First Presentation of Results from Regional Cohorts of IN.PACT Global Study Reinforce Strong, Consistent and Safe Outcomes for PAD Patients
DUBLIN and LEIPZIG, Germany – Jan. 25, 2017 – Medtronic today presented new data at the Leipzig Interventional Course (LINC) 2017 conference supporting the IN.PACT® Admiral® drug-coated balloon (DCB) in patients with peripheral arterial disease (PAD). The real-world outcomes from regional cohorts of the IN.PACT Global Study in Asia and Belgium reinforce the strong efficacy and consistent outcomes of the IN.PACT Admiral DCB across multiple patient populations.
IN.PACT Global Study: Asian Subset
Donghoon Choi, M.D., from the division of cardiology at Severance Cardiovascular Hospital in South Korea presented one-year results from the Asian subset of the IN.PACT Global Study, including data from 114 patients at six sites in South Korea and Singapore. The results continue to underscore the positive performance in both safety and efficacy for the IN.PACT Admiral DCB in a broader set of complex patients with PAD.
In this subset analysis, the low clinically-driven target lesion revascularization (CD-TLR) at one year (3.8 percent) was consistent with the results in the complete cohort of 1,406 patients in the IN.PACT Global Study (7.5 percent). Results of the primary safety endpoint in the Asian cohort were also consistent with results from the full Global Study cohort, with 96.2 percent of patients achieving positive outcomes.
IN.PACT Global Study: Belgium
In a separate presentation of results from the IN.PACT Global Study, Koen Deloose, M.D., from the vascular surgery unit at AZ Sint Blasius, presented data on 305 patients from seven sites in Belgium. Belgium was the first country to enroll patients in the study and represents the largest enrolling country. At one year, patients experienced positive outcomes based on both efficacy and safety measures, consistent with overall findings from the IN.PACT Global Study.
In this patient subset, the low CD-TLR at one year (7.6 percent) was also consistent with the results in the complete cohort of patients in the IN.PACT Global Study (7.5 percent). Results of the primary safety endpoint in the Belgium cohort were also consistent with results from the full study, with 90.6 percent of patients achieving positive outcomes.
“The results from these two patient cohorts in Asia and Belgium support the unparalleled clinical evidence demonstrating the consistency, durability, and safety of the IN.PACT Admiral DCB,” said Mark Pacyna, general manager of the Peripheral business, which is part of the Aortic & Peripheral Vascular division at Medtronic. “We continue to invest in the IN.PACT clinical program to provide clinicians the broadest possible set of outcomes and measures of clinical rigor among multiple patient populations. We are pleased to present these data and further the body of clinical evidence supporting IN.PACT Admiral as a frontline treatment option globally.”
About IN.PACT Global Study
The IN.PACT Global Study is the largest and most rigorous post-market evaluation of any peripheral artery intervention ever undertaken. It has enrolled over 1,500 patients across 27 countries, including the 1,406 patients in the full clinical cohort, to characterize the performance of the IN.PACT Admiral DCB in treating real-world patients with challenging and complex lesions. The study included external monitoring and adjudication of events by an independent clinical events committee. Additionally, it included independent core lab evaluations for pre-specified imaging subsets for subjects with long lesions (>=15 cm) (n=157), chronic total occlusions (CTO) (>= 5 cm) (n=126) and in-stent restenosis (ISR) lesions (n=131), as recently presented at international conferences.
About IN.PACT Admiral Drug-Coated Balloon
The IN.PACT Admiral drug-coated balloon is a clinically-proven endovascular therapy indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of restenotic lesions with lengths up to 180 mm in superficial femoral or popliteal arteries with diameters of 4-7 mm.
To date, more than 200,000 patients have been treated with IN.PACT Admiral DCB.
Medtronic plc (www.medtronic.com (http://www.medtronic.com/)), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Krystin Hayward Leong
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Source: Medtronic plc via Globenewswire