LimFlow’s Percutaneous Deep Vein Arterialization System Studied for Cost-Effectiveness

July 28, 2021—LimFlow SA, a developer of minimally-invasive technology to treat chronic limb-threatening ischemia (CLTI), announced that health economic findings for the LimFlow percutaneous deep vein arterialization (pDVA) system were published by Jan B. Pietzsch, PhD, et al online ahead of print in Journal of Critical Limb Ischemia.

The LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins in patients with CLTI who are facing major amputation and have exhausted all other therapeutic options. LimFlow is based in Paris, France, and San Jose, California.

According to LimFlow, the study investigators found significant and promising data from their cost-effectiveness analysis comparing pDVA with the LimFlow system to the status quo treatment for no-option CLTI patients. The status quo was defined by a meta-analysis conducted by the Yale Cardiovascular Research Group on no-option patient outcomes from other reputable studies ranging from 2006 to 2018, which is pending publication in Journal of Critical Limb Ischemia.

The company stated that the comparative analysis demonstrated that expected outcome improvements with pDVA entirely justify its incremental costs and qualifies it as a “high-value” therapy per established willingness-to-pay thresholds. The study further utilized rigorous health-economic methodologies to expose the technology’s ability to positively impact the lives of patients who are currently underserved and that LimFlow can do so without overburdening the health care system.

“The cost-effectiveness analysis builds on recently published 12-month data from the PROMISE I study by showing that pDVA with the LimFlow system can be a high-value therapy alternative to the status quo for no-option CLTI patients,” commented study investigator Peter A. Schneider, MD in the company’s press release. “This research highlights the health economic benefits of reducing amputations and the need to offer patients a better alternative worldwide.”

Dr. Schneider is Professor of Surgery at the University of California, San Francisco, in San Francisco, California. Dr. Pietzsch is President and CEO of Wing Tech, Inc., an independent research firm conducting health economic analyses that received consulting fees from LimFlow SA to conduct the analyses underlying this study.

In May 2021, the company announced the publication of the 12-month data from the full patient cohort in its PROMISE I early feasibility study by Daniel G. Clair, MD, et al. The study is available online in Journal of Vascular Surgery.

Mary Yost, President, The Sage Group LLC, stated in LimFlow's announcement, “CLTI currently affects up to 3.8 million people in the United States and costs the health care system $200 to $300 billion in all-cause costs annually. More alarming than the costs and prevalence of CLTI is the mortality rate; more patients die within 5 years of a CLTI diagnosis than with any type of cancer except for lung cancer.”

The LimFlow technology is approved for investigational use only in the United States. The LimFlow system received CE Mark approval in October 2016 and is available commercially in Europe. The LimFlow system has not been approved for sale in the United States, Canada, or Japan, advised the company.