Medtronic has received US Food and Drug Administration (FDA) Breakthrough Device designation for its IN.PACT below-the-knee (BTK) drug-coated balloon.
While drug-coated balloons transformed treatment above the knee, physicians treating chronic limb-threatening ischemia (CLTI) below the knee are still working with a standard of care that often falls short, describes the company in a recent press release.
Currently, Medtronic is planning IN.PACT BTK DELTA, a global, randomised pivotal trial enrolling approximately 400 patients with BTK lesions. According to the company, this is a notable trial in regards to scale for the investigation of BTK peripheral arterial disease (PAD), designed to generate the kind of evidence-based data this field has been missing.
The company is set to present the technology at the upcoming 2026 Vascular InterVentional Advances (VIVA; 4–7 October, Las Vegas, USA) conference. On October 6, Eric A Secemsky, principal investigator and interventional cardiologist at Beth Israel Deaconess Medical Center in Boston, USA, will present on the IN.PACT BTK drug-coated balloon during ‘Red Horizons: The VIVA Innovation Summit’.
