Last week, Medtronic disclosed in its quarterly report that it planned to submit to the FDA its application for an investigational device exemption for its next-generation renal denervation device. The spiral-shaped device has multiple electrodes and is designed to achieve more comprehensive ablation of the renal arteries. The company is seeking FDA approval to proceed with a phase II trial.
In its quarterly report, Boston Scientific said it plans to begin enrolling patients in the first half of this year in a phase II trial, REDUCE-HTN REINFORCE, testing its Vessix platform.
Background: NEJM Journal Watch General Medicine summary on SYMPLICITY HTN-3