SoundBite Marks First Use of Active Wire 0.014-Inch Platform to Treat CTOs in CLI

June 2, 2021—SoundBite Medical Solutions Inc. (SBMS) announced the first use of its active wire 0.014-inch platform in the United States for the treatment of critical limb ischemia (CLI) in patients with heavily calcified lower limb chronic total occlusions (CTO). George Adams, MD, performed the procedures at UNC Rex Hospital in Raleigh, North Carolina.

“Peripheral artery disease (PAD) and CLI in particular are a threat to life and limb. Our early experience with the 0.014-inch platform of the SoundBite crossing system in eight patients with severely calcified disease shows impressive CTO crossing efficacy coupled with safety and simplicity,” commented Dr. Adams in the SBMS press release. “In several cases, crossing and treatment would not have been possible with standard techniques.”

Dr. Adams continued, “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 CLI.”

Dr. Adams is Director, Cardiovascular and Peripheral Vascular Research, and Associate Professor, Cardiology, UNC School of Medicine at the University of North Carolina at Chapel Hill, North Carolina.

SBMS advised that high calcium burden is present in up to 50% of PAD patients with severe claudication and in > 65% of patients with CLI, especially in difficult to treat below-the-knee disease. Additionally, CTOs are encountered in up to 50% of PAD and CLI patients. Within the first year of CLI diagnosis, 25% of patients die and 25% will have a major limb amputation as primary treatment, at a cost of $22 billion in the United States alone. Successful revascularization significantly reduces the need for amputations, noted the company.

The company noted that 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 SBMS’s method to produce and safely deliver shock waves via guidewire platforms to selectively “micro-jackhammer” through calcified lesions.

SCS-P has CE Mark approval, FDA 510(k) clearance, and Health Canada approval in both 0.018- and 0.014-inch platforms, stated SBMS.