SoundBite Medical Solutions recently announced the use of its novel Active Wire 0.014” platform at a first site in the USA in the successful treatment of patients suffering from chronic limb-threatening ischaemia (CLTI) with heavily calcified lower limb chronic total occlusions (CTO).
The Active Wire was used in procedures at the UNC REX Hospital (Raleigh, USA) by George Adams, who commented: “Peripheral arterial disease (PAD) and CLTI in particular are a threat to life and limb. Our early experience with the 0.014” platform of the SoundBite crossing system in eight patients with severely calcified disease shows impressive CTO crossing efficacy coupled with safety and simplicity”.
He continued: “In several cases, crossing and treatment would not have been possible with standard techniques. With an increased demand for devices to aid in treatment algorithms for calcific plaque morphologies, we look forward to building on our experience with the system. The broader introduction of the SoundBite system holds promise to be game-changing in treating calcified CTOs and enabling better treatment outcomes in a difficult-to-treat patient population suffering from PAD and CLTI,” commented Adams.
The SoundBite crossing System—Peripheral (SCS-P) consists of the reusable SoundBite console, a single-use sterile SoundBite Active Wire, 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, US Food and Drug Administration (FDA) 510(k) clearance, and Health Canada approval in both 0.018” and 0.014’’ platforms.