SoundBite Commences ACTIVE Coronary CTO Pivotal Clinical Study
September 21, 2018—SoundBite Medical Solutions Inc. announced commencement of the ACTIVE trial, which was recently approved by Health Canada to evaluate the safety and efficacy of the SoundBite Active Wire to cross coronary chronic total occlusions (CTOs).
The North American, multicenter, 154-patient, phased clinical trial has started in Canada and is expected to gain an investigational device exemption from the FDA within the next few months, advised the company.
The first two patients enrolled in the ACTIVE trial were treated by Principal Investigator Stephane Rinfret, MD, Chief of Interventional Cardiology at the McGill University Health Center (MUHC) in Montreal, Quebec. In the company's announcement, Dr. Rinfret commented, “Our team, at the MUHC is proud to be involved in the first coronary CTO crossing application of the revolutionary new SoundBite shock wave system. The positive results obtained with the first two patients launch this determinant clinical trial in the evaluation of this new technology for the treatment of complex calcified coronary occlusions.”