Michael Barbella, Managing Editor03.02.21
Soundbite Medical Solutions has added another regulatory approval to its peripheral artery disease (PAD) treatment arsenal.
The privately-held firm recently received Health Canada's blessing for the SoundBite Crossing System - Peripheral (SCS-P) with the 0.014-inch Active Wire (14P).
“Expanding our technology and product portfolio in Canada is an important milestone for our company in the journey to commercialize the SoundBite system. This is welcome news on the back of our recent positive experience with the system in the EU. We are looking forward to making a positive impact on patients by providing a novel and safe solution around the world,” said Lori Chmura, president and CEO of SoundBite Medical.
The SCS-P (14P) is intended to treat patients suffering from PAD with heavily calcified above-the-knee (ATK) and below-the-knee (BTK) chronic total occlusions (CTO).
Calcium remains the “Achilles heel” in the endovascular treatment of PAD, including critical limb ischemia (CLI). CLI 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 to 40 percent of patients at six months, especially in non-treatable patients.4,5
The SCS-P 14P system comprises the SoundBite Console and the 0.014-inch SoundBite Active Wire. SCS-P leverages Soundbite’s proprietary method to produce and safely deliver shock waves via guidewire platforms to selectively ‘micro- jackhammer” through calcified lesions. SBCS-P has CE marked and Health Canada approval in both 0.018-inch and 0.014-inch platforms; the 0.018-inch platform has also U.S. Food and Drug Administration (510k) approval.
Soundbite is a 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 guidewire-based devices to improve and transform the standard of care for treatment of patients suffering from calcified and occlusive cardiovascular disease.
References
1 Murabito JM et al. Am Heart J. 2002;143(6):961–965. [PubMed] [Google Scholar]
2 Adam DJ, et al. Lancet. 2005;366(9501):1925–1934. [PubMed] [Google Scholar]
3 Stoyioglou A, Jaff MR. J Vasc Interv Radiol. 2004;15(11):1197–1207. [PubMed] [Google Scholar]
4 Abu Dabrh AM, et al. J Vasc Surg. 2015;62(6):1642–1651. [PubMed] [Google Scholar]
5 Norgren L, et al. J Vasc Surg. 2007;45(suppl S):S5–S67. [PubMed] [Google Scholar]
The privately-held firm recently received Health Canada's blessing for the SoundBite Crossing System - Peripheral (SCS-P) with the 0.014-inch Active Wire (14P).
“Expanding our technology and product portfolio in Canada is an important milestone for our company in the journey to commercialize the SoundBite system. This is welcome news on the back of our recent positive experience with the system in the EU. We are looking forward to making a positive impact on patients by providing a novel and safe solution around the world,” said Lori Chmura, president and CEO of SoundBite Medical.
The SCS-P (14P) is intended to treat patients suffering from PAD with heavily calcified above-the-knee (ATK) and below-the-knee (BTK) chronic total occlusions (CTO).
Calcium remains the “Achilles heel” in the endovascular treatment of PAD, including critical limb ischemia (CLI). CLI 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 to 40 percent of patients at six months, especially in non-treatable patients.4,5
The SCS-P 14P system comprises the SoundBite Console and the 0.014-inch SoundBite Active Wire. SCS-P leverages Soundbite’s proprietary method to produce and safely deliver shock waves via guidewire platforms to selectively ‘micro- jackhammer” through calcified lesions. SBCS-P has CE marked and Health Canada approval in both 0.018-inch and 0.014-inch platforms; the 0.018-inch platform has also U.S. Food and Drug Administration (510k) approval.
Soundbite is a 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 guidewire-based devices to improve and transform the standard of care for treatment of patients suffering from calcified and occlusive cardiovascular disease.
References
1 Murabito JM et al. Am Heart J. 2002;143(6):961–965. [PubMed] [Google Scholar]
2 Adam DJ, et al. Lancet. 2005;366(9501):1925–1934. [PubMed] [Google Scholar]
3 Stoyioglou A, Jaff MR. J Vasc Interv Radiol. 2004;15(11):1197–1207. [PubMed] [Google Scholar]
4 Abu Dabrh AM, et al. J Vasc Surg. 2015;62(6):1642–1651. [PubMed] [Google Scholar]
5 Norgren L, et al. J Vasc Surg. 2007;45(suppl S):S5–S67. [PubMed] [Google Scholar]
