Innovations Driven By Clinical Evidence

Volume 3 Issue 1
Article Information

Abstract

The Pipeline Embolization Device (PED) has become a routine first-line interventional option for treatment of intracranial aneurysms; however, thromboembolic complications are the main adverse events with flow diversion interventional procedures. A new, third generation version of the PED, the Pipeline Flex™ Embolization Device with Shield Technology™ (PFEDST), is now available with a surface modification that includes, phosphorylcholine, a synthetic biocompatible polymer. In vitro investigations show reduced thrombogenicity with this device compared with earlier devices. Preliminary clinical evaluation showed deployment was technically successful with 98% of implanted PFEDST devices, and no major strokes or neurologic deaths were reported in the 30-day post-procedure period. The sizing decision on the dimensions of a device chosen to treat intracranial aneurysms is crucially important, as the dimensions and characteristics of the device can change radically during deployment. SIM&SIZE™ simulation software allows interventional neurologists to perform a simulated device sizing, to confirm whether the device dimensions initially chosen are optimal for the treatment of the aneurysm and vessels under consideration.The clinical impact of simulated device sizing is significant; it has led to the use of shorter PEDs, and has reduced the requirement for secondary device implants.Medtronic have recently initiated INSPIRE; this is an observational, prospective, multi-centre, single-arm registry established to provide continuing evaluation and periodic reporting of the safety and effectiveness of Medtronic neurovascular implant devices used in the treatment of intracranial aneurysms.The aim of this registry is to collect performance and safety data on up to 10,000 patients and will monitor existing and forthcoming implant devices over their complete life cycles.

Key words: intracranial aneurysms, Pipeline Flex Embolization Device, phosphorylcholine, simulation software, SIM&SIZE,INSPIRE.

Acknowledgements: The editorial assistance of Mr Rob Goodwin, Oruen Ltd, in the preparation of this article is acknowledged with thanks.