The catheter is attached to the transducer hand-piece. “When activated, vibrational energy is transmitted to the tip of the catheter creating a mechanical impact and cavitation that aids in breaking down occlusive material in the artery and in tunneling through the CTO”. “Following access the recanalization catheter is delivered through a standard guide catheter over a guidewire to the occlusion site”. Once its positioned, the operator retracts the guidewire into the catheter lumen at least 1mm from the catheter tip and activate the system by stepping on the foot switch. “Each recanalization catheter can be activated for a total of five minutes, at which point it could be replaced with another catheter if progress is being made”. The recommended number of catheters is no more than three, equivalent to fifteen minutes of generator activation time which is measured by a counter on the control panel. “As the recanalization catheter progresses through the lesion, the operator can stop the generator at any time and advance the guidewire distally to the occlusion”. Once a wire reaches the central lumen distal to the lesion, the catheter is removed. The physician than proceeds with stenting or DCB treatments to end the case. The studies conducted demonstrate that the device achieved IVUS confirmed intraluminal crossings and
The catheter is attached to the transducer hand-piece. “When activated, vibrational energy is transmitted to the tip of the catheter creating a mechanical impact and cavitation that aids in breaking down occlusive material in the artery and in tunneling through the CTO”. “Following access the recanalization catheter is delivered through a standard guide catheter over a guidewire to the occlusion site”. Once its positioned, the operator retracts the guidewire into the catheter lumen at least 1mm from the catheter tip and activate the system by stepping on the foot switch. “Each recanalization catheter can be activated for a total of five minutes, at which point it could be replaced with another catheter if progress is being made”. The recommended number of catheters is no more than three, equivalent to fifteen minutes of generator activation time which is measured by a counter on the control panel. “As the recanalization catheter progresses through the lesion, the operator can stop the generator at any time and advance the guidewire distally to the occlusion”. Once a wire reaches the central lumen distal to the lesion, the catheter is removed. The physician than proceeds with stenting or DCB treatments to end the case. The studies conducted demonstrate that the device achieved IVUS confirmed intraluminal crossings and