Orbital Device Minimizes Endarterectomy Procedure Time

A catheter-based system uses an orbital technology to treat peripheral arterial disease (PAD) by sanding away plaque buildup without damaging the soft arterial tissue.

The Stealth 360° Orbital PAD System is intended to treat calcified and fibrotic plaque in arterial vessels by endarterectomy throughout the leg, in only a few minutes of treatment time. The system is based on an orbital mechanism of action that protects healthy tissue, while removing even the most difficult to treat plaque. The electrical-powered handle features a power button and speed selection controls that are conveniently positioned for ease of use and greater physician control. The crown is designed for maximal plaque removal at lower speeds, and the flexible shaft is well suited for compromised run-off, vessel bends, or tortuous anatomy. The orbital system operates by centrifugal force, which causes the crown to orbit at the same time as it advances through the lesion.


As the crown rotation increases, centrifugal force presses the crown against the plaque and sands it into tiny particles with each orbit. More than 99% of the particles are smaller than a red blood cell (RBC), and they are washed away with the patient's blood flow. The elastic, more compliant tissue flexes away from the crown and leaves the nondiseased tissue intact. By removing the hardened plaque and changing the compliance of the lesion first, low-pressure balloon angioplasty can be used to finish the procedure, which may reduce the potential for barotrauma to the vessel. The result of the procedure is a smooth, concentric, and open vessel that appears to be a normal size and allows robust blood flow. The Stealth 360° Orbital PAD System is a product of Cardiovascular Systems (CSI; St. Paul, MN, USA), and has been approved by the US Food and Drug Administration (FDA).

"The new Stealth 360° is as fast and easy to set up as a balloon or stent, but safer and more durable,” said Jihad Mustapha, MD, an interventional cardiologist at Metro Health Hospital (Grand Rapids, MI, USA), who treated the first patient with the Stealth 360°. "This device provides effective treatment for the entire leg, including small calcified vessels below the knee that are critical to achieving blood flow to the foot.”

PAD is a narrowing of the peripheral arteries due to atherosclerosis, and is most common in the arteries of the pelvis and legs. The most common symptoms of PAD are cramping, pain, or tiredness in the leg or hip muscles while walking or climbing stairs, which is temporarily relieved by rest. PAD sufferers have four to five times more risk of heart attack or stroke, and if left untreated, it can lead to gangrene and amputation.

Related Links:
Cardiovascular Systems
Metro Health Hospital