Medtronic launches new study of below-the-knee peripheral arterial disease

Medtronic has announced the launch of a European study that will assess the benefits of a new treatment approach for below-the-knee peripheral arterial disease.

The IN.PACT BTK study is intended to evaluate the effectiveness of using a drug-coated balloon in patients with this form of the disease, specifically focusing on the IN.PACT 0.014 paclitaxel-coated percutaneous transluminal angioplasty balloon catheter.

This investigational device uses Medtronic's unique IN.PACT Admiral drug coating technology, and has already shown promise in the treatment of superficial femoral arteries.

IN.PACT BTK will enrol approximately 60 patients at four sites in Europe, with the primary endpoint being late lumen loss levels at nine months – an important angiographic measure of drug effectiveness.

The first procedure to be carried out as part of the trial was performed on a patient with critical limb ischaemia at Maria Cecilia Hospital in Italy, with the individual said to be doing well post-treatment.

Mark Pacyna, vice-president and general manager of Medtronic's peripheral business, said: "Peripheral artery disease below the knee is complex. With these prior analyses, we have developed an unmatched knowledge around the treatment of below-the-knee disease and critical limb ischaemia."

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