FIH Study Evaluates SoundBite's Shock Wave Energy System for Peripheral CTO Crossing Procedures
December 20, 2017—SoundBite Medical Solutions Inc. announced the completion of its first-in-human prospective, single-arm, multicenter clinical trial of the SoundBite shock wave energy system, which is being developed to treat both peripheral and coronary artery disease.
According to the company, the SoundBite shock wave energy system is composed of a combination of hardware and software to deliver high-amplitude shock wave pulses in a controllable manner through guidewires and other interventional tools. The shock wave pulses specifically attack highly calcified and fibrotic tissue in the vascular system, while leaving healthy, elastic arterial walls unharmed.
The trial enrolled 37 patients with chronic total occlusions (CTOs) who were treated at three sites (Université Montréal in Montréal, Quebec; Sherbrooke University Hospital in Sherbrooke, Quebec; and Medical University Graz in Graz, Austria). In total, 41 lesions (average CTO length, 9.8 cm) were treated with an average activation time per lesion of 3 minutes 37 seconds. The clinical success rate was 92%, and there were no serious adverse events.
The trial's Principal Investigator Andrew Benko, MD, is Chief of Angiography and Endovascular Therapy at the Sherbrooke University Hospital. Investigator Éric Thérasse, MD, is from the Department of Radiology, Radio-Oncology and Nuclear Medicine, Université de Montréal. Marianne Brodmann, the European Principal Investigator, is from the Department of Internal Medicine of the Medical University Graz.
In the company's announcement, Dr. Benko commented, “This technology fulfills an important need in the field of CTO intervention, as it can convert failed procedures into successes, giving the patient relief from ischemic pain and even saving their limb.”
Dr. Thérasse stated, “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 patients’ blocked arteries.”
With more than one-third of treated lesions being severely calcified, Prof. Brodmann observed, “With SoundBite guidewire technology we could achieve more CTO crossings, which might make it easier to treat this complex patient cohort through endovascular procedures instead of surgery.”
The company's clinical trial program will support its initiatives for commercialization of the technology in the United States, Canada, and Europe.