Medtronic plc Announces New Data Shared on IN.PACT Admiral DCB Drug-Coated Balloon in Patients with Peripheral Artery Disease
January 22, 2019 at 07:00 am EST
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Medtronic plc announced new data shared on the IN.PACT Admiral(TM) drug-coated balloon (DCB) in patients with peripheral artery disease (PAD) in the superficial
femoral (SFA) and popliteal arteries. Outcomes from the IN.PACT DCB Paclitaxel Safety Analysis, an independent, patient-level survival analysis inclusive of all IN.PACT DCB clinical programs, were presented at the Leipzig Interventional Course (LINC) in Leipzig, Germany. A manuscript detailing outcomes from the IN.PACT DCB Paclitaxel Safety analysis was also accepted and is in press with the Journal of the American College of Cardiology (JACC). At five years there was no statistically significant difference in all-cause mortality between the DCB and plain balloon angioplasty (PTA) arms (9.3% versus 11.2% respectively, p=0.399.Data found no correlation between paclitaxel dose and long-term survival. Patients treated in the DCB arm were classified by upper, mid, and lower dose ranges. Freedom from all-cause mortality based on Kaplan-Meier estimates was 91.7% in the upper range, 90.6 in the mid-range, and 90.0% in the lower range (p=0.700). Data demonstrated no difference in mean nominal dose of paclitaxel between overall survival in patients treated with DCB (n=1,696) and those who died (n=140). Mean nominal paclitaxel doses were 11,829.8ug +/- 7,347.6ug and 11,419.6ug +/- 7,414.8ug respectively (p=0.529). The analysis evaluated all-cause mortality across IN.PACT studies. This included device- or procedure-related death through five years and paclitaxel-related events through 12 months. Upon review of other endovascular therapies in published literature, it was found that the mortality rates across IN.PACT DCB studies are comparable to or lower than what would be expected in similar patient populations. (1-5) Authors also found no significant difference between nominal dose in those with overall survival through five years. Furthermore, patients who died were older and shared a statistically higher level of co-morbidities at baseline, including coronary artery disease, diabetes, and chronic kidney disease, versus those with higher overall survival rates. Across all studies, results were reviewed and adjudicated by an independent clinica vents committee.
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%).
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