Medtronic (NYSE:MDT) touted data today for its In.Pact Admiral drug-coated balloon in 2 sub-analyses of peripheral artery disease patients in the company’s In.Pact Global Study. The data were presented at the 2017 Charing Cross Symposium in London.
Researchers presented 1-year outcomes in patients with complex lesions, as well as outcomes in a subset of patients with complex, calcified lesions.
The 1st analysis examined outcomes in standard usage patients with single lesions less than or equal to 18 centimeters compared to use in a broader spectrum of patients with bilateral/multiple lesions and moderate-to-severe calcification. Results were consistent at 1 year for both groups, with comparable clinically-driven target lesion revascularization. CD-TLR for the subset with complex lesions was 8.5%, which was consistent with the full clinical cohort of the In.Pact Global Study.
Results for the primary safety endpoint were consistent across cohorts, according to Medtronic.
“These sub-analyses show that In.Pact Admiral continues to deliver durable and consistent results across our more typically treated patient populations,” OhioHealth Riverside Methodist Hospital’s system medical director for vascular services, Dr. Gary Ansel, said in prepared remarks. “Notably, the data in this study highlight that the In.Pact Admiral DCB can be safe and effective when used in our patients with complex PAD, such as those with challenging calcified lesions and with significant co-morbidities.”
In the 2nd analysis, researchers examined a subset of patients with complex, calcified lesions from the long lesion and chronic total occlusion imaging cohort of the global study.
The subset included long lesion and CTO patients defined as having moderate-to-severely calcified lesions. After 1 year, patients achieved primary patency rates of 88.8% and a CD-TLR rate of 8.5%. Provisional stenting occurred in more than 50% of patients
“Through our investments in the In.Pact clinical program and ongoing studies, Medtronic is committed to partnering with clinicians to develop evidence-based treatments for complex PAD,” Mark Pacyna, GM of the Medtronic’s peripheral business, said. “The adoption of In.Pact Admiral as a frontline treatment option has been driven by its unparalleled clinical profile, which continues to demonstrate durability, safety, and efficacy across PAD patient populations.”