Stealth 360 is designed to enable simultaneous modification of both intimal and medial calcium. Its diamond-coated crown rotates 360 degrees has a dual-action technology that allows superficial sanding to modify intimal calcium and produces pulsatile force to remove medial calcium by fracturing it. It facilitates the treatment of calcific disease by supporting both antero- and retrograde access. The estimated particle size is approximately 2 μm, as it has to be smaller than the size of a leukocyte or an erythrocyte in order to effectively minimize the risk of distal embolization during and after the procedure.
Efficacy and safety
The results of CALCIUM 360 and COMPLIANCE 360 studies showed that Stealth 360 Percutaneous Orbital Atherectomy System (POAS) safely and effectively reduces atheroma burden in a clinical setting, which translates into the use of lower maximum mean balloon inflation pressures (OAS + PTA) vs. PTA only.
Possible time and cost savings
The benefits in terms of costs are associated with reduced hospitalization periods and lower revascularization rates. The system also allows for saving time as it facilitates operating in tortuous, tight and severely calcified vessels without the need of exchanging the workhorse/guide wire. After performing orbital atherectomy, the procedure may be completed over the same guidewire.
Easy and convenient to use
Preparing the system for the procedure takes around 2 minutes. The user may choose one of three programmed rotation speeds without the risk of deceleration. The guidewire guarantees solid support and confidence during the introduction of subsequent devices.