DISRUPT BTK II

*Frontline Strategy: The approach of utilizing IVL as the primary treatment method, implemented without the use of atherectomy. This strategy is backed by the BTK II data based on the percentage of procedures involving pre-dilatation and post-dilatation, as well as the proportion of stenting performed. Our BTK II data indicates a notably low usage of both pre-dilatation and post-stenting in these cases.
Armstrong E, VIVA 2025

* 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.

*The majority of patients enrolled had CLTI, thus a majority of the comorbidities are attributed to this population.

Medical History 

Rutherford Category 

Lesions 

*Enrollment of RC3 was capped at 20% | †PARC Definition
Armstrong E, VIVA 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 and Patency at 12 Months

12-month outcomes confirm the durability of IVL through sustained vessel patency and low reintervention rates which lead to limb preservation and ongoing symptom relief.

Armstrong E, VIVA 2025 | 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 12 Months

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

Armstrong E, VIVA 2025 | Kaplan Meier (KM) is an analysis that uses probability to capture patients lost to follow-up.

Rutherford Classification at 12 Months

In a majority of patients with CLTI, IVL plays a critical role in laying the foundation for successful wound healing through safe and effective revascularization

• At baseline, 80% of patients experienced CLTI which improved to just 25.1% in patients with available 12-months follow-up
• 61% of wounds were healed or improving*

Armstrong E, VIVA 2025
*Mean Wound Follow Up Time: 157 days
Available data at 12 months is 159 limbs out of 251 limbs.

Quality of Life (QoL) at 12 Months

As part of revascularization, IVL facilitates sustained symptom improvement through 12 months.

• All categories improved. Total VascuQoL-6 Score for both RC 3 and CLTI at 12 months significantly improved from baseline (P-Value: p<0.001).
• RC 3: Total at 12 months was 18.5 ± 4.7 and total at baseline was 12.9 ± 3.8.
• CLTI: Total at 12 months was 17.2 ± 5.0 and total at baseline was 11.9 ± 4.0.

Armstrong E, VIVA 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