Abbott (NYSE:ABT) launched a European clinical trial for its Esprit drug-eluting bioresorbable vascular scaffold to treat leg pain associated with peripheral artery disease.
The Esprit drug eluting BVS is designed to treat blockages in the superficial femoral arteries and iliac arteries that cause leg pain in patients while walking.
"Current endovascular therapies, such as self-expanding stents and angioplasty balloons, have limitations and have not solved the problem of restenosis," principal investigator Dr. Johannes Lammer said in prepared remarks. "A bioresorbable drug-eluting device, designed to act as a temporary scaffold to support the vessel and then fully dissolve, may change the way we treat peripheral artery disease."
About 30 patients will test Abbott’s Esprit system in a single-arm multi-center European trial. Up to 10 clinical sites will participate in the trial.
Researchers will perform blood movement, functionality and quality-of-life follow-ups with patients after 1 month, 6 months, 12 months, and 2 and 3 years after the procedure.
"In addition to Esprit I, we also are investigating our bioresorbable therapy for the treatment of below-the-knee critical limb ischemia – a severe form of PAD – in the Absorb BTK trial," Abbott Vascular’s Dr. Charles Simonton said in prepared remarks. "We’ve seen promising long-term clinical data with our bioresorbable therapy in coronary patients, and we believe there is potential for this technology in the treatment of PAD."
The Chicago-area health care giant recently decided to spin out its research pharmaceuticals operation into an as-yet-unnamed publicly traded firm, keeping the Abbott brand for its diversified medical businesses.
It’s a sea change for 123-year-old Abbott, long noted for its diversification, chairman and CEO Miles White said.
Abbott said the move should be done by the end of 2012. Its board must still approve the split, which will not affect its guidance for this year.