DISRUPT PAD III OBSERVATIONAL STUDY

Design
Objective

Assess 'real-world' peri-procedural outcomes of IVL for treatment of calcified, stenotic, peripheral arteries

Design

Prospective, Multicenter, Single-Blind, Observational Study

Key Inclusion

RC 2-6
Moderate-severe calcification*
Ilio-femoral, femoral, popliteal and infrapopliteal arteries

1,373
Patients
1,677
Lesions
30
Sites
3
Countries

* Presence of fluoroscopic evidence of calcification by PARC definition: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length

Armstrong E, VIVA Late Breaking Clinical Trial 2022

Complex Real-World Patients and Lesions

Complex Patients
paitents icon
1,373 Patients
36%
CLI Patients
56%
Diabetes Mellitus
27%
Renal Insufficiency
Challenging Lesions
lesions icon
1,531 Lesions
90%
Mod-Severe CA++
115mm
Avg. Calcified Length
31%
CTOs

PARC Definition

Armstrong E, VIVA Late Breaking Clinical Trial 2022

Predictable Outcomes in Challenging Situations

Predictably consistent results across vessel beds,
challenging lesions and complex patients

chart demonstrating the consistent efficacy of IVL

Armstrong E, Late Breaking Clinical Trial and Shockwave-Sponsored Symposium, VIVA 2022

IVL Procedural Insights

Use of adjunctive technology was at the operator’s discretion – use of embolic protection was less when IVL was used as the only calcium modification tool; IVL saw better results with appropriate IVL sizing

When IVL was used as the only calcium modification therapy*, there was less use of embolic protection

1.3% Embolic protection when IVL was used without adjunctive Ca modifying therapy 1.3% embolic protection when IVL was used without adjunctive therapy
vs.
20% Embolic protection when IVL was used with adjunctive Ca modifying therapy 20% embolic protection when IVL was used with adjunctive therapy

Per a multivariable analysis, proper IVL balloon sizing (≥ 1:1)† is an independent predictor of improved stenosis reduction but not a predictor of complications.

IVL Balloon to Artery Ratio
IVL balloon to artery ratio
vs.
IVL balloon to artery ratio

* Ca modifying therapy: atherectomy and/or scoring/cutting balloon

PAD OS data analysis is consistent with prior PAD II data analysis and continues to support 1.1:1 sizing in the product instructions for use (IFU)

Armstrong E, VIVA Late Breaking Clinical Trial 2022

Real-World Outcomes Consistent with Randomized Trial

IVL safely and effectively modifies calcium across multiple vessel beds

Exceptional SAFETY Profile

chart demonstrating DISRUPT PAD III exceptional safety profile

1 Tepe et al, J Am Coll Cardiol Intv 2021

2 E. Armstrong, VIVA Late Breaking Clinical Trial 2022

Proven EFFECTIVE
Calcium Modification

chart demonstrating DISRUPT PAD III effective calcium modification
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On The +Plus Side

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