For CLTI patients who have lost blood flow below their knee and have no other suitable endovascular or surgical treatment options available, the LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is now the last resort to avoid amputation.
LimFlow’s TADV system won breakthrough device designation in October 2017 and secured FDA premarket approval (PMA) in September 2023.
“A lot of technologies come out of people fiddling with technologies that already exist, and then developing unique proprietary solutions after that,” LimFlow CEO Dan Rose said in an interview with Medical Design & Outsourcing. “That was kind of our journey. … We hope to break a logjam, which is the limits of [applying traditional] coronary technology below the knee by creating a new circuit that allows us to deliver the oxygenated blood these patients need.”
LimFlow’s minimally invasive procedure diverts blood around diseased arteries and into veins to restore blood flow into a patient’s ischemic foot.
TADV relieves ischemia by using veins to oxygenate tissue (essentially turning them into arteries), a relatively simple concept that goes back more than a century. But the risks of creating such a large surgical wound — including infection that could require amputation — have historically outweighed the benefits.
However, modern coronary and peripheral interventional medicine and the ever-growing use of catheters, wires, stents and balloons now allows surgeons to make small, precise punctures in the vasculature.
“How we actually did the first-in-man was saying, ‘How can we try to use just interventional techniques to accomplish the goal with a surgical procedure [using] off-the-shelf devices? And that was the beginning of LimFlow — using common tools to prove the principle,” Rose said.
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