SoundBite’s Shockwire Guidewire First-in-Human Procedure Successful
December 27, 2016—SoundBite Medical Solutions Inc. announced it has completed its first-in-human procedure using shockwave energy to successfully and safely cross a chronic total occlusion.
The procedure was performed at Sherbrooke University Hospital, in Sherbrooke, Quebec, Canada, by Andrew Benko, MD, Head of Interventional Radiology. The patient, a 72-year-old man, had bilateral superficial femoral artery occlusions in his legs (both > 20 cm long). Dr. Benko performed the minimally invasive procedure using SoundBite's Shockwire 0.018-inch guidewire to deliver high-energy shockwaves into the patient’s arteries to completely cross both occlusions, including several calcified nodules, and reestablish blood flow.
“I was very pleased with the clinical performance of the SoundBite Crossing System and the clinical outcome that resulted in the safe and effective reestablishment of blood flow in both arteries treated,” commented Dr. Benko in the company’s press release. “Versus other nonactive guidewires, I found that the Shockwire provided a higher degree of control and versatile crossing capability.”
According to the company, the procedure was well tolerated and the patient was discharged the same day without complications.
SoundBite’s Shockwire guidewire is not currently available for use in the United States or the European Union.