The data presented by the company reinforces the durability, safety, and effectiveness of the IN.PACT Admiral drug-coated balloon in patients with peripheral artery disease (PAD) in the superficial femoral (SFA) and popliteal arteries.
The Kaplan-Meier estimate was 74.5% in the DCB group compared to 65.3 in the PTA group.
Long-term safety benefits of IN.PACT Admiral was also demonstrated with low rates of major target limb amputation (0.5%) and thrombosis (2.2%) in the IN.PACT Admiral DCB arm, and no device or procedure-related deaths through five years in both the IN.PACT Admiral DCB and PTA arms.
The data showed that IN.PACT Admiral DCB demonstrated consistently superior safety and freedom from clinically-driven target lesion revascularization (CD-TLR) compared to standard PTA alone.
The all-subjects analysis assessed all 1,837 DCB and 143 PTA subjects from across IN.PACT Admiral clinical programs, including IN.PACT SFA, IN.PACT Global, IN.PACT SFA Japan, and IN.PACT SFA China studies.
IN.PACT Admiral drug-coated balloon outperformed the PTA control arm in freedom from CD-TLR with a Kaplan-Meier estimate of 93.8% in the DCB group compared to 80.2% in the PTA group (log-rank p<0.001).
Additional safety and effectiveness outcomes from the DCB arm also included low rates of thrombosis (2.5%), major target limb amputation (0.2%), and all-cause mortality (3.1%) through one-year in a large PAD patient population.
The data from the all-subjects analysis also confirmed IN.PACT Admiral DCB’s superior safety and freedom from reintervention rate at one year, while providing key information to help improve treatment decisions.
Medtronic Cardiac & Vascular Group vice president and general manager of the Peripheral business Mark Pacyna said since the entrance of DCBs into the market several years ago, a shift was seen towards the use of this technology as a frontline therapy to treat patients with PAD.
“We believe this new evidence will give physicians the confidence that IN.PACT Admiral DCB is the preferred first line therapy for patients who suffer with femoral-popliteal disease.”
