DISRUPT PAD II

By The Numbers

60
Patients with HEAVILY CALCIFIED femoral-popliteal lesions
85%
SEVERE calcification by PARC1
98mm
Average calcified length

Compelling Safety & Performance

in Severely Calcified Lesions*
0%
  • Perforations
  • Embolization
  • Thrombus
  • No reflow
  • Abrupt closure
1.7%
  • Dissection (D/E/F)*
  • Provisional stenting

*Guidewire induced through recanalization of a CTO

24%
  • Residual stenosis with average acute gain of 3.0-mm
  • Average balloon inflation pressure of 6 atm after IVL therapy
100%
  • Procedural success
  • Low use of adjunctive tools
79%
  • Freedom from clinically driven revascularization at 1-year
  • With simple revascularization procedures
*Core Lab and CEC Adjudicated

Patients who were treated with optimal technique had less than 9% CD-TLR at 12-months*

15%
improved primary patency and rate of CD-TLR with optimal technique
chart1

Balloon sizing and therapeutic overlap enables optimal energy delivery to calcified lesions.

Optimal

col1

Undersized

col2
Oversize Device 10% vs. RVD to Facilitate Energy Transfer

Full Therapeutic Coverage

col3
Therapeutic Miss col4

Overlap Segments

1cm to Avoid Therapeutic Miss
1. Brodmann M et al, Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II, Catheter Cardiovasc Interv. 2018

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Caution: Investigational device. Limited by Federal (U.S.) law to investigational use.
ISI: https://shockwavemedical.com/important-safety-information-coronary/