Boston Scientific's TAVR Pipeline Delayed; FDA Approval Of Acurate neo2 Set For 2024
The SCOPE II results could have helped support a PMA for Acurate neo2 in 2021, but the trial missed its primary endpoint, and the REPRISE IV trial of Boston Scientific's Lotus Edge TAVR system has been delayed by COVID-19.
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The company is recalling all unused Lotus Edge inventory and will stop developing the Lotus platform while shifting resources to support its Acurate neo2 transcatheter aortic valve system. The decision will cost the company up to $300m.
Boston Scientific’s management believes the ongoing recovery of procedure volumes and new technology will allow it to show revenue growth in the fourth quarter.
The FAST 01 feasibility trial is evaluating a modification to Varian’s ProBeam particle accelerator that enables ultra-high dose radiation to treat cancer.