- Medtronic announced over the weekend favorable initial trial results for its investigational drug-coated balloon that aims to reduce the frequency of needed restenotic arteriovenous (AV) fistula maintenance procedures in patients with de novo or non-stented lesions.
- The creation of AV access sites is used to treat end-stage renal disease patients with hemodialysis, but vessel narrowing over time limits the ability to receive dialysis. Patients typically undergo one to three maintenance procedures per year, according to Medtronic.
- The 330 patient IN.PACT AV Access randomized controlled study, which examined freedom from clinically driven target lesion revascularization or access circuit thrombosis for six months, found the likelihood the vessel would remain open was 86.1% in the IN.PACT AV DCB group after 180 days compared to 68.9% in the percutaneous transluminal angioplasty control group.
Paclitaxel-coated balloons have come under fire this year after an FDA patient-level meta-analysis found a late mortality safety signal associated with the devices intended to treat femoropopliteal disease. In August, the agency announced it would work with manufacturers to update labeling for paclitaxel-coated devices to include information about the late mortality signal in peripheral artery disease patients.
Medtronic, which presented data at the FDA's June advisory panel on the topic, said the newly reported data adds to the body of evidence on safety for the devices.
The IN.PACT Admiral DCB received an expanded CE mark indication in Europe in January 2016 to treat AV access for patients with end-stage renal disease undergoing dialysis, but the IN.PACT AV DCB remains an investigational device in the United States.
In the study released Saturday, which examined patients undergoing dialysis for an average of 4.3 years, Medtronic found freedom from all-cause death after one year was 90.6% in the DCB group and 90.4% in the control group. Patients treated with the DCB underwent 56% fewer re-interventions after 210 days compared to those in the control group, according to the new data presented Saturday at the Cardiovascular and Interventional Radiology Society of Europe meeting in Barcelona.
Mark Pacyna, vice president of Medtronic’s peripheral vascular business in a statement said the data showed the potential for the device in treating high-risk patients, adding: "We look forward to generating further clinical evidence in support of this therapy."