Renal Denervation Round 2: Medtronic, Boston Sci Move Ahead With Studies
This article was originally published in The Gray Sheet
Medtronic and Boston Scientific are getting set to launch new trials of their renal denervation technologies, both believing they can overcome the problems that caused Medtronic's SYMPLICITY HTN-3 sham-controlled trial to miss its primary endpoint last year.
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Medtronic is re-upping its investments into renal denervation to treat hypertension after interim results were positive from a study testing the device procedure in patients not taking antihypertensive drugs. The firm announced it is launching a new pivotal study, more than three-and-a-half years after its last pivotal trial in the space failed.
Results of the CASTLE AF trial, comparing catheter ablation to conventional treatment in patients with left-ventricular dysfunction and atrial fibrillation, could boost demand for atrial fibrillation ablation devices. That data will be presented at the European Society of Cardiology congress on August 27, also featuring the results of REVEAL AF, a trial of minimally invasive prolonged electrographic monitoring for AF. Also, results from the SPYRAL HTN OFF-MED may show if renal denervation has a future as a treatment for hypertension
Medtronic Marches Ahead In Renal Denervation; Announces Symplicity’s Inclusion In US Parallel Review Program
Medtronic’s Symplicity renal denervation system has won entrance into an elite group – it is one of the first devices to be selected for the joint FDA/CMS parallel review program, launched in 2011. That distinction could help the company quickly move the device into US clinical practice once it’s FDA approved.