Medtronic Presents IN.PACT Global Study Three-Year Data

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Medtronic plc data announced continue to reinforce the safety, durability, and consistency of the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) in real-world patients with peripheral arterial disease (PAD). Three-year real-world results from the full clinical cohort of the IN.PACT Global Study and one-year data from the Total IN.PACT(TM) pooled imaging and propensity analyses were presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meeting and the 30th Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation, respectively.

“The two datasets presented at TCT and CIRSE are testaments to the breadth and depth of our IN.PACT Admiral clinical program. We are committed to providing the clinical community with timely and transparent access to data to better inform their treatment decisions,” said Mark Pacyna, vice president and general manager of the Peripheral business, which is part of the Aortic, Peripheral, and Venous division at Medtronic. “Consistently across trials, IN.PACT Admiral has demonstrated its ability to treat varying PAD patient populations, while effectively preserving future treatment options.”

IN.PACT Global Study: Three-Year Results Show Durability of Treatment Effect in Real-World Population

Professor Gunnar Tepe, M.D., director of Diagnostic and Interventional Radiology at the Academic Hospital RoMed Clinic in Rosenheim, Germany, presented the new, three-year results from the full clinical cohort of the IN.PACT Global Study. The results are the first three-year, real-world, fully adjudicated DCB data to be presented in a scientific congress and showed durability of treatment effect in a real-world population.

The freedom from clinically-driven target lesion revascularization (CD-TLR) rate calculated using Kaplan Meier survival estimates was 76.9 percent in a real-world patient cohort with a mean lesion length of 12.09 ± 9.54 cm, 18.0 percent in-stent restenosis, 35.5 percent occluded lesions, and 39.9 percent diabetic subjects. Additionally, the proportion of patients undergoing repeat procedures were low through three years:  major target limb amputations, 0.8 percent, and CD-TLR, 23.5 percent (n=1,406).

“Superficial femoral artery (SFA) disease is becoming more prevalent globally and is often difficult to treat due to its complex nature. Now more than ever, it is important to carefully assess how therapies to treat this condition perform over the long-term among real-world patients,” said Prof. Tepe. “IN.PACT Global was designed with this goal in mind and has now demonstrated the durability, efficacy, and safety of IN.PACT Admiral in complex lesions out to three years – something few SFA studies have been able to achieve thus far.”

The IN.PACT Global Study is the largest and most rigorous real-world evaluation of any peripheral artery intervention ever undertaken and intends to characterize the performance of the IN.PACT Admiral DCB in treating real-world patients with challenging and complex lesions. The study included adjudication of events by an independent clinical events committee.


For Further Information

More on the peripheral vascular stent market in the U.S. can be found in a report series published by iData Research entitled the U.S. Market Report Suite for Peripheral Vascular Devices and Accessories. The suite covers reports on the following markets: Peripheral Vascular Stent Market, PTA Balloon Catheter Market, Atherectomy Device Market, Chronic Total Occlusion (CTO) Device Market, Embolic Protection Device Market, Stent Graft Market, Surgical Graft Market, Diagnostic and Interventional Catheter Market, Diagnostic and Interventional Guidewire Market, Introducer Sheath Market, Inferior Vena Cava Filter Market, Arteriovenous (AV) Access Thrombectomy Device Market, Vascular Closure Device Market, and Transcatheter Embolization Device Market.

Reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about peripheral vascular device market data or procedure data, register online or email us at for a U.S. Market Report Suite for Peripheral Vascular Devices and Accessories brochure and synopsis.

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