Dive Brief:
- A post-approval trial of Medtronic’s drug-coated balloon in end-stage kidney disease patients has replicated the results of a pivotal study.
- The data, which Medtronic reported Wednesday, showed 70.2% of lesions stayed open without reintervention or causing thrombosis 12 months after treatment. Medtronic reported a 65.3% rate in its pivotal randomized trial of the IN.PACT AV DCB device.
- While the pivotal trial supported approval, the FDA required Medtronic to run the post-approval study to evaluate long-term safety amid concerns about the risks of paclitaxel-coated devices.
Dive Insight:
The FDA approved IN.PACT AV DCB in 2019. At that time, regulators and researchers were still trying to understand a meta-analysis that linked paclitaxel balloons and stents to an increased risk of death in peripheral artery disease patients. The risks to kidney disease patients with arteriovenous fistula, an irregular connection between an artery and a vein, were unknown.
While there was no trend toward increased mortality after one year of Medtronic’s pivotal trial, the FDA asked the company to monitor device safety for up to five years in two post-approval studies. One study built on an existing trial, and the other enrolled new patients.
Medtronic shared data from the new enrollment trial at the Society of Interventional Radiology’s annual meeting. The analysis looked at target lesion primary patency, defined as freedom from clinically driven target lesion revascularization or access circuit thrombosis post-index procedure, in patients who met the criteria for participating in the pre-approval trial.
On that endpoint, IN.PACT AV DCB performed as well in the post-approval study as it did in the pivotal trial. The DCB patency rates were better than for standard percutaneous transluminal angioplasty, a minimally invasive procedure to open a blocked artery, which achieved a 46.3% result after 12 months.
Medtronic said fewer than one reintervention per patient was required through 12 months, compared to an average of 1.5 in a separate claims data study. The serious infection rate at 12 months was 13.4%, which Medtronic also compared favorably to historical controls. Medtronic shared more safety data in its submission to the FDA.
Concerns about the death rate in recipients of paclitaxel devices have receded since the FDA approved IN.PACT AV DCB. The agency withdrew its warning about the devices in 2023 after an analysis showed they are unlikely to increase the risk of death.
