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February 9, 2021
SoundBite Crossing System—Peripheral 14P Receives Health Canada Approval
February 9, 2021—Soundbite Medical Solutions Inc. (SBMS) announced Health Canada approval for the SoundBite crossing system–peripheral (SCS-P) with the 0.014-inch active wire (14P).
The SCS-P 14P device is intended for the treatment of patients who have peripheral artery disease with heavily calcified above-the-knee and below-the-knee chronic total occlusions (CTOs). The privately held company is headquartered in Montreal, Quebec.
According to SBMS, the SCS-P 14P system is composed of the SoundBite console and the 0.014-inch SoundBite active wire technology. SCS-P leverages the company’s method to produce and safely deliver shockwaves via guidewire platforms to selectively “microjackhammer” through calcified lesions.
SBCS-P has received European CE Mark approval and Health Canada approval in both 0.018- and 0.014-inch platforms. Also, the 0.018-inch platform has FDA 510(k) clearance.
On January 26, SBMS announced the first use of its 0.014-inch active wire platform in the successful treatment of patients who have critical limb ischemia with heavily calcified below-the-knee CTOs. The procedures were performed by Professor Marianne Brodmann, MD, and Peter Rief, MD, at the Medical University of Graz in Graz, Austria.
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