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
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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