SoundBite Medical Solutions has announced it has received CE marking for the SoundBite Crossing System, a novel first-in-class wire-based technology that is intended for the treatment or peripheral chronic total occlusions (CTOs) in a simpler and clinically efficient method.
“We are pleased that our notified body verified that we have objectively demonstrated the safety and efficacy in Europe of our CTO crossing technology throughbench and clinical studies,” said Marc-André Côté, director of Regulatory Affairs at SoundBite Medical, “and that we were able to demonstrate the effective tracking of our activities in an ISO 13485-certified quality management system,” added Abderrahim Benrabah, vice president of the company’s Quality Engineering department.
CE Marking indicates that the product complies with the Essential Requirements of the 93/42/EEC Directive and is authorised to be distributed and commercialised in the European market.
“The CE marking is the culmination of our efforts to engineer and manufacture a product that satisfies all the European requirements for a medical device,” said Domenic Santoianni, director of Product Development.
“The award of our first CE Mark is a significant milestone for the Company,” said co-founder and CEO of the company, Martin Brouillette, “and is the direct result of the tenacious efforts and exemplary dedication of our excellent team of employees.”
SoundBite Medical Solutions is a Canada-based company developing its shock wave technology in an effort to address significant unmet clinical needs within interventional vascular treatment. Through a combination of hardware and software, the technology delivers high amplitude shock wave pulses in a controllable manner through guidewires and other interventional tools, to specifically attack highly calcified and fibrotic tissue in the vascular system, while leaving healthy, elastic arterial walls unharmed.