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pad ii 1

First and only core lab adjudicated, long term study exclusively enrolling heavily calcified lesions1

Multi-center study prospectively enrolling heavily calcified, stenotic, femoropopliteal arteries. Initial experience using novel Intravascular Lithotripsy (IVL) to treat problematic calcified lesions. Designed to assess the safety and performance of IVL as stand-alone treatment among 8 centers in Europe and New Zealand in 2015.

DISRUPT PAD II

By The Numbers

60
Patients with HEAVILY CALCIFIED femoral-popliteal lesions
85%
SEVERE calcification by PARC1
98mm
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
*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
Wall apposition facilitates efficient energy transfer. Optimized balloon sizing leads to improved patency

Full Therapeutic Coverage

 col3
Therapeutic Miss col4

Overlap Segments

 1cm to Avoid Therapeutic Miss
The sonic pressure waves create a spherical field effect that drops as the longitudinal distance from the emitters increases
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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