FDA approves Medtronic's clot-resistant implant for stopping brain aneurysms

Ten years after first introducing its implant designed to divert blood flow away from a brain aneurysm and prevent its rupture, Medtronic has upgraded it with new materials that aim to prevent the formation of blood clots.

The transcatheter Pipeline Flex embolization device has received a new FDA approval to cover what the medtech giant calls Shield Technology: a chemically bonded, synthetic coating that helps camouflage the metal implant from blood cells and hide it from the body’s typical responses to an invading object.

The coating also makes the device slipperier, allowing it to more easily slide through curving vasculature during placement and deploy with less force compared to earlier generations. Initial clinical data have shown zero major strokes in the arteries downstream from the implant site as well as no recurrence of the aneurysm itself, according to the company. 

Made of braided metal alloy, the meshlike Pipeline Flex device constructs a new corridor for the blood to flow through at the base of an aneurysm, when the walls of an artery swell outward like a balloon. As the pressure eases, the vessel begins to reform its original shape.

The Pipeline Flex system (Medtronic)

RELATED: FDA approves Medtronic device for sealing off deeper, smaller brain aneurysms

Medtronic describes the latest version as the first surface-modified implant to show reductions in thrombogenicity, or the tendency for a material to create blood clots. The device’s first patient underwent treatment at NYU Langone Health.

“We believe that Shield Technology opens up a new range of options for physicians to continue to achieve improved patient outcomes," Dan Volz, president of Medtronic’s neurovascular business, said in a statement.

RELATED: Medtronic's drug-coated balloon for dialysis fistulas clears study

Earlier this week, Medtronic also presented two-year clinical data for its IN.PACT AV drug-coated balloon designed to reopen the vessels used as dialysis access ports for patients with end-stage renal disease. 

These surgically grafted vessels, known as arteriovenous fistulae, help maintain blood pressure and flow during hemodialysis and can collapse multiple times over the course of a year.

The IN.PACT balloon kept those vessels open longer during the clinical study compared to standard angioplasty, with target patency being maintained for 24 months in 52% of patients versus 36%. Previously, six-month data showed vessels remaining open in 86.1% of treated patients, compared to 68.9% in the control group.