Overview of Upcoming New IVL System Launches

Research evidence excerpt

Overview of Upcoming New IVL System Launches

sing. Shockwave

is currently developing its SkyRunner Carotid IVL for calcium modification before carotid stenting. JNJ

is currently conducting the SKYWARD TF pivotal trial which is expected to be completed in late 2027

(https://clinicaltrials.gov/study/NCT07512128). It is important to note that Shockwave is on its 5th-

gen coronary catheter with the C2 Aero.

A few areas that competitors are seeking to address:

1) Long or multiple lesions with Shockwave can exhaust a catheter and require a second device, which

drives up procedure cost. Shockwave’s spark-emitter design limits each catheter to a fixed pulse count

(~120 coronary / ~300–400 peripheral).

2) Some experts believe that the two emitters on Shockwave’s coronary catheters deliver less uniform

energy along the balloon.

3) Earlier Shockwave coronary catheters often required ancillary devices for positioning and were

limited to a distal-to-proximal approach. We note that this limitation is now addressed by Shockwave’s

C2 Aero catheter.

4) Shockwave delivered roughly 1 pulse/sec historically for coronary while other IVL systems may be

looking to improve the pulse cadence to drive a faster and more efficient treatment.

BSX’s Seismiq. Seismiq’s laser/optics-based energy is designed to deliver consistent acoustic pressure

and designed for high pulse capacity to treat longer, more heavily calcified lesions, and to fracture

both concentric and eccentric calcium. The peripheral catheter provides 120 pulses across 5 emitter

stations with real-time feedback, while the coronary Seismiq 4CE has four coronary emitters. The

Seismiq handle does not require sterile bagging. Importantly, Seismiq requires a laser generator, which