Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device.

ABSTRACT:

Background

The use of flow diversion to treat intracranial aneurysms has increased in recent years.

Objective

To assess the safety and angiographic efficacy of the p64 flow modulation device.

Methods

Diversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3-6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography.

Results

A total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation

SUBMITTER: Bonafe A 

PROVIDER: S-EPMC9380510 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature