New device permits less invasive approach to leg surgery

July 24, 1997

The University of Chicago Hospitals is one of three medical centers in the United States using a new device, developed by Baxter Healthcare Corporation, to restore blood flow to the leg for patients with advanced peripheral vascular disease, the leading cause of amputations in the United States.

The device, which received 510(k) marketing approval from the U.S. Food and Drug Administration in June, permits the operation to be performed from within the vein, eliminating the need for a groin-to-calf incision, decreasing patient pain and lowering costs.

"The minimally invasive approach makes this operation much easier for the patient," said Giancarlo Piano, MD, assistant professor of surgery at the University of Chicago. "By drastically decreasing the size of the surgical incision, it decreases the frequency and severity of wound complications, shortens hospital stays, and gets patients back on their feet much more quickly."

Each year, more than 100,000 patients undergo peripheral bypass surgery to restore blood flow to the leg. The traditional operation involves removing the saphenous vein, which extends from the groin to the ankle along the inside of the leg. The surgeon then ties off the side branches of the vein, and returns the entire vein to the leg but re-connects it in reverse, so that blood can flow down toward the ankle and foot rather than up from the foot back toward the heart.

The Baxter Side Branch Occlusion System(TM), lets surgeons avoid this long incision in the leg by allowing them to work inside the vessel from two small incisions, one in the groin area and another in the ankle. An angioscope provides a view within the vessel. A tiny device called a valvulotome disrupts the one-way valves that ordinarily prevent blood from flowing back down the vein. And the surgeons use a small catheter to deposit tiny stainless-steel coils into each side branch, closing them. "Patients treated with minimally invasive surgery tend to leave the hospital in two or three days rather that a week, which was common with the traditional operation," said Piano. "The newer approach also avoids the unsightly scarring and considerable pain associated with the longer incision."

Physicians from the three medical centers that performed the clinical trials of the device--University of Chicago Hospitals, Georgia Baptist Medical Center, and Montgomery General Hospital--will begin training courses for other surgeons this August, making the procedure more widely available.

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