May 2026 Boston Scientific received a U.S. FDA PMA supplement approval for the Innova™ Vascular Self-Expanding Stent System. The approval covered a manufacturing process update related to the device, supporting continued commercial availability of the self-expanding peripheral vascular stent system.
April 2026 Medtronic received FDA approval for a PMA supplement related to its Abre™ Venous Self-expanding Stent System. The supplement approved an additional repacking site and minor packaging process modifications for the iliac vein stent system.
October 2025 Boston Scientific received FDA approval for a PMA supplement for the Innova™ Vascular Self-Expanding Stent System. The approval involved a manufacturing process modification related to reducing rinse steps during the electropolishing process of the stent system.
September 2025 Medtronic received FDA approval for a PMA supplement for the Abre™ Venous Self-expanding Stent System. The update involved modifications to catheter assembly equipment process parameters for the venous stent system.