Skip to main content

What is

Below the knee
chronic limb-threatening ischemia (CLTI)?

Chronic Limb Threatening Ischemia (CLTI) is a severe condition characterized by inadequate blood supply to the lower extremities due to advanced peripheral artery disease (PAD). It results in persistent ischemic rest pain, ulcers, or gangrene, threatening limb viability.

Reduced blood flow can have severe consequences.

Rest Pain

Ulcers and Non-Healing Wounds

Gangrene

25% of CLTI patients face an amputation.

Rising CLTI cases put a lot of pressure on healthcare systems

The associated economic burden of CLTI-related amputations is significant, with estimated lifetime direct healthcare costs of over $640k per amputated patient in the US.

3.5 M

CLTI patients in EU and US

250K

CLTI-related amputations in EU and US each year

+200%

Cost of amputation vs. limb-saving procedure

>$640K

Lifetime cost for CLTI patient after amputation in the US

Current standard of care:
Balloon angioplasty not effective for CLTI.

82%

Restenosis rate at 12 mos

48%

Reintervention rate at 12 mos

12%

Mortality rate at 12 mos

Our Solution

The Resorbable Fibrillated Scaffold (RFS) System

Resorbable

The RFS is designed to resorb fully within 12 months.

Strut-less design

The RFS is designed to have a smooth surface that allows for laminar blood flow through the scaffold.

Non-drug eluting

Due to the regenerative capacity of the RFS there is no need for an anti-restenotic drug to counteract progressive neointimal hyperplasia.

Catheter length

The RFS delivery system has a catheter shaft length of 150 cm.

Delivery System

The RFS is pre-mounted on a 0.014” Over-the-Wire (OTW) balloon-expandable delivery system.