Dive Brief:
- Medtronic said Wednesday it received a breakthrough device designation from the Food and Drug Administration for a drug-coated balloon catheter to treat peripheral artery disease below the knee.
- While drug-coated balloons are commonly used to treat PAD above the knee, none are indicated in the U.S. for use below the knee, where improved treatment options are needed, Medtronic said. PAD causes reduced blood flow to the limbs due to plaque buildup in the arteries. Patients with advanced PAD can be at risk for amputation.
- Medtronic said it is planning a randomized pivotal trial to study the paclitaxel-coated device, called IN.PACT BTK, in about 400 patients with below-the-knee lesions.
Dive Insight:
Medtronic’s IN.PACT Admiral paclitaxel-coated balloon obtained FDA approval in 2015 for treating PAD in the upper leg. Other medical device makers with drug-coated balloons approved to treat PAD in arteries above the knee include Boston Scientific, BD and Philips.
In the smaller arteries below the knee, PAD has proven harder to treat. Plain balloon catheters are used to open the blocked arteries, but the vessels can become blocked again and require repeat procedures.
Dr. Eric Secemsky, an interventional cardiologist with Beth Israel Deaconess Medical Center, said finding effective treatments for patients with advanced PAD who have lesions below the knee “is one of the most pressing unmet clinical needs in contemporary endovascular therapy.”
Secemsky will be the principal investigator for Medtronic’s IN.PACT BTK DELTA clinical trial.
Drug-coated balloons are designed to reduce restenosis, or renarrowing of vessels. Medtronic said its planned study reflects the company’s “confidence in the safety and effectiveness of paclitaxel drug-coated balloons.”
The FDA’s breakthrough designation is intended to help expedite the device’s path to market. Medtronic said it is working closely with regulators and investigators to finalize the study design in the coming months.
