St. Joseph Hospital Among First in State to Use New Medical Device to Treat Vascular and Arterial Diseases

Louis Lopez, MD, among first in U. S. to use device

FORT WAYNE, IND. (Dec. 24, 2007) — St. Joseph Hospital is among an elite group bringing the latest medical technology to Indiana with a device approved by the FDA in early September. Louis Lopez, MD, was one of five physicians in the country to first use the new device to treat patients with blocked arteries, diabetes and any vascular diseases including Peripheral Arterial Disease.

The outpatient, catheter procedure, known as orbital atherectomy, requires entrance through the femoral artery. The oscillating sander allows the physician access to the smaller vessels below-the-knee; it grinds away plaque and restores blood flow to the artery before it becomes limb- or life-threatening. The device allows for a complete, even sanding of the lumen on the inside of the artery wall, which results in less clotting.

More than 12 million people in the U.S. suffer from PAD, which can cause debilitating pain in the legs. It is estimated that fewer than two million people are actually diagnosed with PAD, but less than 700,000 are treated each year.

As advancements in technology progress, so too does the quality care patients receive and the ease with which the care is administered by medical professionals. Yet, 150,000 legs are amputated in the United States annually. Half of those amputated are not referred for alternative treatment prior to amputation. That trend is one Lopez hopes to reverse with this technology and through increased awareness.

"I'm very excited to be bringing this technology in vascular care to St. Joe," Lopez said. "The benefit of this particular device for atherectomy procedures below the knee is that it rotates and breaks up the plaque to microscopic size, much smaller than a red blood cell."

"We're producing some of the largest volumes in vascular work in the area here at St. Joseph Hospital," said Kirk Ray, president and CEO of St. Joseph Hospital. "There's a limited number of doctors who do below the knee procedures in town, and we're fortunate to have one of the forerunners right here."

The device differs from existing atherectomy technologies in its ability to remove hard, calcified plaque by using a unique orbital mechanism of action. A diamond-coated offset crown uses the principals of centrifugal force to "orbit" and sand away plaque, while preserving the healthy tissue of the arterial wall.

Having used the Diamondback 360 device in more than 700 cases since September, Lopez is pleased with aspects of the new device.

"It's effective at sanding away the calcified plaque and does not seem to have an effect on the healthy tissue, so it doesn't perforate the artery, thus making it safer," said Lopez.

The physician benefit of the new device is that it reduces the procedure time and a reduction in the number of devices needed.

Lopez explained that orbital atherectomy is a great alternative to by-pass graph surgery because it is an outpatient procedure with a brief recovery time. It prevents amputation and improves quality of life for patients by restoring mobility and healing wounds.

"Plans are to have 20 sites in the United States for a clinical trial initially," Lopez said. "St. Joe will participate in the trial study and eventually become a teaching site for the procedure."

Graphics and animation of the Diamondback 360 device are available to the media upon request.

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