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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


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

Lori Chmura , Alfred Nobel , Ashkan Haghighat , Marianne Brodmann , Department Of Internal Medicine , University Of Graz , Head Of The Clinical Division Angiology , Soundbite Medical Solutions , Health Canada , Soundbite Medical Solutions Inc , Active Wire , Professor Marianne Brodmann , Clinical Division , Internal Medicine , Medical University , Technoparc St Laurent , லோரி கிமுறை , ஆல்ஃபிரட் நோபல் , அஷ்கன் ஹாகிகாட் , துறை ஆஃப் உள் மருந்து , பல்கலைக்கழகம் ஆஃப் க்ர்யாஸ் , ஆரோக்கியம் கனடா , செயலில் கம்பி , மருத்துவ பிரிவு , உள் மருந்து , மருத்துவ பல்கலைக்கழகம் ,