Key Points from PROMISE 2 Trial:

• Problem: 20% of CLTI patients have no revascularization options, leading to amputations.

• Solution: Transcatheter arterialization of deep veins creates an artery-to-vein connection, delivering oxygenated blood to the ischemic foot and potentially preventing amputation.

• Study: Analyzed 105 patients with no other treatment options who underwent the procedure with LimFlow Device.

• Results:

o Amputation-free survival at 6 months: 66.1%, exceeding the 54% performance goal.

o Limb salvage: 76.0%.

o Wound healing: 25% completely healed, 51% in progress.

o Safety: No unanticipated device-related adverse events.

• Conclusion: Deep-vein arterialization is a safe and effective option for no-option CLTI patients, offering limb salvage, wound healing, and improved survival.

Article Link: DOI: 10.1056/NEJMoa2212754

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