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
UsernamePublicRestriction

Commercial Launch Of Fully Bioabsorbable Stent Still Several Years Out

This article was originally published in The Gray Sheet

Executive Summary

Abbott Vascular says it will approach FDA to design a U.S. clinical trial for its bioabsorbable everolimus-eluting stent once it gets data from a few hundred more patients in its overseas trials

You may also be interested in...



Cardio Device Makers Seek Clarity On Trials For Novel Combination Products

Device makers at the recent Cardiovascular Research Technologies (CRT) meeting in Washington, D.C., heard detailed tips - if not formal guidance - from FDA on how to plan pre-approval trials for drug-coated balloons, bioabsorbable stents and other novel combination products

Cardio Device Makers Seek Clarity On Trials For Novel Combination Products

Device makers at the recent Cardiovascular Research Technologies (CRT) meeting in Washington, D.C., heard detailed tips - if not formal guidance - from FDA on how to plan pre-approval trials for drug-coated balloons, bioabsorbable stents and other novel combination products

AHA In Brief

Medtronic PACE trial: Patients who received biventricular pacing with Medtronic's InSync III cardiac resynchronization therapy pacemaker (CRT-P) had no change in ejection fraction after one year, compared to a 6.8% reduction in ejection fraction for patients receiving right ventricular pacing alone, according to results of the Pacing to Avoid Cardiac Enlargement (PACE) trial presented Nov. 15 at the American Heart Association Scientific Sessions in Orlando. The data, which include 177 patients, were published online the same day in the New England Journal of Medicine. In addition, patients in the biventricular pacing group had no change in left ventricular size, while the right ventricular pacing arm saw a significant increase of 6.3 mL on average. Medtronic is also conducting the randomized, double-blind BLOCK-HF trial comparing biventricular and right ventricular pacing in heart failure patients with atrioventricular block; data on primary outcome measures are expected in late 2012. Biventricular pacing is currently not approved for pacemaker patients with normal pumping hearts, Medtronic notes

Topics

UsernamePublicRestriction

Register

SC143429

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