FDA Granted Breakthrough Status to New Below-Knee Catheter
The device aims to treat severe leg artery disease and reduce amputation risks for patients.
Updated on Oct. 1, 2026 in Stroke
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The FDA has granted breakthrough device designation to a new catheter from Medtronic designed to treat arterial disease below the knee. This designation accelerates the development of the tool for patients at risk of major amputation due to chronic limb-threatening ischemia.
Why it matters
Currently, no drug-coated balloons are approved in the United States for treating lesions below the knee, where standard uncoated angioplasty remains the primary care method. This development aims to provide a new therapeutic option for individuals facing the risk of death or limb loss from advanced peripheral artery disease.
Previous trials of the company's related drug-coated balloon technology reported a 70.2% target lesion primary patency rate. Researchers are now initiating a randomized pivotal trial of approximately 400 participants to evaluate the device specifically for below-knee peripheral artery disease.
The players
Medtronic
A global medical technology company that develops cardiovascular devices including drug-coated balloons for arterial disease.
FDA
The United States federal agency responsible for protecting public health by regulating medical devices and ensuring the safety of clinical trials.
Abbott
A medical device manufacturer that produces vascular technologies, including the Esprit BTK drug-eluting scaffold.
The details
The catheter works by delivering paclitaxel directly to the vessel wall, which acts to inhibit the growth of scar tissue that often causes vessels to narrow again after treatment. This is designed to improve long-term vessel patency compared to standard uncoated percutaneous transluminal angioplasty, which is the current treatment standard for patients with chronic limb-threatening ischemia.
Timeline
2017: Medtronic launched a feasibility study for the In.Pact BTK catheter.
July 2026: The FDA approved Abbott's Esprit BTK drug-eluting scaffold.
October 1, 2026: Medtronic received breakthrough designation for the device.
Next few months: Medtronic expects to finalize the pivotal trial design.
Health Landscape
This development expands the options for treating below-the-knee peripheral artery disease, which has historically relied on uncoated angioplasty. It follows the July 2026 approval of Abbott's Esprit BTK scaffold, signaling a shift toward more advanced, drug-eluting interventions.
If you or a family member are living with peripheral artery disease, this technology may eventually offer a new way to manage the risk of limb loss. You should discuss with your physician whether clinical trial participation or upcoming therapies might be relevant to your long-term care plan.
The takeaway
The FDA breakthrough designation signals an accelerated path toward potentially new tools for managing severe arterial disease below the knee. Patients facing these risks should continue monitoring their symptoms and discuss all current treatment options with a vascular specialist.
What happens next
Medtronic plans to finalize the design for an international, randomized pivotal trial involving approximately 400 participants within the next few months.
Further reading
Learn more about advancements in vascular care and management in our Stroke section.
Source note: This article includes information reported by MassDevice.
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