FDA Clears Soundbite Medical’s Recanalization Tool

Soundbite Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SoundBite Crossing System – Peripheral (SCS-P) with the 0.014-inch 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 relevant as it represents the latest testament to our comprehensive and long-term 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 percent within six months after diagnosis and 50 percent at five 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 percent–40 percent of patients at six 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 510(k), and Health Canada approvals in both 0.018-inch and 0.014-inch platforms.
 
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. 
 
References
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