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Breakthrough

Medtronic takes a Breakthrough designation into below-the-knee drug-coated balloons

MedDevice Startups Staff · 23 hrs ago · 2 min read · Via MedTech Dive

FDA granted Breakthrough Device designation on October 1 to IN.PACT BTK, a paclitaxel-coated balloon catheter Medtronic wants to use below the knee. No drug-coated balloon is approved for that territory in the US.

The randomized trial, IN.PACT BTK DELTA, will enroll roughly 400 patients with below-the-knee lesions. Eric Secemsky of Beth Israel Deaconess Medical Center is principal investigator. Medtronic says it is still finalizing the study design with regulators.

Above the knee the category is already crowded, with balloons from Boston Scientific, BD and Philips, plus Medtronic's own IN.PACT Admiral, approved in 2015. Below the knee the vessels are smaller and the restenosis problem is worse.

Designation does not move the evidence bar. It changes who picks up the phone at CDRH while a 400-patient randomized trial is being designed.

Questions & Answers

What is Medtronic's IN.PACT BTK?

IN.PACT BTK is a paclitaxel drug-coated balloon catheter from Medtronic intended to treat peripheral artery disease below the knee. FDA granted it Breakthrough Device designation on October 1, 2026.

Are any drug-coated balloons approved below the knee in the US?

No. As of Medtronic's October 1, 2026 Breakthrough designation for IN.PACT BTK, no drug-coated balloon is approved for use below the knee in the United States. The approved devices from Boston Scientific, BD, Philips and Medtronic treat disease above the knee.

What trial will test Medtronic's IN.PACT BTK?

Medtronic plans IN.PACT BTK DELTA, a randomized trial of roughly 400 patients with below-the-knee lesions, with Eric Secemsky of Beth Israel Deaconess Medical Center as principal investigator.

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