SoundBite Medical Solutions Inc. recently completed its first in-human successful treatment with its Active Wire 0.014-inch platform.
“There is significant unmet need for devices to safely and easily prepare calcified vessels in patients with occlusive peripheral vascular disease in general, and in patients with BTK disease in particular. We are encouraged by this early experience and are committed to bringing our technology to clinically enhance the way we tackle CTOs and complex calcified cases in this undertreated and challenging patient population,” commented Lori Chmura, president and CEO of SoundBite.
Calcification and CTO encounter is increasingly common in patients with peripheral artery disease (PAD) and CLI and represent important independent predictors of failure for current endovascular device strategies. The leading failure modality in PAD and CLI (especially BTK) interventions remains the inability to cross calcific CTOs and to enter into the true Lumen. CLI, a severe form of PAD, is a life-threatening condition associated with significant morbidity and mortality. Within the first year of CLI diagnosis, 25 percent of patients die and 30 percent will have a major limb amputation. Successful revascularization significantly reduces the need for amputations.
The procedures were performed by Professor Marianne Brodmann, head of the Clinical Division of Angiology, Department of Internal Medicine, and PD Dr. Rief at the Medical University of Graz, Austria. “Vascular calcium poses a major challenge for the endovascular treatment of lesions. Our early experience with the 0.014” platform of the SoundBite® Crossing System in 5 patients with calcific BTK CTOs shows impressive crossing efficacy and handling with no procedural complications, including perforations, early recoil, or distal embolization in this difficult-to-treat patient population. The SoundBite technology holds promise to significantly transform the treatment of calcified vascular occlusions in patients with peripheral artery disease,” said Brodmann, M.D.
The SoundBite Crossing System – Peripheral (SBCS-P) is a first-in-class wire-based active device (Active Wires) for crossing CTOs. SBCS-P leverages SoundBite’s proprietary method to produce and safely deliver shock waves via guidewire platforms to selectively ‘micro-jackhammer” through calcified lesions. SMPS-P is CE marked and available in both 0.018-inch and 0.014-inch platforms; the 0.018-inch platform has also U.S. Food and Drug Administration (510k) and Health Canada approvals.