SoundBite Initiates Human Clinical Studies for Peripheral CTO Crossing Procedures
MONTREAL., SoundBite Medical Solutions Inc. (SBMS) announced today that it has performed its First-In-Human (FIH) procedure using shockwave energy to successfully and safely cross a chronic total occlusion (CTO). The 72-year-old male patient had bilateral superficial femoral artery occlusions (both over 20 cm in length) in the legs, leading to incapacitating claudication and unfavorable quality of life. Dr. Andrew Benko, performed the minimally invasive procedure using a .018” guidewire (ShockWire™) that delivered high energy shockwaves into the patient’s arteries to completely cross both occlusions including several calcified nodules and re-establish blood flow. In up to 30% of cases, these type of occlusions could be difficult and sometimes impossible to cross, resulting in a need for surgical intervention and potentially amputation.
Dr. Benko, Head of Interventional Radiology, successfully performed the procedure at the Sherbrooke University Hospital (CHUS) in Sherbrooke, Quebec (Canada). The patient tolerated the procedure very well, had blood flow re-established in both affected arteries and was discharged later the same day without complications.
“I was very pleased with the clinical performance of the SoundBite Crossing System and the clinical outcome that resulted in the safe and effective re-establishment of blood flow in both arteries treated” said Dr. Benko. Versus other non-active guidewires, I found that the Shockwire provided a higher degree of control and versatile crossing capability. Furthermore, the fact that I was able to cross the first 20 cm lesion with a single Shockwire, and with less than 3 minutes of power activation, was very encouraging”.
“The outcome of this vascular procedure shows our commitment to targeting difficult-to-cross CTO’s. This is a significant milestone, not only for the Company but also for all patients who suffer from severe progression of PAD or CAD,” said Co-Founder and CEO, Steve Arless. “Our clinical journey has now begun, and we are steadily moving towards an international pivotal study in 2017, ultimately paving the way towards commercialization in the US, Europe and Canada thereafter”.
CTO’s are complete blockages of arteries, which are the result of severe progression of peripheral artery disease (PAD) and coronary artery disease (CAD), two prevalent and growing cardiovascular conditions affecting over 14 million and 10 million of North Americans, respectively. Risk factors for PAD and CAD include: Diabetes, Smoking, Obesity, High Blood Pressure and Cholesterol. It is estimated that 40% of the PAD population and 30% of the CAD population possess CTO’s.
SoundBite Medical Solutions Inc.