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First-in-Human Study

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.

Patient Demographics

7 Patients, No-option CLTI

Average age: 85 years old

First-in-Man - Demographics | amCharts

First-in-Human Study Results – U.S.

*WIfI Wound Ischemia Foot Infection

Primary Endpoints1**

30-Day Outcomes

MALE**
Survival
Technical Success

**MALE (Major Adverse Limb Event) defined as major amputation or major surgical intervention on index limb

Secondary Endpoints1

Limb Salvage1

First-in-Man - Limb Salvage | amCharts

Wound Healing1

First-in-Man - Wound Healing | amCharts

Tissue Perfusion2

First-in-Man - Tissue Perfusion | amCharts

First-in-Human Study Results – U.S.
View First-in-Human Publication

LimFlow Clinical Results

Figure 1: Pre- and Post-procedure angiograms in pilot study

Before

First-in-Human Study Results – U.S.
First-in-Human Study Results – U.S.
First-in-Human Study Results – U.S.

Pre-LimFlow

After

First-in-Human Study Results – U.S.
First-in-Human Study Results – U.S.
First-in-Human Study Results – U.S.

34 Weeks Post-LimFlow

First-in-Human Study Results – U.S.

62 Weeks Post-LimFlow

1. Kum S, Tan YK, Schreve MA, Ferraresi R, Varcoe RL, Schmid A, et al. Midterm outcomes from a pilot study of percutaneous deep vein arterialization for the treatment of no-option critical limb ischemia. J Endovasc Ther. 2017 Jul 1:doi: 10.1177/1526602817719283 (epub ahead of print)
2. Median healing time 4.6 months (95% CI, 84-192d).Median healing time 4.6 months (95% CI, 84-192d).
* Minor complications: 2 non-ST, non-procedure related elevated MIs; 1 patient developed spontaneous retroperitoneal bleeding 8 weeks’ post-procedure and was managed conservatively after cessation of anticoagulation.
# 3 non-procedure related deaths within 12 months: 2 patients died of pneumonia at 6 and 8 months, respectively; 1 patient had a fatal MI at 7 months following above-the-knee amputation.