CSI Announces Approval for PAD Tool
The FDA approved the new Diamondback 260 Orbital Atherectomy System (OAS) for treating patients with peripheral arterial disease (PAD) requiring removal of blockage from the legs, manufactured by Cardiovascular Systems, Incorporated (CSI). CSI described the approval in a press release.
One advantage offered with the new product is its ability to remove calcified, hardened plaque. Removal of that and more common plaques is achieved with the device’s orbiting mechanism of action. The small crown, coated with diamonds, spins at a high rate of speed to sand away the plaque formations. The device is based on the principles of applied centrifugal force.
Simultaneously, the device is able to preserve the surrounding healthy tissues. The material that is sanded away is approximately 75 percent smaller than normal red blood cells. This eliminates the need to use a distal embolization protection device.
As well, the device is designed to be easy to use. Crown sizes can be changed quickly and easily. It is designed with ergonomic considerations. The Diamondback is available in a variety of sizes and, thus, suitable to treat a whole range of vessel diameters.
The value of the device is its ability to remove the hardened plaque formations, which is difficult to achieve with other products already available. The inability to achieve such has limited the number of patients eligible to undergo treatment to clear the peripheral arteries. More patients with PAD may now benefit from treatment accomplished with the Diamondback.
The company submitted a definitive study (the OASIS trial) to the FDA, results indicated that the system is successful in restoring blood flow to the affected artery, as well as having long lasting results. That study exceeded multiple outcomes that were predefined, including percentage of patients who did not require repeat procedures, the amount of plaque reduced, and the efficacy and safety of the overall device.
September 26, 2007 Related topics: Product Launches, Product Approval & Certification, Surgery, Cardiology