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Put the Pop in FemPop

Improve outcomes and contain costs in complex, calcified fempop
  • Calcium can result in unpredictable and costly acute failures or complications
  • Calcium also acts as a barrier to drug uptake
  • IVL safely fractures calcium, reducing common failure modes of conventional treatments
Featured Case
Heavily Calcified Popliteal; Courtesy of Marianne Brodmann, MD, University of Graz, Graz, Austria

PREDICTABLY SAFE

Safely modify calcium while significantly reducing the risk of complications to make procedures more predictable and efficient

 

DISTINCTLY INTUITIVE

Simplify the treatment of calcium from the very first case via a unique MOA on an intuitive platform

 

CONSISTENTLY EFFECTIVE

Proven to achieve low residual stenosis across multiple vessel beds by disrupting superficial and deep calcium

 

 

SHOCKWAVE M5 IN-DEPTH

DISRUPT PAD II

By The Numbers

60
Patients with HEAVILY CALCIFIED femoral-popliteal lesions
85%
Severe calcification by PARC
98m
Average calcified length
Followed out to 12-months

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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