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

Built on the market-leading IN.PACT Admiral DCB technology, the IN.PACT 018 DCB is engineered to cross tight lesions and designed for better deliverability

May 27, 2022 — Medtronic today announced approval from the U.S. Food and Drug Administration (FDA) for the IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, a drug coated balloon (DCB), indicated for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries.

In the U.S. alone, 12 million people have PAD,¹ a buildup of plaque in the walls of arteries, which limits or stops the flow of oxygen-rich blood to the limbs — and half of these individuals remain untreated, raising the risk of amputation.²

“The IN.PACT 018 DCB will allow physicians to better address challenging cases, such as those with narrow lesions or complex anatomies,” said Prakash Krishnan, MD, FACC, associate professor of medicine, cardiology, and radiology at the Icahn School of Medicine at Mount Sinai, who also serves on a scientific advisory board for Medtronic. “The available long-term data [from the IN.PACT Admiral studies] on its benefits gives physicians another effective treatment for PAD in complex anatomies.”

The IN.PACT 018 DCB uses the same drug coating formulation and is built upon equivalent technology to the IN.PACT™ Admiral™ DCB, which is compatible with 0.035” guidewires. The IN.PACT 018 DCB is indicated for PTA of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm with vessel diameters of 4-7 mm. It is engineered to cross tight lesions, provide better deliverability§ and is compatible with 0.018" guidewires.

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

“Medtronic is committed to offering physicians a suite of products to treat patients with PAD. Based on feedback from our clinical community and the need for an 018” guidewire compatible DCB, Medtronic is excited to bring this technology to market in the U.S,” said David Moeller, president of the Peripheral Vascular Health Operating Unit 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 500,000+ patients treated worldwide†, the IN.PACT Admiral DCB has strong clinical outcomes, including: highest patency benefit through 3 years,^3‡^† having the lowest clinically driven target lesion revascularization (CD-TLR) through 5 years3, and most publications for a DCB*. Given the design similarities, the IN.PACT Clinical Program can be considered supportive for the IN.PACT 018 DCB.

The safety and effectiveness of the IN.PACT Admiral DCB (0.035 inch guidewire compatible), as established in the clinical studies (performed primarily via femoral access) can be considered supportive for the IN.PACT 018 DCB. The IN.PACT 018 DCB has not been evaluated in a clinical study.

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

For more information: www.medtronic.com

References

1 Goodney PP, Tarulli M, Faerber AE, Schanzer A, Zwolak RM. Fifteen-year trends in lower limb amputation, revascularization, and preventive measures among Medicare patients. JAMA Surg. January 2015;150(1):84-86.|
2 Goodney PP, Travis LL, Nallamothu BK, et al. Variation in the use of lower extremity vascular procedures for critical limb ischemia. Circ Cardiovasc Qual Outcomes. January 2012;5(1):94-102.
3 Laird JA, Schneider PA, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. 5-year results from the IN.PACT SFA Trial. Circ Cardiovasc Interv. June 2019;12(6):e007702.

‡ Primary patency not assessed after three years.

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

* Publications on file with Medtronic.

§ Data on file with Medtronic.

^† Compared to PTA