Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Heart separation device improves 3 year outcomes in heart failure patients

August 27, 2012 By European Society of Cardiology

A novel non-invasive device which separates healthy and damaged heart muscle and restores ventricle function improves 3 year outcomes in patients with ischemic heart failure, according to research presented at the ESC Congress 2012. The findings were presented by Professor William T. Abraham at an ESC press conference on 25 August and by Dr Marco Costa at an ESC Congress scientific session on 27 August.

Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.

Many heart attack survivors experience enlargement of the heart, causing a decrease in cardiac output that results in heart failure symptoms such as fatigue and shortness of breath. The healthy portion of the heart not affected by the heart attack has to compensate for the loss in output and becomes overloaded over time. Current treatment options for patients whose hearts have enlarged are limited.

The Parachute Ventricular Partitioning Device is the first minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack. The Parachute device is implanted in the left ventricle through a small catheter inserted in the femoral artery.

“The device creates a barrier between the non-functioning, damaged segment of heart muscle and the healthy, functional segment of heart muscle,” said Dr Costa. “This decreases the overall volume of the left ventricle chamber and restores its optimal geometry and function. The procedure is performed in the catheterization laboratory under conscious sedation.”

Two-year clinical data presented at the EuroPCR conference earlier this year demonstrated improved overall cardiac function and quality of life for patients treated with the Parachute device.

The current study included 31patients treated in the US and Europe with the Parachute system. The New York Heart Association (NYHA) Functional Classification of 1 (mildest) to 4 (most severe) was used to define the severity of heart failure at 1, 2 and 3 years after treatment.

The average NYHA class at baseline was 2.6. This improved to 1.6 (p<0.001) at 1 year, 1.9 (p<0.01) at 2 years and 1.8 (p<0.0001) at 3 years post treatment. Dr Costa said: “This shows that the severity of heart failure maintained its improvement over time after treatment with the Parachute device.”

The proportion of patients who were hospitalized due to worsening heart failure increased from 29.7% at 2 years to 33.2% at 3 years after treatment. “This small increase could be because the Parachute is specifically targeting the structural heart problem by excluding the scar caused from a heart attack which initiated the negative ventricle remodeling,” said Dr Costa.

The low cardiac death rate of 6.5% at 2 years remained unchanged at 3 years. “This suggests that percutaneous ventricle restoration with the Parachute system results in a plateau of the progression of heart failure in these patients,” said Dr Costa. “These outcomes compare favorably with current medical therapy in a similar high-risk patient population.”

“These results are compelling,” said Professor Abraham. “The sustained improvements in functional capacity and plateauing effect seen in outcomes three years after treatment with the Parachute device are particularly encouraging, showing that we may be able to slow the progression of heart failure – a very exciting prospect.”

“We were already very excited about the two-year clinical data presented at the EuroPCR conference earlier this year,” said Dr Costa. “Our three-year results in this high-risk population reinforce our initial enthusiasm and fuel our motivation to start a large randomized trial later this year.”

Dr Costa concluded: “In these two first-in-man studies we have shown that the Parachute device is safe and leads to sustained improvements in symptoms, heart function, and clinical outcomes over three years. This points to a potentially historical turning point in the treatment of heart failure caused by a heart attack.”

Related Articles Read More >

CeQur Simplicity
CeQur is launching a discreet, convenient ‘wearable insulin pen’
Blackrock's Utah array is a miniature array of electrodes for sensing brain signals
Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
Engineer inspecting artificial hip joint parts in quality control department in orthopaedic factory
Deburring and finishing for beautiful, functional medical devices
A Medtronic HVAD pump opened up to show the inner workings
FDA designates new Medtronic HVAD pump implant recall as Class I

DeviceTalks Weekly.

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech