Medtronic Inc. recently developed an innovative experimental medical device, the IN.PACT Admiral drug-coated balloon for the treatment of peripheral artery disease in leg arteries above the knee, providing a promising treatment for patients with diabetes, which is currently under review for approval by the U.S. Food and Drug Administration (FDA).
In the United States and Western Europe, 650 to 700 hundred people undergo an interventional procedure every year that involves the superficial femoral artery (SFA). Medtronic Inc. (www.medtronic.com) in collaboration with top clinicians, investigators, and scientists, provides a wide range of innovative medical technology for the interventional and surgical therapies of cardiovascular diseases and cardiac arrhythmias.
The IN.PACT Admiral drug-coated balloon medical device was evaluated in the IN.PACT SFA Trial. This trial recruited 331 subjects from 57 locations across Europe and the United States, which were randomized to treatment with the drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA), a minimal invasive procedure to unblock coronary arteries. The majority of the patients — around 95% — had moderate or severe claudication, a condition characterized by leg pain while walking due to diminished blood flow by the superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the remaining 5% of participants suffered from rest pain due to advanced arterial disease. In addition to these conditions, other diseases such as diabetes and hypertension were similar, with no statistically significant differences between the two groups. The clinical outcomes significantly favored the drug-coated balloon (DCB) group. The main findings from the IN.PACT SFA Trial were presented in April 2014 at the 36Th Charing Cross International Symposium in London and will be published in a peer-reviewed medical journal.
“Peripheral artery disease in patients with diabetes tends to be more advanced and complex and as a result more challenging to treat than it is in patients without diabetes” explained Dr. Schneider, a principal investigator of the IN.PACT SFA Trial, in the press release. “While that tendency held true in this study diabetes did not negate the magnitude of the difference in treatment effect. The potency rates were statistically significantly higher by more than 20 percent for all patients in the drug-coated balloon arm and for its diabetic patient subset.”
In 2009 the IN.PACT Admiral drug-coated balloon received the CE (Conformité Européene) approval and since then has been used as standard clinical practice in Europe.