In short
Californian Elixir Medical Corporation has chosen EuroPCR 2012 in Paris as the event at which to issue a press release announcing what it claims are outstanding six-month clinical and angiographic data for its 15-patient First-In-Man clinical study of the fully bioresorbable drug-eluting scaffold, the DESolve™ Bioresorbable Coronary Scaffold System. The data was presented at a late-breaking trial session of the EuroPCR course.
Background
It’s a big ask for a bioresorbable scaffold to replace a metallic stent, because of the level of strength and support demanded combined with the need to demonstrate safe and gradual bioresorption of the strong scaffold once the blood vessel has healed and can support itself. Then there’s the inclusion of an active pharmaceutical ingredient and demonstration of its therapeutic, anti-proliferative effect.
The DESolve scaffold made from a proprietary and proven poly-L Lactide (PLLA)-based polymer is claimed to provide optimal strength and support to the artery while delivering an anti-proliferative drug, and is designed to resorb in the body within 1-2 years.
Study findings
At 6 months, Elixir’s DESolve demonstrated:
- excellent 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 MACE event 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. Optical Coherence Tomography, which provides high resolution intravascular imaging, confirmed what the release calls these outstanding results and showed that over 98% of the scaffold struts were covered with a thin, uniform neointimal layer (0.12 mm) at six 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.
Clinician comments
“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,” said Stefan Verheye, MD., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium, and Principal Investigator of the DESolve I Study, who presented the results at a Hot Line session. “Having used the DESolve bioresorbable scaffold system and observed its impressive performance and follow up results, I am confident that Elixir’s DESolve scaffold system has the potential to reduce long-term adverse clinical events, and eliminate the need for long-term dual anti-platelet therapy.”
Company comments
“Elixir Medical is excited about the potential impact of this revolutionary technology on vascular intervention, and is committed to bringing DESolve to the market through evidence-based clinical research,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical. “In order to provide our physicians with unrivaled treatment options to improve patient outcomes, Elixir has ensured that DESolve will be available in a broad range of sizes, and that our manufacturing capacity is scalable for future studies and commercialization.”
Further study
To build upon the excellent results of the DESolve FIM study, Elixir has initiated a pivotal trial, the DESolve Nx, which is currently enrolling 120 patients across Europe, New Zealand and Brazil. This trial will evaluate the safety and efficacy of Elixir’s DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System with the primary safety endpoint being a composite of major adverse cardiac events (MACE). The primary angiographic endpoint of the trial will be in-stent late lumen loss at 6 months for all patients as assessed by QCA (Quantitative Coronary Angiography).
Source: Elixir Medical Corporation, Business Wire
published: May 17, 2012 in: Cardio, Clinical Studies/Trials, Congresses and Meetings, Technology