DEPENDABLE SOLUTIONS
FOR DIFFICULT SCENARIOS

Clinical Evidence RESTOR-1 Study1

AngioSafe’s Atheroplasty™ platform is backed by rigorous clinical evaluation. Designed to enable safe, efficient, and wire-free crossing of complex CTOs.

RESTOR-1 Pivotal Trial:

A prospective, multi center, pivotal study, conducted at 14 sites in the United States with 74 patients enrolled, treated and core-lab adjudicated.

Objective:

To demonstrate the safety and effectiveness of the Santreva-ATK System to facilitate crossing of CTOs in the peripheral vasculature.

Key Inclusion Criteria:

  • Rutherford Classification Criteria 2-5
  • Femoropopliteal arteries
  • 99-100% stenosed
  • Max 300mm long, regardless of calcium severity

Primary Endpoint:

Clinical success of Santreva-ATK to facilitate placement of guidewire into the distal true lumen of the femoropopliteal artery CTO, in the absence of device-related major adverse events (MAE) through discharge or 24 hours post-procedure, whichever is sooner.

AngioSafe delivers compelling
results where it matters most.

0 %
Overall Success
> 0 %
Mean Lumen Gain2
0
Device-Related MAEs
0
Embolization
0
Major Perforation
0
Flow-limiting Dissections
Or Bailout Stent
0
Mean Crossing

Time (min)
0
Median Crossing

Time (min)
0
Mean Lesion

Length (mm)

Built to perform where patient and
lesion complexity converge

0 %
Of Successful Cases Were
Crossed Antegrade Only
> 0 %
Of Successful Case Crossing
Was Completed Intraluminal
~ 0 %
Single Access Only

Breakthrough performance that goes beyond crossing

>55% lumen gain and a ~6.5mm2 average cross sectional area following Santreva-ATK crossing only2

Santreva-ATK performs both crossing and lumen revascularization.

Bar chart showing Santreva-ATK's lumen gain (54-60%) across various calcification severities, confirming vessel opening.

Traditional CTO procedures rely on multiple devices to cross, then open the vessel. Our technology merges those steps — delivering a more efficient, streamlined experience with the potential to reduce complications, reduce procedure times, and improve outcomes.

Bar chart showing AngioSafe Santreva ATK Atheroplasty results for 74 CTOs, with 100% baseline stenosis, 43% residual stenosis, and 57% luminal gain following atheroplasty.

Significant Improvement in Rutherford Classification and Pain Scores

Bar charts showing significant improvement in Rutherford Classification and Pain Scores from baseline to 30-day follow-up (n=54). The mean Rutherford score decreased from 3.4 at baseline to 1.25 at 30 days, and the mean pain numeric rating decreased from 5.24 at baseline to 2.06 at 30 days.

From Proximal Cap to True Lumen
Introducing Santreva-ATK

Santreva-ATK is an all-in-one, large-profile, manually controlled, and guidewire-free endovascular CTO crossing solution, with full force range and control to tackle the wide range of plaque morphologies, designed to limit damage to the vessel wall.

Explore Santreva-ATK

1RESTOR-1 Pivotal Clinical Study, data on file and Instructions for Use (IFU)
2Post hoc analysis of prospectively collected data, as assessed by the core lab: data on file with company