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The SoundBite® Crossing System XS Peripheral is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions. The SoundBite® Crossing System XS Peripheral is not intended for use in the carotid arteries.

The SoundBite® Crossing System XS Peripheral, is a recanalization device designed to help physicians place a conventional guidewire or treatment device in the intraluminal space beyond peripheral chronic total occlusions (CTOs). It is intended for use in a professional healthcare facility, such as a catheterization laboratory, also known as a Cath Lab. The system consists of the AC-powered, reusable, mobile SoundBite® Console XS with a Foot Switch, and a single-use, sterile SoundBite® Active Wire XS 14P packaged together with two accessories, the SoundBite® Curving Tool 14 and the SoundBite® Torquer. The AC-powered, reusable, mobile SoundBite® Console XS is an iteration of the predicate device, re-engineered for improved usability but with similar design, functional, safety, and performance specifications. It generates controlled, high-amplitude, short-duration mechanical pulses (i.e., shock waves) that are transmitted to the connected SoundBite® Active Wire XS 14P and cause the distal end of the wire to move back and forth (axially), acting like a micro-jackhammer. The single-use SoundBite® Active Wire XS 14P is a 350 cm long metallic wire with an outer diameter of 0.36 mm (0.014") over its usable length. It is similar in construction to the Active Wire of the predicate and reference devices, but 50 cm longer. The proximal end of the SoundBite® Active Wire XS 14P includes a connector assembly that encapsulates a wire section reducer for easy connection to the SoundBite® Console XS, and a Radio Frequency ldentification (RFID) tag that allows the SoundBite® Console XS to detect and uniquely identify the wire and track its use. A thermoplastic elastomer sleeve was also added to proximal length of the wire during use.

The SoundBite® Crossing System - Peripheral (14P) is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions. The SoundBite® Crossing System - Peripheral (14P) is not intended for use in the carotid arteries.

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 in the peripheral vasculature. The SoundBite® Crossing System - Peripheral (14P) consists of the reusable mobile SoundBite® Console, a single-use sterile SoundBite® Active Wire 14P, and their respective accessories. The SoundBite® Console generates controlled mechanical pulses (i.e., shock waves) which are transmitted to the SoundBite® Active Wire 14P and cause the distal tip of the wire to accelerate axially in a reciprocating motion, acting like a micro-jackhammer. The SoundBite® Active Wire 14P is similar in construction to the 0.018" CTO crossing wire provided with the predicate device, with a friction reducing PTFE coating (except for the distal tip), a radiopaque marker near the tip, and enhanced flexibility at the distal end. It has an outer diameter of 0.36 mm (0.014") and it is 300 cm long, with a working length of 145 cm. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console. The single-use SoundBite® Active Wire 14P is supplied sterile with a shelf life of 24 months.