BRADENTON — Two Bradenton residents are the first in the United States to try out a new Japanese medical device that helps physicians treat restricted blood flow in the leg.
Dr. Srinivas Iyengar implanted MISAGO stents in the legs of patients suffering from peripheral arterial disease, or PAD, during the past week at Bradenton Cardiology Center as part of a joint clinical study under way in the United States and Japan.
Iyengar said the stent, made of a nickel and titanium alloy, is more flexible and durable than stents used to open diseased arteries in the past. It is inserted with a catheter around a narrowed area of the superficial femoral artery, which is responsible for transporting most of the blood that circulates in the legs and feet.
“It is exciting new research that is being undertaken here,” said the 37-year-old Iyengar, an interventional cardiologist who has been with Bradenton Cardiology for just more than a year.
“Every time a new technology comes out, it doesn’t mean it’s better. But we’re hoping it is. That’s our hypothesis, that this is going to make patients’ leg (arteries) stay open longer.”
According to the American Heart Association, PAD affects about 8 million Americans and becomes more common as people age. Those who suffer from PAD typically experience cramping, pain or fatigue in the leg or hip muscles when walking or climbing stairs.
The condition has gained attention recently in advertising for the blood thinner Plavix.
“PAD is a very under-recognized condition in this country right now,” Iyengar said. “We try to implore the patient that, ‘Yes, your heart may hurt, but what is it about your legs when you walk up a flight of stairs?’
“The risk of heart disease and stroke multiplies if you have PAD. The commercials don’t lie. I’m not telling anyone to be on Plavix or any other medication, but it is true.”
Iyengar said patients who have the stent implanted recover in one to two hours and see immediate results.
He said traditional PAD treatment involved bypass surgery, but such procedures carried a high risk of infection or death. Within the past 20 years, cardiologists have turned to less invasive procedures that involve stents.
While the MISAGO stent, marketed by the U.S. subsidiary of the Tokyo-based Terumo Medical Corp., is not the first used for PAD treatment, Inyengar said it shows promise. It is a self-expanding stent, which means it doesn’t require a balloon to be inserted with it and is less likely to perforate an artery.
Terumo’s U.S. General Manager James Rushworth said the new stent’s rapid-exchange delivery system is novel because it allows one physician to control the catheter more easily. Other stent delivery procedures require at least two physicians, he said.
“What that does is bring a new level of efficiency to the procedure,” Rushworth said.
Bradenton Cardiology is one of 30 sites across the country — highly respected Columbia University, Johns Hopkins and Massachusetts General are among the others — to participate in the study, but its procedures occurred first.
A total of 350 patients in the United States and Japan will be treated in the study, which aims for joint approval from the Food and Drug Administration and the Japanese regulatory agency.
Iyengar, who served a two-year fellowship at Columbia after a residency at Ohio State University, became part of the study after a referral from his mentor at Columbia, Dr. William Gray. Iyengar said medical companies are interested in Manatee and Sarasota counties because of their older populations.
“What we were looking for is not necessarily to go to the big-name sites,” Rushworth said. “We chose places like Bradenton because of the quality of care provided there and the volume of patients they see there.”
Bradenton Cardiology is seeking about 15 more patients for its part of the study. If you think you are suffering from PAD, call Bradenton Cardiology at (941) 742-6378 for more information about joining the study.