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

June 4, 2012
Medical device developer Elixir Medical 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.

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).

-----

Follow us on Twitter, 'like' us on Facebook, and join our group on LinkedIn

Follow sister publication Laser Focus World on your iPhone or Android

Subscribe now to BioOptics World magazine; it's free!

Sponsored Recommendations

Linear voice coil motors offer peak force of 2.20 N

Nov. 24, 2023
The LVCM-013-032-02M and LVCM-013-032-02 are 12.7 mm diameter linear voice coil motors.

Image sensor has use in home and professional security

Nov. 23, 2023
The OS08C10 image sensor features both staggered high dynamic range (HDR) and single exposure dual analog gain (DAG).

Image sensor has use in home and professional security

Nov. 23, 2023
The OS08C10 image sensor features both staggered high dynamic range (HDR) and single exposure dual analog gain (DAG).

Dirac-vortex topological lasers meet silicon

Nov. 23, 2023
The Dirac-vortex state, a mathematical analog of Majorana fermions (a.k.a. angel particles) within superconducting electronic systems, offers a larger free spectral range than...

Voice your opinion!

To join the conversation, and become an exclusive member of Laser Focus World, create an account today!