Date: 2/22/2007

Community Hospital is one of only 20 sites in the nation where a new, pre-FDA approved device for P.A.D. is being studied

MUNSTER -- Community Hospital is one of only 20 sites in the nation where a new, pre-FDA-approved device is being studied to help patients who are suffering severe leg pain and could even lose a limb from peripheral arterial disease (P.A.D.).

The research, led by Principal Investigator Prakash Makam, M.D., primarily focuses on helping patients who have blockages in the arteries below the knee. This new device, Cardiovascular Systems, Inc.’s Orbital Artherectomy System, provides new treatment options for symptomatic patients with narrowing or blockages in the arteries of the lower leg.

The research study called, “Orbital Artherectomy System Investigational Study (OASIS),” involves inserting a rotablator over a thin wire into the diseased artery. The rotablator has a diamond chip burr or end that rotates up to 200 rpms to pulverize the calcium, a very hard substance. The pulverized, tiny particles can travel through smaller arteries in the leg.

“This is a good application for hard calcium, especially for arteries below the knee,” said Makam, a cardiologist. “This is a feather in our cap to be selected to participate in this research. We were selected because of our experience and expertise.”

This technology has been used for heart blockage, but it is new for P.A.D, a condition that causes poor blood flow to the arms and legs. P.A.D. affects eight to 12 million Americans and, when left untreated, can progress into critical limb ischemia, resulting in amputation and death.

Over the past two years, there have been advancements in new treatments for P.A.D, and physicians at Community Hospital have been among the first to introduce many of them. SilverHawk and CLiRpath techniques are some of those new options.

Using the SilverHawk technique, a doctor shaves plaque from artery walls with a tiny blade the size of a grain of rice. A guide wire is threaded into the artery and the shaved plaque is pushed into a cone for collection.

With CLiRpath, a cool laser catheter delivers rapid, continual bursts of ultraviolet energy to the target site in the artery, eliminating or vaporizing the obstruction whether it is plaque, calcium or a clot.

A common procedure used for P.A.D. is balloon angioplasty. A balloon at the tip of a catheter is inflated inside the artery to block blood flow while a stent, a small wire mesh tube, is expanded inside the vessel to keep the walls open.

For more information on Community Healthcare System surgeons who treat P.A.D., call
219-836-3477 or toll-free 1-866-836-3477 or visit For more information on this research, call Community Healthcare System’s Foundation for Cardiovascular Research at

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