Recanalization of CTOs with SoundBite™ Active Wire.

BACKGROUND: The aim of this study was to examine the safety and efficacy of the SoundBite™ Crossing System for the recanalization of infrainguinal chronic total occlusion (CTO) lesions. CTOs are frequent among patients with severe claudication or critical limb ischemia. Failure to recanalize CTOs remains common and is associated with poor prognosis. The SoundBite™ Crossing System (SoundBite Medical Solutions Inc., Montreal, QC, Canada) is a newly developed device that uses a 0.018-inch wire (SoundBite™ Active Wire) to deliver acoustic shock waves to the distal tip of a steerable guidewire to facilitate directed penetration of the proximal cap and crossing of the occlusion. METHODS: Symptomatic patients with de novo infrainguinal CTOs from 3 centers were enrolled in a prospective, single-arm feasibility study. The primary endpoint was 30-day device success defined as composite of technical success, defined as penetration and progression within the CTO with the SoundBite™ Active Wire followed by complete recanalization, and freedom from device-related major adverse events including death, urgent amputation, clinically-driven target vessel revascularization, perforation, type ≥C dissection, or distal embolization requiring intervention. RESULTS: Thirty-seven patients including 41 CTO lesions were enrolled in this study. CTO length ranged from 10 mm to 270 mm (mean 97.9±77.4 mm), and moderate-to-severe calcification was present in 24 (58.5%) of the treated lesions. CTOs were successfully crossed in 34 (91.9%) patients. No device-related adverse events occurred, resulting in a 30-day device success rate of 91.9%. Compared with baseline, 30-day ankle brachial index (0.66±0.24 versus 0.89±0.20; P<0.001) and Rutherford class (3 [2, 4] versus 0 [0, 1], P<0.001) significantly improved. CONCLUSIONS: The SoundBite™ Active Wire Crossing System feasibility study demonstrates a favorable safety and efficacy profile for the SoundBite™ Active Wire in infrainguinal CTOs.

Novel Crossing System for the Recanalization of Complex Chronic Total Occlusions: Ex vivo Proof of Concept of the SoundBite Crossing System.

Chronic total occlusion (CTO) lesions are frequent in patients with peripheral and coronary artery disease, and associated with a higher risk of adverse events, including mortality, decreased quality of life, and increased health-care costs. Percutaneous intervention of CTO lesions has been associated with a lower procedural success rate, and current dedicated CTO devices may be of limited use for the non-CTO expert, and associated with increased intraprocedural complication rates. The SoundBite Crossing System (SoundBite Medical Solutions, Inc) is a newly developed device using shockwaves (short-duration, high-amplitude pressure pulses) to facilitate penetration of the proximal cap and crossing of the occlusion. The current report describes the first use of the SoundBite Crossing System in the recanalization of human ex vivo occluded arteries below the knee during a simulated procedure performed under fluoroscopy. Microcomputed tomography and histologic evaluation of the occluded and recanalized segment are provided to support therapeutic mechanism.

Novel Crossing System for Chronic Total Occlusion Recanalization: First-in-Man Experience With the SoundBite Crossing System.

Chronic total occlusion (CTO) lesions are frequent in patients with peripheral and coronary artery disease, and are associated with a higher risk of adverse events, including mortality, decreased quality of life, and increased health-care costs. Percutaneous intervention of CTO lesions has been associated with a lower procedural success rate, and current dedicated CTO devices may be of limited use for non-CTO experts, and associated with increased intraprocedural complication rates. The SoundBite Crossing System (SoundBite Medical Solutions, Inc) is a newly-developed device using shockwaves (short-duration, high-amplitude pressure pulses) delivered to the tip of guidewire to facilitate penetration of the proximal cap and crossing of the occlusion. The current report describes the first-in-man use of the SoundBite Crossing System in the recanalization of two occluded lower-limb arteries.

Design and development of a new right arm prosthetic kit for a racing cyclist.

This case report describes a newly developed prosthetic arm for a world class trans-humeral amputee cyclist. The proposed solution consists of a new prosthetic kit that was designed to meet requirements of weight, freedom of movement and precise positioning for the disciplines of time-trial, pursuit, road and team sprint. The kit is made of different attachments that can be changed depending on the event the athlete is competing in. The prosthesis is composed of an extended socket made of composite materials, an arm made of aluminum tubes, a universal joint for the junction with the handlebars and different attachments for each bicycle. The system's weight is kept to a minimum using finite element analysis and careful material selection. The universal joint provides the angular degrees of freedom required to allow the athlete to stand up while pedaling, a freedom of movement lost since amputation. In this case report, the athlete's needs are presented and followed by the design of the product using Finite Element modeling. Results are then presented and discussed. This prosthetic kit was used by the athlete for the 2008 Paralympics games in Beijing.