Medtronic’s IN. PACT BTK Receives FDA Breakthrough Device Designation

Medtronic has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its investigational IN.PACT BTK Paclitaxel Drug-Coated Balloon Catheter, being developed to treat peripheral arterial disease (PAD) below the knee.

Below-the-knee PAD is associated with a high risk of limb loss and death, particularly in patients with chronic limb-threatening ischaemia (CLTI). 

The condition commonly affects people with underlying conditions such as diabetes and chronic kidney disease.

Drug-coated balloons are established for treating PAD in arteries above the knee, but there is currently no commercially available drug-coated balloon indicated for below-the-knee PAD in the US.
 
As a result, uncoated balloon angioplasty remains a key endovascular treatment option, despite the risk of restenosis and repeat procedures.

Medtronic is planning the global IN.PACT BTK DELTA pivotal study to evaluate the safety and effectiveness of the investigational device. 

The randomised trial is expected to enrol around 400 patients with below-the-knee lesions. The company is working with regulators and investigators to finalise the study design.

The IN.PACT BTK device uses Medtronic’s existing IN.PACT platform and FreePac paclitaxel coating technology. 
The Breakthrough Device designation is intended to support faster interaction with the FDA during development and regulatory review.

The programme aims to generate clinical evidence for a potential treatment option for patients with advanced PAD and CLTI affecting below-the-knee arteries.

Source: https://news.medtronic.com