Irish medical technology firm Medtronic has presented new clinical data of IN.PACT Admiral drug-coated balloon (DCB) from two different studies at EuroPCR.
According to the company, the studies demonstrated that drug-coated balloon successfully treated long lesions in the superficial femoral and popliteal arteries.
In December 2014, the IN.PACT Admiral DCB obtained approval from the US Food and Drug Administration (FDA) for percutaneous transluminal angioplasty (PTA), after pre-dilitation, of de novo or restenotic lesions up to 18cm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7mm.
It also received CE mark approval in 2009 for PTA in patients with obstructive disease of peripheral arteries.
The company presented 12-month results for 157 patients enrolled in the IN.PACT Global Study’s long lesion imaging cohort.
The patients from the trial had a total of 164 lesions of at least 15cm in length, and the IN.PACT Admiral DCB delivered better outcomes at 12 months, including 6% rate of clinically-driven target lesion revascularization (CD-TLR) and primary patency of 91.1%.
IN.PACT Global Study investigator professor Scheiner said: "For patients with peripheral arterial disease in the lower extremities, long lesions pose a notoriously difficult treatment challenge."
The study had enrolled more than 1,500 patients at 64 sites across the globe to characterize the performance of the IN.PACT Admiral DCB in the context of routine clinical practice.
The DEB SFA-LONG study, which is the other trial of IN.PACT Admiral DCB, had enrolled 105 patients with an average lesion length of 25.2cm, at six sites in Italy.
Medtronic has presented 12-month results of the study that were consistent with those from the long-lesion subset of the IN.PACT Global Study’s imaging cohort. The CD-TLR rate in this independent and multicenter Italian study was 4% and primary patency was 89.3%.
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.