May 19, 2020
Two-Year ALPS Registry Outcomes Published for LimFlow pDVA System
May 19, 2020—LimFlow SA announced the publication of 2-year data from the ALPS Registry of the LimFlow percutaneous deep vein arterialization (pDVA) system. The ALPS registry is seeking mid- and long-term results in no-option chronic limb-threatening ischemia (CLTI) patients treated with the LimFlow system. The results were published by Andrej Schmidt, MD, et al online ahead of print in the August edition of the Journal of Endovascular Therapy.
The multicenter, retrospective study was conducted at centers in Alkmaar, the Netherlands; Leipzig, Germany; Paris, France; and Singapore. It is composed of 32 endstage—“no-option”—CLTI patients, of whom 66% had diabetes, 53% had renal insufficiency, and 16% were dialysis-dependent. All patients had nonhealing wounds on the target foot and no arterial target for surgical or endovascular revascularization. Most patients had experienced failed previous attempts at revascularization.
According to LimFlow, the registry reported major amputation-free survival of 84%, 71%, and 67%, respectively, at 6 months, 1, and 2 years. Additionally, a positive trend of successful wound healing was demonstrated, with 73% of wounds completely healed at 2 years. The technical success was 97%.
“In this complex group of patients, pDVA using the LimFlow device has shown to be feasible and safe with high technical success and good amputation-free survival at 6 months up to 24 months coupled with good wound healing,” commented Dr. Schmidt in the company's announcement. “In selected patients with no-option CLTI, pDVA is a safe and effective treatment to prevent amputation and heal wounds.”
Coinvestigator Roberto Ferraresi, MD, added, “Patients with this disease suffer from chronic ulcers, often including gangrene, recurrent pain, and a very poor quality of life. CLTI is associated with poor mid- and long-term survival and no-option patients often face the worst outcomes. These patients desperately need an option to avoid amputation and improve their lives, and LimFlow offers a very promising alternative for them.”
The LimFlow system received European CE Mark approval in 2016. The device has not been approved for sale in the United States, Canada, or Japan. The LimFlow technology is approved for investigational use only in the United States, advised the company.