U.S. FDA Approves Pipeline™ Flex Embolization Device with Shield Technology™

medtronic Pipeline with shield technology

Medtronic plc has received U.S. FDA approval for Pipeline™ Flex Embolization Device with Shield Technology™.

Background

An estimated 500,000 people throughout the world die each year due to ruptured brain aneurysms, with half the victims younger than 50 years of age. As the most studied flow diverter worldwide, Pipeline Embolization Device has been used to treat patients in the United States since 2011 and is now available with Medtronic’s Shield Technology.

Shield Technology is a proprietary breakthrough in biomaterial science, designed to advance flow diversion therapy by introducing the first surface-modified implant device to demonstrate reduction in material thrombogenicity. 

We first covered the Pipeline Flex system back in 2014 when it gained EU CE mark approval. Now celebrating its 10-year anniversary in the U.S., Pipeline Flex Embolization Device diverts blood flow away from a brain aneurysm. The first commercially available flow diverter in the market, the device features a braided cylindrical mesh tube that is implanted across the base, or neck, of the aneurysm. The device interrupts blood flow into the aneurysm, reconstructing the diseased section of the parent vessel. Pre-clinical testing shows how Shield Technology improves Pipeline Flex by reducing the thrombogenicity of the device material.

Clinician comments

“The Pipeline Flex-Shield that we used today at NYU Langone to treat a giant left internal carotid aneurysm, represents a pivotal milestone in the evolution of flow diversion therapy—establishing a new vanguard for safe and effective management of complex cerebral aneurysms,” said Peter Kim Nelson, M.D., chief of Interventional Neuroradiology and professor of Radiology and Neurosurgery at NYU Langone Health.

“Our team has long-anticipated the availability of this device for patients in the United States. The surface modification of the implant has demonstrated reduced material thrombogenicity,  discernably aiding delivery through tortuous vascular anatomy with improved delivery and resheathing forces compared to earlier generation flow diverters.”

Published on June 1, 2020, in the Journal of NeuroInterventional Surgery (JNIS), results from the SHIELD Study (Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study) demonstrate that the third-generation Pipeline Flex Embolization Device with Shield Technology showed 77.2% complete aneurysm occlusion at 12 months, a 3.2% primary safety endpoint, and 93.1% complete wall apposition post-procedure.

Company comments

Dan Volz, president of the Neurovascular business (part of the Neuroscience Portfolio at Medtronic) states; “Ten years ago, Medtronic changed the treatment paradigm in brain aneurysms with the approval of Pipeline Embolization Device. We continue to challenge ourselves to deliver solutions that improve outcomes and increase value for all healthcare stakeholders.”

“In addition to addressing material thrombogenicity, Shield Technology improves device performance by reducing the force required for both delivery and resheathing of the device. We believe that Shield Technology opens up a new range of options for physicians to continue to achieve improved patient outcomes.”

Source: Medtronic plc

Share your thoughts

Your email address will not be published.