SoundBite initiates human clinical studies for ShockWire peripheral CTO crossing procedures


SoundBite Medical Solutions has performed its first-in-human procedure using shockwave energy to successfully and safely cross a chronic total occlusion (CTO). The 72-year-old male patient had bilateral superficial femoral artery occlusions (both over 20cm in length) in the legs, leading to incapacitating claudication and unfavourable quality of life. Andrew Benko, performed the minimally invasive procedure using a .018” guidewire (ShockWire) that delivered high energy shockwaves into the patient’s arteries to completely cross both occlusions including several calcified nodules and re-establish blood flow.

Benko, head of Interventional Radiology, successfully performed the procedure at the Sherbrooke University Hospital (CHUS) in Sherbrooke, Canada. The patient tolerated the procedure very well, according to a company release, had blood flow re-established in both affected arteries and was discharged later the same day without complications.

“I was very pleased with the clinical performance of the SoundBite crossing system and the clinical outcome that resulted in the safe and effective re-establishment of blood flow in both arteries treated” says Benko. “Versus other non-active guidewires, I found that the Shockwire provided a higher degree of control and versatile crossing capability. Furthermore, the fact that I was able to cross the first 20cm lesion with a single Shockwire, and with less than three minutes of power activation, was very encouraging”.