Elixir Medical concludes first-in-man study for coronary scaffold system

Medical device developer Elixir Medical (Sunnyvale, CA) presented intravascular ultrasound (IVUS), optical coherence tomography (OCT), and angiographic data from its 15-patient, first-in-man clinical trial of its DESolve bioresorbable coronary scaffold system. The system is made from the company's poly-L Lactide (PLLA)-based polymer to provide strength and support to the artery while delivering an anti-proliferative drug, and is designed to resorb in the body within 1–2 years.

At six months, the system demonstrated late lumen loss of 0.19 ± 0.19 mm, no reblockage of the artery (0.0% binary restenosis), no late malapposition (0.0%), low acute recoil (6.4% ± 4.3), no cases of blood clots (0.0% stent thrombosis), and a single major adverse cardiac event (MACE) due to a stenosis in the segment 5 mm proximal to the scaffold, which itself was widely patent. Imaging results also demonstrated low neointimal volume obstruction of 7.1% and no late recoil or scaffold shrinkage. OCT, which provides high-resolution intravascular imaging, confirmed the results and showed that over 98% of the scaffold struts were covered with a thin, uniform neointimal layer (0.12 mm) at 6 months. The 15 patients were enrolled in Europe and New Zealand, and will continue to be followed up at subsequent yearly intervals for 5 years.

"Bioresorbable scaffolds that restore the coronary vessel to its normal form and function without leaving a permanent implant in the body have long been considered the ultimate frontier in interventional cardiology," says Stefan Verheye, MD., Ph.D., ZNA Middleheim Hospital (Antwerp, Belgium), and principal investigator of the DESolve I Study, who presented the results. The system could also eliminate the need for long-term dual anti-platelet therapy, he notes.

The company has initiated a pivotal trial, DESolve Nx, which is currently enrolling 120 patients across Europe, New Zealand, and Brazil, and will evaluate the safety and efficacy of the system. The primary angiographic endpoint of the trial will be in-stent late lumen loss at 6 months for all patients as assessed by quantitative coronary angiography (QCA).


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