Soundbite Medical Solutions Receives FDA 510(k) Clearance for the SoundBite® Crossing System – Peripheral (14P)
MONTREAL – April 22nd, 2021 – Soundbite announces the company has received Food and Drug Administration (FDA) 510(k) clearance for the 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 clearance 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 clearance is very relevant as it represents the latest testament to our comprehensive and longterm commitment to revolutionizing the treatment of CTOs and PAD with our family of safe and effective Active solutions” said Lori Chmura, President and CEO of SoundBite Medical.
The presence of CTOs and calcified lesions pose significant challenges in the endovascular treatment of PAD, including CLI. Critical limb ischemia is the most severe form of PAD and is associated with a high risk of major amputation, cardiovascular events and death.1 A mortality rate of 20% within 6 months after diagnosis and 50% at 5 years has been reported in patients diagnosed with CLI.2,3 Furthermore, CLI is associated with peripheral complications such as ulceration, gangrene, infection and a high risk of lower limb amputation estimated in 10%–40% of patients at 6 months, especially in non-treatable patients.4,5
The SoundBite® Crossing System – Peripheral (14P) consists of the reusable SoundBite® Console, a single-use sterile SoundBite® Active Wire 14P, and their respective accessories. SCS-P leverages Soundbite’s proprietary method to produce and safely deliver shock waves via guidewire platforms to selectively “micro- jackhammer” through calcified lesions. SCS-P is now approved in major markets with CE mark, FDA (510k) clearance, and Health Canada approval in both 0.018” and 0.014’’ platforms.
About Soundbite Medical Solutions
Soundbite is a privately held medical device company uniquely dedicated to developing meaningful solutions for the interventional treatment of calcific peripheral and coronary arterial diseases. Soundbite has developed and deployed a proprietary method to produce and safely deliver shock waves to calcified lesions using an array of devices to improve and transform the standard of care for treatment of patients suffering from calcified and occlusive cardiovascular disease. www.soundbitemedical.com
For information on Soundbite Medical Solutions, please contact Ashkan Haghighat (firstname.lastname@example.org), SoundBite Medical Solutions, 2300 Alfred Nobel, Montreal Québec H4S 2A4
Forward-Looking Statements This press release contains forward-looking statements and forward- looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate” or the negatives of these terms, or variations of them. Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond SoundBite Medical Solutions Inc.’s control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward looking statements. Forward- looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances.
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