DISRUPT BTK II

Chandra V, Two-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2026.

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

Full Cohort Baseline Demographics

The DISRUPT BTK II study enrolled the largest cohort of real-world, complex patients with moderate to severe calcium below the knee; no other technology has been evaluated in such severely calcified BTK lesions to date. BTK II sets a new benchmark for what’s possible for these challenging lesions.

Medical History

*Enrollment of RC3 was capped at 20% | ^†PARC Definition
Armstrong E, One-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2025.

IVL’s Safety Profile Confirmed in Challenging Calcium Below the Knee

IVL was confirmed to be a safe treatment option in a challenging patient and lesion cohort. 

STRONG SAFETY PROFILE

Three patients with serious angiographic complications at final:  

• One patient had one undiagnosed minor perforation (Grade I)  
• One patient had a Grade II perforation seen pre-IVL balloon inflation, downgraded to Grade I after DES placement  
• One patient experienced abrupt vessel closure despite DES placement for grade F dissection  

None of the three patients had adverse events through discharge. 

1: One patient had a distal thromboembolism post-IVL. Transluminal suction thrombectomy was performed and the event was successfully resolved although imaging was not provided to the core lab for assessment, therefore, data was not included in table.
2: No Reflow defined as reduced antegrade flow without evidence of residual stenosis or dissection at the treatment site.
Chandra V, Lansky AJ, Sayfo S, et al. Thirty-Day Outcomes from the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee Peripheral Arterial Disease. Journal of Vascular Surgery. Published online November 12, 2024. doi:10.1016/j.jvs.2024.11.003

IVL’s Effectiveness Confirmed in Challenging Calcium Below the Knee

IVL was confirmed to be effective at reducing lesion stenosis with minimal additional treatment therapy. 

Primary Effectiveness Endpoint

• Final residual stenosis of ≤ 50% without serious angiographic complications: 97.9% (232/237, 95% CI 95.1%-99.3%)
• Additional analysis: Final residual stenosis of ≤ 30% without serious angiographic complications: 74.1% (215/290, 95% CI 68.7%-79.1%)

Chandra V, Lansky AJ, Sayfo S, et al. Thirty-Day Outcomes from the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee Peripheral Arterial Disease. Journal of Vascular Surgery. Published online November 12, 2024. doi:10.1016/j.jvs.2024.11.003

Procedural Information

*Remaining stent/tack implants were part of physicians’ standard algorithm.
Chandra V, Lansky AJ, Sayfo S, et al. Thirty-Day Outcomes from the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee Peripheral Arterial Disease. Journal of Vascular Surgery. Published online November 12, 2024. doi:10.1016/j.jvs.2024.11.003

Primary Safety Endpoint at 30-Days

Results for the primary safety endpoint at 30-days further confirm IVL’s safety and ongoing efficacy in challenging calcium below the knee. 

Two patients required above-ankle amputations of the index limb:  

• One patient had worsening necrotizing fasciitis of the right foot and underwent amputation nine days after index procedure  
• One patient had non healing wounds in multiple areas of the foot and had an amputation nine days after index procedure  

These events were reported as not related to the study device or procedure and the decision to amputate was made on clinical grounds by the treating physician.

Chandra V, Lansky AJ, Sayfo S, et al. Thirty-Day Outcomes from the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee Peripheral Arterial Disease. Journal of Vascular Surgery. Published online November 12, 2024. doi:10.1016/j.jvs.2024.11.003

Freedom from CD-TLR at 24 Months

24-month outcomes confirm the durability of Shockwave IVL’s clinical outcomes in complex calcified BTK disease.

1: Chandra V, Two-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2026.
2: Based on the internal cohort sub analysis.
Clinically driven target revascularization (CD-TLR).
Kaplan Meier (KM) is an analysis that uses probability to capture patients lost to follow-up.
Freedom from CD-TLR analysis excluded patients with above the ankle amputation of target limb.

Freedom from Major Amputation at 24 Months

24-month outcomes establish IVL’s role in limb salvage and enabling functional recovery.

1: Chandra V, Two-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2026.
2: Based on the internal cohort sub analysis.

Rutherford Classification at 24 Months

24-month outcomes show continued durability of Shockwave IVL for calcified BTK treatment, demonstrating sustained clinical benefit in a complex CLTI population.

• RC 3 Cohort: 89% had ≥ 1 RC improvement
• CLTI Cohort: 84% had ≥ 1 RC improvement

Chandra V, Two-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2026.

Quality of Life (QoL) at 24 Months

Shockwave IVL facilitates sustained symptom improvement through 24 months.

• All categories improved. Total VascuQoL-6 Score for both RC 3 and CLTI at 24 months significantly improved from baseline (P-Value: p<0.001).
• RC 3: Total at 24 months was 18.8 ± 4.5 and total at baseline was 12.9 ± 3.8.
• CLTI: Total at 24 months was 18.1 ± 4.6 and total at baseline was 11.9 ± 4.0.

1: Based on the internal cohort sub analysis.
2: Armstrong E, One-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2025.
The Vascular Quality of Life Questionnaire is a survey used to determine health related quality of life (HRQoL) in patients with peripheral arterial disease (PAD). Each attribute is scored 1-4, a higher value indicates better health status. The sum of each individual attribute score is used to generate a total quality of life score.

Chandra V, Lansky AJ, Sayfo S, et al. Thirty-Day Outcomes from the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee Peripheral Arterial Disease. Journal of Vascular Surgery. Published online November 12, 2024. doi:10.1016/j.jvs.2024.11.003.