Business Wire08.13.21
SoundBite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific peripheral and coronary arterial diseases, announced the use of its Active Wire 0.014” platform at a first site in the United States in the successful treatment of patients suffering from critical limb ischemia (CLI) with heavily calcified lower limb chronic total occlusions (CTO).
The Active Wire was used in procedures at the UNC REX Hospital (NC) by George Adams, M.D., MHS, FACC, director, Cardiovascular and Peripheral Vascular Research; associate professor, Cardiology, UNC School of Medicine. “Peripheral Artery Disease (PAD) and CLI in particular are a threat to life and limb. Our early experience with the 0.014” platform of the SoundBite Crossing System in eight (8) patients with severely calcified disease shows impressive CTO crossing efficacy coupled with safety and simplicity. 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 CLI,” commented Adams.
High calcium burden is present in up to 50 percent of PAD patients with severe claudication and in >65 percent of patients with CLI, especially in difficult to treat below-the-knee (BTK) disease. CTOs are encountered in up to 50 percent of PAD and CLI patients.1,2 Within the first year of CLI diagnosis, 25 percent of patients die and 25 percent will have a major limb amputation as primary treatment, at a cost of $22 billion in the US alone.3,4 Successful revascularization significantly reduces the need for amputations.
“We are excited by the strong results we are seeing with our Active Wire in severely calcified peripheral lesions and look forward to the day when our unique technology platform and devices become the standard of care for all difficult-to-treat peripheral vascular lesions worldwide,” commented Lori Chmura, president and CEO of SoundBite.
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, U.S. Food and Drug Administration (510(k)) clearance, and Health Canada approval in both 0.018” and 0.014’’ platforms.
References
1 Murabito JM et al. Am Heart J. 2002;143(6):961–965. [PubMed] [Google Scholar]
2 Fanelli, J Cardiovasc Surg 2014
3 Abu Dabrh AM, et al. J VascSurg. 2015;62(6):1642–1651. [PubMed] [Google Scholar]
4 Norgren L, et al. J Vasc Surg. 2007;45(suppl S):S5–S67. [PubMed] [Google Scholar] The SAGE Group
The Active Wire was used in procedures at the UNC REX Hospital (NC) by George Adams, M.D., MHS, FACC, director, Cardiovascular and Peripheral Vascular Research; associate professor, Cardiology, UNC School of Medicine. “Peripheral Artery Disease (PAD) and CLI in particular are a threat to life and limb. Our early experience with the 0.014” platform of the SoundBite Crossing System in eight (8) patients with severely calcified disease shows impressive CTO crossing efficacy coupled with safety and simplicity. 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 CLI,” commented Adams.
High calcium burden is present in up to 50 percent of PAD patients with severe claudication and in >65 percent of patients with CLI, especially in difficult to treat below-the-knee (BTK) disease. CTOs are encountered in up to 50 percent of PAD and CLI patients.1,2 Within the first year of CLI diagnosis, 25 percent of patients die and 25 percent will have a major limb amputation as primary treatment, at a cost of $22 billion in the US alone.3,4 Successful revascularization significantly reduces the need for amputations.
“We are excited by the strong results we are seeing with our Active Wire in severely calcified peripheral lesions and look forward to the day when our unique technology platform and devices become the standard of care for all difficult-to-treat peripheral vascular lesions worldwide,” commented Lori Chmura, president and CEO of SoundBite.
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, U.S. Food and Drug Administration (510(k)) clearance, and Health Canada approval in both 0.018” and 0.014’’ platforms.
References
1 Murabito JM et al. Am Heart J. 2002;143(6):961–965. [PubMed] [Google Scholar]
2 Fanelli, J Cardiovasc Surg 2014
3 Abu Dabrh AM, et al. J VascSurg. 2015;62(6):1642–1651. [PubMed] [Google Scholar]
4 Norgren L, et al. J Vasc Surg. 2007;45(suppl S):S5–S67. [PubMed] [Google Scholar] The SAGE Group
