(RxWiki News) Peripheral artery disease (PAD) can be treated by several methods depending on severity of the leg blockage. Bypass surgery in the leg is one option, but less-invasive endovascular surgery is preferred when appropriate.
Researchers have found success in improving leg blood flow with the ENABLER-P Balloon Catheter System, which is minimally invasive and requires only about five minutes for the actual plaque clearing procedure.
"Try exercise to improve PAD symptoms."
Thomas Zeller, MD, from University Hospital of Freiburg's Heart Center in Germany, found that most patients in the small study were successfully treated with the device. Though the trial was small, this marked the first the first time safety and effectiveness of the device had been tested in humans.
The patients who participated in the trial had moderate to severe plaque build up in arteries in their legs.
During the APOLO study 37 chronic PAD patients, including those with heavily calcified, long, and fibrotic lesions, received treatment from the ENABLER-P Balloon Catheter System at three sites in Germany, Brazil and Israel. Most were men and the average patient age was 67. About 40 percent of the patients smoked and 30 percent had diabetes, both risk factors for PAD. About 21 percent of participants had previous conventional guidewire attempts or failed angioplasty attempts.
The system has a unique balloon-anchoring mechanism and an automated balloon inflation device that allows a guidewire to steadily advance through an occlusion through increased top force.
It is similar to balloon angioplasty, however, some of its advanced features may make the system more efficient for treating more severe PAD cases to restore flood flow.
Investigators found that 86 percent, or 32 patients, were successfully and safely treatment with the system. Although the system was unsuccessful in five patients, three of those patients were successfully treated after a second attempt. Of the successful 32 patients, all but one patient had blood flow restored.
The study was recently published in the Journal of Endovascular Therapy.