November 6, 2020

5-Year Data From IN.PACT Global Study Show Sustained Safety and Efficacy for Medtronic’s In.Pact Admiral DCB

November 6, 2020—Five-year data from the IN.PACT Global study evaluated the real-world performance of the In.Pact Admiral drug-coated balloon (DCB) in patients with peripheral artery disease in the superficial femoral and popliteal arteries.

Professor Thomas Zeller, MD, who is Director of the Department of Angiology at Universitaets-Herzzentrum, Freiburg-Bad Krozingen, Germany, presented the findings in a late-breaking clinical trials session at VIVA 2020, the Vascular InterVentional Advances annual meeting held as a virtual congress November 6-8, 2020.

According to the VIVA announcement of the presentation, the IN.PACT Global Study was a large, prospective, multicenter, single-arm study conducted at 64 international sites. The study enrolled patients with bilateral disease; multiple lesions (de novo or restenotic); TASC A, B, C, or D; in-stent restenosis; long lesions (≥ 15 cm); and chronic total occlusions (≥ 5 cm).

In the study, 1,406 intention-to-treat patients with 1,774 target lesions were treated with the In.Pact Admiral DCB and analyzed as a part of the consecutively enrolled clinical cohort with safety and revascularization events reviewed by an independent clinical events committee.

The mean lesion length in this clinical cohort was 12.10 ± 9.54 cm, with 18% in-stent restenosis, 35.5% total occlusions, and 68.7% calcification.

Assessments through 5 years using Kaplan-Meier (K-M) estimates included freedom from clinically driven target lesion revascularization (CD-TLR), a safety composite (freedom from device- and procedure-related mortality through 30 days; freedom from major target limb amputation through 5 years; and clinically driven target vessel revascularization through 5 years), and all-cause death.

The investigators reported the following findings via K-M estimates through 5 years:

  • Freedom from CD-TLR was 69.4%.
  • The primary safety composite endpoint was 67.4% with a low major target limb amputation cumulative incidence of 1.7%.
  • The all-cause death rate was 78.9%, which was calculated after 96.4% vital status follow-up was collected through 5 years

The study showed that since the results of this real-world study were first published, safety and effectiveness through 5 years have been sustained. These outcomes support the use of the In.Pact Admiral DCB for the management of real-world patients including complex femoropopliteal artery lesions, concluded the investigators in the VIVA press release.


November 6, 2020

Directional Atherectomy Vessel Preparation Before DCB Angioplasty Evaluated in REALITY

November 6, 2020

Vascular Barcelona’s Varixio and CrabClamp Platforms Gain CE Mark Approval