Medtronic (NYSE:MDT) said today that it won FDA approval for 200mm and 250mm lengths of its In.Pact Admiral drug-coated balloon.
The newly-approved lengths are designed to treat patients with longer, more complex superficial femoral artery lesions, according to the medtech giant.
“As SFA disease progresses, we tend to see patients present with longer, more complex lesions. As a result, these lesions become incredibly challenging to treat and often require interventions with multiple technologies to effectively treat the entire segment,” said Dr. Gary Ansel, system medical director for vascular services at OhioHealth Riverside Methodist Hospital.
In April, Medtronic won FDA approval to treat superficial femoral artery lesions up to 360mm in length with the In.Pact Admiral product based on data from a 227-patient cohort. Clinical data from the complex lesion imaging group of Medtronic’s In.Pact Global study showed a one-year patency rate of 89.1% and a clinically-driven target revascularization rate of 7.1%.
“In our In.Pact Global Study, In.Pact Admiral demonstrated safety and effectiveness in real-world patients with complex lesions, including long lesions,” Mark Pacyna, VP & GM of Medtronic’s peripheral business, said in prepared remarks. “Our new long lesion indication – coupled with the approval of the 200mm and 250mm balloons -furthers our commitment to the clinical community by equipping them with the tools and evidence needed to effectively treat complex cases.”
