Advancing innovative technology for better outcomes in Peripheral Artery Disease (PAD)

I’m delighted that we have completed the enrollment of the first patient in Abbott’s LIFE-BTK trial examining the utility of our investigational drug-eluting resorbable scaffold, Esprit™ BTK. This is an important development in our quest to reduce the burden of peripheral artery disease, and potentially, a significant step towards more widespread use of resorbable technology.

This news is particularly exciting owing to the paucity of current treatment options available for peripheral artery disease (PAD) below the knee. A great many patients suffer from PAD, and as these individuals reach the more advanced stages of the disease, when blocked vessels impair blood flow to the lower legs and feet, severe pain and risk of gangrene may result. The current standard of care for these patients is percutaneous transluminal angioplasty (PTA), namely balloon dilatation, to stretch open narrowed arteries - and this strategy alone does not provide sustained good outcomes. Unlike in coronary interventions, the use of metallic stents to capitalize upon the effects of ballooning is discouraged, principally to keep options open for future re-interventions; a drug-eluting resorbable scaffold could potentially fulfill this unmet need.

Innovative product design

At Abbott, we’re always working towards better, minimally-invasive ways to help treat vascular disease, and, with Esprit™ BTK, we’re building on our experience from previous iterations of resorbable technology. The thin-strut scaffold is made from the resorbable polymer poly-L-lactide (PLLA), engineered for radial strength, and coated with poly-D,L-Lactide (PDLLA), allowing controlled drug release of the antiproliferative drug everolimus.

The technology works initially in exactly the same way as a traditional metallic stent by first ensuring that the vessel doesn’t simply recoil or collapse once the angioplasty balloon is withdrawn; the controlled release of everolimus then ensures that inflammation and scar tissue doesn’t form in the affected area, causing recurrent narrowing or restenosis.

The scaffold is subsequently reabsorbed into the tissues (like a dissolving suture) over a period of up to 36 months, leaving a healed artery in its natural state that can flex and pulse. The advantage here is that once the scaffold has disappeared, there’s nothing that will compromise further endovascular procedures or surgery. The same cannot be said for metal stents, which, when left in place, make repeat interventions tricky, surgery impossible and can compromise non-invasive imaging techniques.

I firmly believe that resorbable technology is ideally suited for below-the-knee (BTK) arterial disease treatment, and that we could be on the verge of meaningful improvements in treatment for PAD and its related complications. It’s an exciting time to be a part of the team that is bringing this technology to fruition; I’m looking forward to seeing the results of this trial and the potential of this technology to change the lives of patients who live with PAD.