Medtronic Plc's IN.PACT Admiral Demonstrates Consistent and Durable Outcomes in New Two-Year Japan Data and In.Pact Global Critical Limb Ischemia Cohort Analysis
January 30, 2018 at 08:28 am EST
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Medtronic plc added to its robust body of clinical evidence supporting the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) with new presentations that demonstrated durable and consistent clinical outcomes in peripheral artery disease (PAD). The new data presented at the Leipzig Interventional Course (LINC) in Leipzig, Germany, included the two-year results from the MDT-2113 study (IN.PACT SFA Japan) and data from a critical limb ischemia (CLI) subgroup analysis from the IN.PACT Global Study. Two-Year Japan Data - New data from the IN.PACT SFA Japan Study were presented by Osamu Iida, M.D., Kansai Rosai Hospital, Japan. The study enrolled 100 patients across 11 sites in Japan and randomized treatment to either DCB (n=68) or plain balloon angioplasty (PTA) (n=32). The results were consistent with two-year findings from the pivotal IN.PACT SFA Study, showing a low clinically-driven target lesion revascularization (CD-TLR) rate and high patency rate. IN.PACT Admiral SFA Japan demonstrated 79.8% primary patency in the DCB group as compared to 46.9% in the PTA group at two years based on Kaplan- Meier Estimate (p<0.001). The two-year results also demonstrated a CD-TLR rate of 9.1% for the DCB group compared to 20.7% in the PTA group (p=0.177) and a freedom from CD-TLR based on Kaplan-Meier Estimate of 90.8 for the DCB group compared to 81.3% in the PTA group (p=0.114). In IN.PACT SFA Japan, major adverse events were also lower for the DCB at two years (15.2% compared to 24.1% in the PTA group; p=0.384), with no major target limb amputations. There were no additional safety concerns at two years. Today's announcement follows the recent approval of IN.PACT Admiral from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of peripheral artery disease (PAD) in the upper leg - specifically, in the thigh (superficial femoral arteries (SFA)) and behind the knee (popliteal arteries). The MHLW also granted reimbursement approval for the IN.PACT Admiral in December of 2017. IN.PACT Admiral is expected to commercially launch in Japan after completing the conditions associated with Shonin approval.
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).
Medtronic Plc's IN.PACT Admiral Demonstrates Consistent and Durable Outcomes in New Two-Year Japan Data and In.Pact Global Critical Limb Ischemia Cohort Analysis