Medtronic Announces FDA Approval for IN.PACT 018 PTA Balloon Catheter

May 27, 2022 — Medtronic today announced U.S. Food and Drug Administration (FDA) approval for the IN.PACT paclitaxel-coated balloon catheter IN.PACT, a drug-coated balloon (DCB), indicated for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries.

In the United States alone, 12 million people have PAD,1 a buildup of plaque in the walls of the arteries, which restricts or stops the flow of oxygen-rich blood to the limbs – and half of these people go untreated, increasing the risk of amputation.2

“The IN.PACT 018 DCB will allow physicians to better treat difficult cases, such as those with narrow lesions or complex tomies,” said Prakash Krishnan, MD, FACC, associate professor of medicine, cardiology and radiology at the Icahn School of Medicine. at Mount Sinai, who also sits on Medtronic’s Scientific Advisory Board. “The long-term data available [from the IN.PACT Admiral studies] on its benefits offers physicians another effective treatment for PAD in complex autonomies. »

The IN.PACT 018 DCB uses the same drug coating formulation and is built on equivalent technology to the IN.PACT™ Admiral™ DCB, which is compatible with 0.035″ guidewires. The IN.PACT 018 DCB is indicated for the ATP of de novo, restenotic or in-stent restenotic lesions with lengths up to 360mm with vessel diameters of 4-7mm.It is designed to cross narrow lesions, offers better deliverability§ and is compatible with 0.018″ guide wires.

The IN.PACT 018 DCB will be the only commercially available DCB with an over-the-wire (OTW) catheter length of 200cm, giving physicians the option to treat via femoral or radial access. This is in addition to the OTW catheter length of 130cm.

“Medtronic is committed to providing physicians with a suite of products to treat patients with PAD. Based on feedback from our clinical community and the need for a DCB compatible with the 018″ guidewire, Medtronic is excited to bring this technology to market in the United States,” said David Moeller, business unit president of Peripheral Vascular Health at Medtronic “The addition of the IN.PACT 018 DCB further reinforces Medtronic’s commitment to being the market leader in drug-coated balloons.”

With more than 3,500 patients enrolled in 21 clinical studies and more than 500,000 patients treated worldwide†, the IN.PACT Admiral DCB has strong clinical results, including: best patency benefit over 3 years,3‡ having the lowest clinically motivated target lesion revascularization (CD-TLR) over 5 years3, and most publications for DCB*. Considering the design similarities, the IN.PACT clinical program can be considered as support for the DCB IN.PACT 018.

The safety and efficacy of the IN.PACT Admiral DCB (compatible with the 0.035 inch guide wire), as established in clinical studies (performed mainly via femoral access), can be considered in favor of the IN.PACT 018 BCD. IN.PACT 018 DCB has not been evaluated in a clinical study.

In collaboration with leading clinicians, researchers and scientists around the world, Medtronic offers a wide range of innovative medical technologies for the interventional and surgical treatment of cardiovascular and peripheral vascular diseases. The company strives to provide products and services that deliver clinical and economic value to consumers and healthcare providers worldwide.

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1 Goodney PP, Tarulli M, Faerber AE, Schanzer A, Zwolak RM. Fifteen-year trends in lower extremity amputation, revascularization, and preventive measures among Medicare patients. JAMA Surg. 2015 Jan;150(1):84-86.|
2 Goodney PP, Travis LL, Nallamothu BK, et al. Variation in the use of lower limb vascular procedures for critical limb ischemia. Circ Cardiovascular Qual Results. 2012 Jan;5(1):94-102.
3 Laird JA, Schneider PA, Jaff MR, et al. Long-term clinical efficacy of a drug-coated balloon for the treatment of femoropopliteal lesions. 5-year results of the IN.PACT SFA trial. Circ Cardiovascular Interv. 2019 Jun;12(6):e007702.

‡ Primary patency not assessed after three years.

†Based on units sold divided by units per procedure since approval through September 2019.

* Publications archived by Medtronic.

§ Data on file with Medtronic.

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