First patient procedure using new shield surface modification was performed at the NYU Langone Health in New York City


Pipeline Flex embolisation device features a braided cylindrical mesh tube. (Credit: Raman Oza from Pixabay)

Medtronic has received the US Food and Drug Administration (FDA) approval for Pipeline Flex embolisation device with Shield Technology.

Shield Technology is developed to advance flow diversion therapy with the introduction of a surface-modified implant device that reduces material thrombogenicity.

Material thrombogenicity is defined as reduction in tendency of the surface treatment material in creating blood clots.

The first patient procedure in the US, using the new embolisation device was performed at the NYU Langone Health in New York City.

Pipeline Flex device diverts blood flow away from aneurysm

The Pipeline Flex embolisation device features a braided cylindrical mesh tube that is implanted across the base, or neck, of the aneurysm, to divert the blood flow away from it.

The device works to reconstruct the diseased section of the parent vessel, by interrupting blood flow into the aneurysm.

In the pre-clinical tests, Shield Technology was shown to have improved Pipeline Flex by reducing the thrombogenicity of the device material.

Also, results from the SHIELD Study showed that the third-generation embolisation device with Shield Technology offered superior safety and efficacy of flow diversion therapy with the Medtronic products.

The Pipeline embolisation device has been used to treat patients in the US since 2011 and the company is currently offering the device with Shield Technology.

Medtronic claimed that its Pipeline Flex embolisation device is the first commercially available flow diverter in the US market.

Medtronic neurovascular business president Dan Volz 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.

“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.”

In March, the company received FDA approval for its Harmony transcatheter pulmonary valve (TPV) system to treat patients with congenital heart disease.