Key Points of Endovascular Procedures and Devices in 2023:
FDA Actions:
- Lifted restrictions on paclitaxel-coated balloons and stents for PAD after updated data showed no increased mortality risk.
- Approved coverage of carotid artery stenting for Medicare beneficiaries with severe stenosis.
- Approved the LimFlow device for diverting blood flow in severe CLTI patients, offering limb salvage hope.
- Approved the Paradise and Symplicity Spyral systems as the first renal denervation devices in the US.
CLTI Debate:
- Conflicting data from the BEST-CLI (surgery preferred) and BASIL-2 (endovascular preferred) trials emphasize patient-specific treatment decisions.
Other Developments:
- LIFE-BTK trial showed promising results for a new resorbable scaffold in below-the-knee interventions.
- PEERLESS II, HI-PEITHO, and STORM-PE trials are investigating advanced therapies for pulmonary embolism.
Future Outlook:
- The endovascular field is poised for continued innovation with new technologies and ongoing research.
- There is a need for operator training and reimbursement clarity for novel techniques like renal denervation.
- Upcoming PE trials are expected to provide level 1 evidence for improved treatment options.
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