The Food and Drug Administration has approved the device, Proteus®, made by Angioslide, for angioplasties that treat peripheral artery disease (PAD) in the legs. PAD is caused by clogged arteries that restrict blood flow to the legs. Symptoms include painful cramping in the hips, thighs or calves when walking, climbing stairs or exercising. Advanced PAD can cause gangrene or even lead to limb loss.
A balloon angioplasty is among the standard treatments for PAD. A physician inserts a catheter in an artery and guides it to the blockage, then opens the artery by inflating a balloon at the tip of the catheter. The physician typically deploys a stent to keep the artery open.
Inflating the balloon can loosen particles of plaque, which travel down the leg. A large particle can block blood flow, a condition called distal embolization. In the most severe cases, distal embolizations can require leg amputation or even be fatal.
Until now, some physicians have used a filter device to prevent debris from escaping. However, the filter can damage the artery, and can be difficult to deploy. Moreover the FDA has not approved filter devices for use in leg arteries. Using filters for PAD procedures, although routine, must be done “off label.”
The new device that Dieter uses opens the artery just like a standard angioplasty balloon. After the artery is opened, the physician deflates the balloon. The negative pressure sucks up the debris, which is trapped inside as the balloon retracts.
“This is a much more simple and elegant approach than filter devices,” said Dieter, an interventional cardiologist and vascular specialist.
Dieter is an assistant professor in the Department of Medicine, Division of Cardiology at Loyola University Chicago Stritch School of Medicine and director of Vascular Medicine and peripheral Vascular Interventions at Edward Hines VA Hospital. Dieter has used the device on patients at Loyola and Hines.
His first Loyola patient was Patricia Durkin of Oak Forest, Ill. Before the procedure, the top of the iliac artery that supplies blood to her left leg was 90 percent blocked. “If I walked in the mall, I had to stop every few minutes,” she said. “It made my leg feel heavy. It got to the point where I didn’t want to walk any distance.”
The procedure restored normal blood flow. “I don’t have that heavy feeling anymore,” Durkin said.
Other interventional cardiologists at Loyola also plan to use the device, said Dr. John Lopez, director of Interventional Cardiology Research and professor in the Department of Medicine, Division of Cardiology.
“At Loyola, interventional cardiology is very progressive, and at the forefront of technology for the treatment of PAD,” Lopez said.
Based in the western suburbs of Chicago, Loyola University Health System is a quaternary care system with a 61-acre main medical center campus, the 36-acre Gottlieb Memorial Hospital campus and 25 primary and specialty care facilities in Cook, Will and DuPage counties. The medical center campus is conveniently located in Maywood, 13 miles west of the Chicago Loop and 8 miles east of Oak Brook, Ill. The heart of the medical center campus, Loyola University Hospital, is a 569-licensed-bed facility. It houses a Level 1 Trauma Center, a Burn Center and the Ronald McDonald® Children’s Hospital of Loyola University Medical Center. Also on campus are the Cardinal Bernardin Cancer Center, Loyola Outpatient Center, Center for Heart & Vascular Medicine and Loyola Oral Health Center as well as the LUC Stritch School of Medicine, the LUC Marcella Niehoff School of Nursing and the Loyola Center for Fitness. Loyola’s Gottlieb campus in Melrose Park includes the 274-licensed-bed community hospital, the Professional Office Building housing 150 private practice clinics, the Adult Day Care, the Gottlieb Center for Fitness and Marjorie G. Weinberg Cancer Care Center.