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FDA approves DCB to treat PAD in upper leg
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Medtronic announced that the FDA has approved its IN.PACT Admiral drug-coated balloon for treatment of peripheral artery disease in the upper leg.
The DCB is designed to reopen superficial femoral and popliteal arteries that have been narrowed or blocked by plaque, and to keep them open by delivering paclitaxel to the artery walls, according to a Medtronic press release.
Michael R. Jaff
“The introduction of drug-coated balloons represents a significant breakthrough that might establish a new standard of care with its potential to change the way we treat peripheral artery disease in the leg,” Michael R. Jaff, DO, Paul and Phyllis Fireman Chair in Vascular Medicine at the Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in the release.
“Data from clinical trials evaluating this new drug-coated balloon have consistently demonstrated improved patient outcomes,” Jaff, an investigator in trials for the device and a member of the Cardiology Today Editorial Board, said.
According to the release, results from the IN.PACT SFA trial demonstrated the lowest rate of clinically driven target lesion revascularization at 1 year ever reported for an interventional treatment of PAD in the superficial femoral artery (DCB group, 2.4%; percutaneous transluminal angioplasty group, 20.6%), as well as the highest reported rates of primary patency at 1 year (DCB group, 82.2%; PTA group, 52.4%).
Perspective
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Subhash Banerjee, MD, FACC, FSCAI
I believe there are three important reasons why the approval of the IN.PACT Admiral DCB is going to change our clinical practice.
First, though individuals like myself have been practicing non–stent-based interventions for the lower extremities (superficial femoral, popliteal and below-the-knee arteries), there have not been devices and technologies that have provided the durability that we have been looking for. The overall 12-month clinically driven TLR rate of 2.4% with the IN.PACT DCB makes people more comfortable that finally there will be a way of providing long-term durability with a non-stent treatment option.
Second, there are drug-delivery devices in the way of stents, but these arteries are not always conducive to stent-based treatments.
Third, unlike many of the prior DCBs, this DCB has been studied in a wide variety of lesions. It was studied in patients with chronic total occlusions, which is a greatly complex lesion type.
There is skepticism about whether balloons will be the definitive treatment for long, complex lesions. The current study does not answer all the questions, but it certainly is a significant step in that direction. Also encouraging is that the bailout stenting rate for moderate-severity lesions in the study was very small, which suggests that this technology was associated with fewer acute treatment failures in addition to providing more durable longer-term results. The IN.PACT DCB global study, which has enrolled a far more complex group of patients, is something that people are also going to look at very closely.
Most patients enrolled in studies of the IN.PACT DCB have been Rutherford Category 2 or 3, so it has primarily been studied in patients with claudication. There has also been some, albeit limited, representation of critical limb ischemia, and advanced Rutherford Category 5 patients have been underrepresented. Registry data, both from Europe and the United States, will be interesting, as they will indicate how clinicians really use these devices in clinical practice.
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