A proof-of-concept and safety study of the LimFlow System has been carried out in Changi General Hospital in Singapore. This pilot, prospective, open-label, single-center, single-arm study included seven independently-assessed, end-stage CLI patients with no remaining conventional surgical or endovascular options. Patients were enrolled between September 2013 and November 2014. The study results were published at the Journal of Endovascular Therapy (JEVT) in July 2017.
7 Patients, No-option CLTI
Average age: 85 years old
*WIfI Wound Ischemia Foot Infection
**MALE (Major Adverse Limb Event) defined as major amputation or major surgical intervention on index limb
LimFlow Clinical Results
Figure 1: Pre- and Post-procedure angiograms in pilot study