On the heels of starting American trials for its drug-eluting balloon, Medtronic ($MDT) is taking studies of thr delivery device global. The company announced that it will begin worldwide trials for its IN.PACT Admiral drug-eluting balloon, which is designed to treat peripheral artery disease.
The balloon is designed to treat atherosclerotic disease in the superficial femoral or popliteal arteries by releasing treatment into the arteries to help revascularize lesions caused by the disease. The study will enroll up to 1,500 "real world" patients in numerous countries around the world, researchers said in a release, and is just another step in Medtronic's path to get the delivery device on the market. The company plans 24 total studies with 4,000 patients from up to 80 countries, and Medtronic will use the results to support a premarket approval application to the FDA.
Last month, the Journal of the American College of Cardiology published results of a study of the balloon's impact, finding an 83.7% primary patency rate and a 7.6% target lesion revascularization rate among its 105 patients. The study also found significant quality-of-life improvements among patients.
Peripheral artery disease affects about 12 million people worldwide, according to a Medtronic release, and its incidence in the lower extremities can lead to immobility, critical limb ischemia and amputations. But Admiral's early positive results and novel delivery show promise for effectively treating the disease, said John Laird, a UC-Davis medical professor involved in the study.
"Drug-eluting balloons represent an exciting and innovative therapy in the advancement of peripheral artery disease treatment," Laird said in a release. "The concept of delivering an anti-restenotic agent to the vessel while leaving nothing behind is very attractive."
- check out Medtronic's release
- read FierceMedicalDevices' report