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Soundbite Medical Solutions Announces FDA Approval for SoundBite® Crossing System

Press release content from Business Wire. The AP news staff was not involved in its creation.
Soundbite Medical Solutions Announces FDA Approval for SoundBite® Crossing System - Peripheral (14P)
April 22, 2021 GMT
MONTREAL (BUSINESS WIRE) Apr 22, 2021
Soundbite announces FDA 510(k) Approval for SoundBite ® Crossing System - Peripheral (SCS-P) with the 0.014” Active Wire (14P).
The SoundBite® Crossing System – Peripheral (14P) is a recanalization tool, designed to help physician’s placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions (CTOs) in patients suffering from heavily calcified above-the-knee (ATK) and below-the-knee (BTK) peripheral artery disease (PAD).
“This approval is an important step in furthering our mission of making a positive impact on the lives of patients with critical limb ischemia (CLI) and challenging calcified BTK disease. We believe that this approval is very r ....

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SoundBite Medical Solutions Announces First Use of its Novel 0.014" Active Wire to Successfully Treat Calcified Below-The-Knee CTOs

Press release content from Business Wire. The AP news staff was not involved in its creation.
SoundBite Medical Solutions Announces First Use of its Novel 0.014” Active Wire to Successfully Treat Calcified Below-The-Knee CTOs
January 26, 2021 GMT
MONTREAL (BUSINESS WIRE) Jan 26, 2021
SoundBite Medical Solutions Inc. (SBMS) announced today the first use of its novel Active Wire 0.014” platform in the successful treatment of patients suffering from critical limb ischemia (CLI) with heavily calcified below-the-knee (BTK) chronic total occlusions (CTO).
The procedures were performed by Professor Marianne Brodmann, Head of the Clinical Division of Angiology, Department of Internal Medicine, and PD Dr Rief at the Medical University of Graz, Austria. “Vascular calcium poses a major challenge for the endovascular treatment of lesions. Our early experience with the 0.014” platform of the SoundBite ® Crossing System in 5 patients with calcific BTK CTOs shows im ....

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