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

Saint Luke’s Mid America Heart Institute Clinical Trial To Investigate Effectiveness Of Cardiac Surgery Device

February 25, 2013 By PR Newswire

 

Clinical trial to determine if chest closure device leads to better bone healing following cardiac surgery

KANSAS CITY, Mo., Feb. 25, 2013 /PRNewswire-USNewswire/ — Patients undergoing open heart procedures such as coronary artery bypass or valve surgery may be eligible to enroll in a clinical trial available in the Kansas City area only at Saint Luke’s Mid America Heart Institute.

The SternaLock® Blu clinical trial will compare patients whose sternum (breastbone) is closed with conventional stainless steel wire to patients whose sternum is closed with Biomet’s SternaLock® Blu Primary Closure System to evaluate sternal bone healing following a full median sternotomy.

A median sternotomy is the incision typically used when performing an open heart procedure.  Following the procedure the breast plate is typically put back together with wires. The SternaLock closure uses plates and screws commonly used during orthopedic cases.  This study is designed to determine if one method of sternal closure results in better healing of the breastbone compared to the other and if there are differences in the amount of pain, the use of pain medication, and functional recovery following heart surgery between the two closure methods. More than 700,000 sternotomies are performed in the U.S. annually.

Outcomes in this trial will include bone healing, post-operative pain, analgesic usage, patient function, and quality of life, in addition to economic costs between wires and the SternaLock system.  

Keith Allen , M.D., director of surgical research and a cardiothoracic surgeon at Saint Luke’s Mid America Heart Institute, is the trial’s national principal investigator. The trial plans to enroll 236 patients from up to 12 leading cardiac centers in the U.S.

“The standard of care to date has been use of wires to close and stabilize the breastbone following cardiac surgery,” said Dr. Allen. “Previous research has shown improved bone healing and reduced post-operative pain in patients receiving a rigid fixation device following sternotomy. Saint Luke’s looks forward to contributing to the pioneering research into this new surgical option.”

Saint Luke’s enrolled its first patient on Feb. 8 with a patient who received an aortic valve replacement performed by J. Russell Davis , M.D. The 56-year-old man is healing well after surgery to correct a defective heart valve.

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