Medtronic (NYSE:MDT) announced today that it received FDA approval for its Pipeline Flex embolization device with Shield Technology.
Fridley, Minn.–based Medtronic’s Shield Technology is a proprietary platform designed to advance flow diversion therapy through a surface-modified implant device that demonstrates a reduction in material thrombogenicity — a reduction in the tendency of the surface treatment material to create clots — according to a news release.
New York City-based NYU Langone Health performed the first patient procedure in the U.S. with the newly cleared Pipeline Flex device with Shield Technology.
Pipeline Flex, which has been on the market for close to 10 years in the U.S., is a device designed to divert blood flow away from a brain aneurysm. A braided, cylindrical mesh tube is implanted across the base or neck of the aneurysm. It interrupts blood flow into the aneurysm and reconstructs the diseased section of the parent vessel.
Data from the SHIELD study, published in the Journal of NeuroInterventional Surgery (JNIS) in June 2020, demonstrated that the device with Shield Technology demonstrated strong safety and efficacy of flow diversion therapy with the Medtronic family of products, the company said.
“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,” Medtronic neurovascular business president Dan Volz said in the release. ”
Ten years ago, Medtronic changed the treatment paradigm in brain aneurysms with the approval of Pipeline Embolization Device, and we continue to challenge ourselves to deliver solutions that improve outcomes and increase value for all healthcare stakeholders.”