are safe for patients. Also, Abiomed has to prove to cardiologists that Impella provides a clinical advantage versus intraaortic balloon pumps (IABP), when a patient’s heart is failing and needs an emergency ventricular support in the cath lab. On both of these points, it seems the company scored positive results in the latest trials.
From Abiomed’s press office:

USpella [is] the first U.S. multicenter registry of Impella 2.5 patients evaluating the safety and feasibility of left ventricular support with the Impella 2.5 during high-risk percutaneous coronary intervention (PCI) and treatment of acute myocardial infarction (AMI).
High-Risk PCI patient results in USpella

  • In 64% of the high-risk PCI cases, the patients had been turned down for CABG before treated with Impella 2.5
  • The high-risk PCI population presented with a more complex anatomy than the SYNTAX trial population (of 23), decreasing SYNTAX score from 38 to 18 after effective revascularization with Impella 2.5
  • Registry results reaffirmed ejection fraction increases that were similar to PROTECT I results, with improved ejection fraction in USpella high-risk PCI patients increasing from 29 to 34, after Impella 2.5 support
  • Reported overall MACE was low at 6%
  • 30-day survival rate was 97%
  • AMI patient results in USpella

  • Impella was used after conventional therapies failed, (88% after emergent revascularization; 88% after high-dose inotropes; 68% after IABP therapy
  • Impella improved hemodynamics in AMI shock patients, improving cardiac index from 1.9 to 2.5 l/min/m2, increasing mean arterial pressure from 62 to 87 mmHg, and decreasing wedge pressure from 28 to 20 mmHg, as well as decreasing overall Systemic Vascular Resistance (SVR)
  • After Impella 2.5 support, overall ejection fraction in AMI patients improved from 29 to 37%;
  • Impella successfully supported AMI refractory shock patients with 69% survival to the next therapy or onto recovery. Also, 58% of AMI shock patients and 89% of AMI patients with no shock were discharged
  • The MACH II trial, evaluating safety and feasibility in STEMI, included 20 patients; ten patients were treated with three days of Impella 2.5 support; ten control patients were treated with routine standard of care. The initial four-month results, which demonstrated significant recovery of left ventricular function in Impella 2.5 patients, were published in the Journal of American College of Cardiology in 2008.
    All patients were measured in an IRB-approved protocol that calculated echo results, exercise testing and quality of life, and showed the following results from core laboratory analysis and strict processes:

  • Left ventricular ejection fraction in Impella 2.5 patients increased from 28% at the baseline, to 41% in the four-month analysis, to 51% at the three-year follow-up period. Left ventricular ejection fraction in the control patients increased from 40% at the baseline, to 45% after the four-month analysis to 47% at the three year analysis. Impella 2.5 patients continued to show improvement in left ventricular ejection fraction, demonstrating a net increase of 23 ejection fraction points while control patients only showed a net increase of 7 ejection fraction points.
  • Significant benefit in exercise capacity was demonstrated stronger by Impella 2.5 patients, than control patients, which also improves the quality of life for the patient
  • Impella 2.5 patients saw no effects on aortic valve at three-year follow-up
  • Press releases: Abiomed Presents Results from USpella; First U.S. Registry Data Evaluating 181 Patients from 16 Centers with IRB Approval…; Abiomed Reports Results from Academic Medical Center’s Three-Year Follow-up of MACH II Trial…
    More thoughts from MassDevice…
    Flashbacks: Impella 2.5 Heart Pump Performs Well in a Feasibility Trial; FDA OK’es Impella 5.0 and Impella LD Circulatory Assist Devices; Impella 2.5 Heart Pump Given Green Light in US; Impella Percutaneous VAD to be Studied for Acute MI Patients; impella® recover LV

    Medgadget Editors

    Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

    Sponsored
    Ark Surgical Performs First Hysterectomies in the USA with its FDA-Cleared LapBox for Manual Morcellation

    Ark Surgical Performs First Hysterectomies in the USA with its FDA-Cleared LapBox for Manual Morcellation

    PACKAGING COMPLIANCE LABS WELCOMES NEW CFO, BERNADETTE LEGARETTA

    PACKAGING COMPLIANCE LABS WELCOMES JENN GOFF, VP SALES, MARKETING, AND INNOVATION

    Clarius Debuts its First Dual-Array Wireless Handheld Scanner Enabling Whole-Body Views of Superficial to Deep Anatomy

    Clarius Debuts its First Dual-Array Wireless Handheld Scanner Enabling Whole-Body Views of Superficial to Deep Anatomy

    National Liver Health Awareness Month Highlights the Urgent Need for Liver Disease Prevention

    National Liver Health Awareness Month Highlights the Urgent Need for Liver Disease Prevention

    interviews & reviews
    A Wearable to Manage Parkinson’s Motor Symptoms: Interview with Lucy Jung, CEO at Charco Neurotech

    A Wearable to Manage Parkinson’s Motor Symptoms: Interview with Lucy Jung, CEO at Charco Neurotech

    Eko’s Newest CORE 500 Stethoscope: A Review

    Eko’s Newest CORE 500 Stethoscope: A Review

    Shear-Thinning Biomaterial for Embolic Applications: Interview with Upma Sharma, President and CEO of Arsenal Medical

    Shear-Thinning Biomaterial for Embolic Applications: Interview with Upma Sharma, President and CEO of Arsenal Medical

    Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

    Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

    UV-Free Air Decontamination: Interview with Sorel Rothschild, VP at Quantum Innovations

    UV-Free Air Decontamination: Interview with Sorel Rothschild, VP at Quantum Innovations

    EarliPoint Evaluation System for ASD Diagnosis: Interview with Tom Ressemann, CEO of EarliTec Dx

    EarliPoint Evaluation System for ASD Diagnosis: Interview with Tom Ressemann, CEO of EarliTec Dx

    Visually Guided Uterine Biopsies in Physician’s Office: Interview with Allison London Brown, CEO of LUMINELLE

    Visually Guided Uterine Biopsies in Physician’s Office: Interview with Allison London Brown, CEO of LUMINELLE

    • Subscribe
    • Contact us
    • Submit
    • About
    • Back to top
    Medgadget

    Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

    • About
    • Editorial policies
    • Contact
    • Terms of Service
    • Privacy
    • Submit press release
    • Advertise
    © Medgadget, Inc. All rights reserved. | The Medical Revolution Will Be Blogged.
    Please support this website by adding us to your whitelist in your ad blocker. Ads are what helps us bring you premium content! Thank you!