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

Publications

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Brodmann M, et al, Safety and Performance of Lithoplasty for Treatment of Calcified Peripheral Artery Lesions, J Am Coll Cardiol 2017
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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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MINIMIZE TRAUMA

Minimize trauma to soft tissue by safely selecting and fracturing intimal and medial calcium

 

OPTIMIZE OUTCOMES

Optimize outcomes while reducing complications and cost escalation

 

SIMPLIFY PROCEDURES

Simple and intuitive system that makes complex calcified procedures more predictable

 

 

SHOCKWAVE M5 IN-DEPTH

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