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Abbott’s Navitor TAVI System Receives European CE Mark for Aortic Stenosis in Patients at Low or Intermediate-Risk for Surgery

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  • Abbott has received the CE Mark approval for Navitor transcatheter aortic valve implantation(TAVI) system to expand its use in people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery
  • Approval was backed by VANTAGE study of Navitor TAVI, which met its safety & efficacy 1EPs in above pts
  • Trial showed no mod. or sev. PVL & only 13.6% mild PVL at 30 days, high technical success (97%) with no procedural deaths, & excellent hemodynamic performance at 12mos., plus it showed a low rate of all-cause mortality or fatal/stroke with disability (2.3%) in the first 262 pts with 12mos. follow-up; data presented at ESC’25 & published in The JACC: Cardiovascular Interventions

Ref: Abbott | Image: Abbott | Press Release

Related News:- Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee 

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