Dr. Mannava, First Physician in Ohio to use Stealth 360º™ Orbital PAD System from Cardiovascular Systems to Treat Peripheral Arterial Disease
LANCASTER, Ohio (June 21, 2011) – Dr. Krishna Mannava, Vascular Surgeon at Fairfield Medical Center (FMC), is the first physician in Ohio and at Fairfield Medical Center to use the Cardiovascular Systems’ (CSI) Stealth 360°™ Orbital PAD System, a new option for millions of people in the United States who suffer from the debilitating effects of peripheral arterial disease (PAD).
From left, Dr. Mannava, Vascular and Endovascular Surgeon, and Dr. Barboza, Vascular and Interventional Radiologist, using the Stealth 360º™ technology.
In this life-threatening condition, plaque builds up on the inside walls of blood vessels, reducing blood flow to the legs and arms, eventually leading to non-healing wounds and possibly amputation.
“The Stealth 360° is as fast and easy to use as a balloon or stent, but is a safer alternative,” said Dr. Mannava. “The device allows physicians to use lower speeds and have more control during the procedure. It also provides effective treatment for the entire leg, including small calcified vessels below the knee that are critical to achieving blood flow to the foot.” As a physician dedicated to medical advances to improve the odds for patients with PAD, Dr. Mannava has treated many patients at Fairfield Medical Center and is very dedicated to improving the lives of his patients.
"Physicians told us they needed improved, safe and effective options to treat PAD,” said David L. Martin, president and chief executive officer of Cardiovascular Systems. “The Stealth 360° provides physicians a clinically proven, easy-to-use, front-line treatment for routine and complex PAD cases. We believe these innovations will encourage more physicians to adopt our technology to treat lesions from hip to toe, including the most difficult blockages below the knee."
CSI manufactures the Stealth 360°, which received Food and Drug Administration 510(k) marketing clearance in March 2011. The system utilizes CSI's proven orbital mechanism of action that protects healthy vessel tissue while removing even the most difficult-to-treat plaque. An off-set, diamond-coated “crown” sands away the plaque. As the crown rotates and orbit increases, centrifugal force action presses the crown against the lesion or plaque, removing a small amount of plaque with each orbit. The orbital motion is designed to create a smooth vessel opening or lumen, which may improve blood flow. Preliminary results in nearly 800 lesions from CSI's Confirm II Predator clinical study demonstrate that the crown is designed for maximal plaque removal at lower speeds in the shortest amount of time. The shaft is flexible and suited for compromised run-off, vessel bends or tortuous anatomy.
Following the FDA marketing clearance, CSI has released the Stealth 360º in limited markets to generate valuable feedback from physicians, establish best practices for device operation and provide a smooth transition to the new platform.
To view Stealth 360° images and an animation, visit: http://bizwire.pr/vOx1I.
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