Esprit BTK was approved by the FDA in April. Image credit: Shutterstock / Sundry Photography.

Abbott has unveiled positive long-term data for its Esprit below-the-knee (BTK) stent in treating the most severe form of peripheral artery disease (PAD).

The data, which was presented as a late-breaking clinical trial at the Vascular InterVentional Advances (VIVA) 2024 meeting, demonstrated that Abbott’s device offered sustained benefits over balloon angioplasty.

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The LIFE-BTK trial evaluated Esprit BTK in 260 people worldwide with PAD below the knee. Abbott’s stent is an everolimus-eluting resorbable scaffold system that treats lesions via vessel recoil and dissection. It comprises material similar to dissolving sutures that helps heal the vessel once the blockage is opened and provides support through an immunosuppressant drug until the vessel is strong enough to remain open on its own.

Esprit BTK, which was approved by the US Food and Drug Administration (FDA) in April, showcased two-year strong results in patients undergoing treatment. Around 90% of patients with the stent did not require a reintervention at 24 months and compared to standard treatment balloon angioplasty, had more freedom from chronic limb-threatening ischemia, a severe form of PAD.

PAD affects eight to 12 million people in the US, with that number forecast to rise over the next decade. In severe cases of PAD, blocked vessels reduce blood flow to the lower extremities, which could lead to amputations if treatment is unsuccessful.

A market model by GlobalData forecasts the peripheral vascular stent market to be worth $3bn by 2033.

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Abbott’s vascular business divisional vice president of global clinical affairs Jennifer Jones-McMeans said: “The positive results at two years reinforce Esprit BTK’s potential to revolutionise the treatment of peripheral artery disease below the knee. By eliminating the need for multiple interventions and in some cases, amputation, we’re ultimately helping people live fuller, better lives.”

Abbott said it has also launched a post-market approval study to assess the stent’s safety and effectiveness in treating chronic limb-threatening ischaemia – the first patient has already been enrolled in the US.

Johnson & Johnson’s (J&J) Shockwave Medical revealed positive results from a trial investigating its peripheral intravascular lithotripsy (IVL) catheter technology today. The system, called Javelin, also treats patients with PAD. Philips, meanwhile, enrolled the first patient in a PAD trial evaluating its combined laser atherectomy and intravascular lithotripsy catheter.