Safety and Performance of the IVL Technology System
A two-phase, single arm, prospective, multicenter study designed to demonstrate the safety and performance of the Shockwave Medical IVL System in the treatment of calcified femoropopliteal lesions up to 15 cm in length which enrolled 95 patients at eight centers.
The study was managed with 100% source document verification and with independent angiographic and duplex ultrasound core labs as well as an independent clinical events committee.
To learn more about the two phases please visit:
Safety and Performance Study of the Shockwave IVL System (DISRUPT-PAD) and
Shockwave IVL DISRUPT Trial for PAD (DISRUPT PAD 2).
The study demonstrated compelling safety and performance results with the Shockwave Medical IVL System in the treatment of patients with calcified, stenotic peripheral arteries. Treatment with IVL Technology resulted in a low residual stenosis of 24% and with only 1 stent implanted. In patients followed to date six month results showed favorable patency, low target lesion revascularizations and one major adverse event, a single grade D dissection resolved with a stent.
IVL Technology achieved 100% procedural success with an average post-procedure residual stenosis rate of 23.8%, and an acute gain of 3.0 mm following IVL Treatment. Only 1 stent (1.1%) was implanted.
IVL Catheters have shown effective deliverability with 100% successful crossing of moderate and severely calcified lesions with limited need for adjunctive therapy:
Six Month Performance
DISRUPT PAD demonstrated no procedural complications related to perforations, abrupt closure, slow/no reflow, thrombosis or distal embolization.
One subject experienced a Grade D dissection requiring a stent and no additional complications.