Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Panel: Heart Closure Device Safety Data Demands Further Study

This article was originally published in The Gray Sheet

Executive Summary

More study is required to make sense of the adverse event rates associated with two marketed atrial septal defect occluders, a May 24 FDA panel concluded. St. Jude Medical, in particular, should start a new prospective study for its Amplatzer device, the panel recommends.

You may also be interested in...



Case Closed On PFO Closure? A Principal Investigator Weighs In

Future prospects for devices that close patent foramen ovale heart defects to prevent recurrent strokes remain in some doubt as researchers continue to mull recent data.

AGA Purchase Gives St. Jude Structural Heart Leadership, Growth Potential

St. Jude Medical will become the market leader in structural heart defect closure devices with its planned $1.3 billion purchase of AGA Medical.

Can Novo’s Oral Semaglutide Shake Up Indian Diabetes Segment?

Novo Nordisk's oral semaglutide debuts in India at a monthly cost of about $135 and promises to transform diabetes management in the country. Will it impact the SGLT-2 inhibitor class and potentially cannibalize injectable GLP-1 receptor agonists?

Topics

Related Companies

UsernamePublicRestriction

Register

MT031248

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel