• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA panel to mull St. Jude Medical’s Amplatzer PFO occluder cardiac implant

FDA panel to mull St. Jude Medical’s Amplatzer PFO occluder cardiac implant

April 13, 2016 By Brad Perriello

St. Jude Medical's Amplatzer PFO occluderAn FDA advisory panel is slated to review the clinical data behind St. Jude Medical‘s (NYSE:STJ) bid for pre-market approval of its Amplatzer cardiac implant for treating patent foramen ovale.

The FDA’s Circulatory System Devices Panel is due to convene May 24 for a hearing on the Amplatzer PFO device,  a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke.

Back in October 2012, the Amplatzer PFO device failed to meet the primary endpoint in a 980-patient clinical trial comparing it with drug therapy in patients with recurrent cryptogenic stroke and PFO. The Respect study showed that 9 patients in the Amplatzer arm suffered non-fatal strokes, compared with 16 in the drug treatment cohort, a non-statistically significant reduction of 50.8%.

St. Jude said at the time that a quirk in the study’s design meant that 3 of the Amplatzer patients were never actually implanted iwth the device. Excluding those patients, and patients in the drug treatment cohort who dropped drug therapy, and the risk of stroke in the Amplatzer arm fell to 63%. And later analyses showed a “magnification” of benefits when 24 non-implanted patients were taken out of the Amplatzer arm and fewer and smaller strokes than patients who received drug therapy alone.

Little Canada, Minn.-based St. Jude bought its Amplatzer technology, along with AGA Medical, for $1.03 billion in 2010.

Filed Under: Cardiac Implants, Clinical Trials, Food & Drug Administration (FDA) Tagged With: stjudemedical

More recent news

  • Data backs DermaSensor skin cancer detection device
  • GE HealthCare expands digital imaging portfolio with enhanced MIM Encore software
  • Accelus wins FDA clearance for MRI compatibility of FlareHawk spinal implants
  • Presidio wins FDA IDE for ultra-low frequency neuromod, hires new CFO
  • Epiminder study backs implantable EEG tech

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock 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.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. 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.

Privacy Policy