Elixir's dissolving stent aces 12-month study as Abbott duel looms

Elixir Medical's DESolve posted promising results at 12 months.--Courtesy of Elixir Medical

Elixir Medical notched more promising results for its DESolve device, keeping vessels clear with low rates of adverse events, and those data should help it contend with global giant Abbott Laboratories ($ABT) in the market for bioresorbable stents.

In 12-month results from 126 patients around the world, DESolve maintained healthy vessel diameters in line with its 6-month performance and posted a 5.7% rate of major adverse events with no definite scaffold clotting. Elixir used four different imaging techniques to survey DESolve's effects, giving the company greater surety and making the trial one of the largest multi-modality studies in the industry, co-principal investigator Stefan Verheye said.

"The 12-month results of the DESolve scaffold demonstrated sustained clinical outcomes at one year, further validating the scaffold as an excellent treatment option for coronary artery disease," Verheye said in a statement.

The device picked up a CE mark in May, and the latest successful study is designed to help Elixir increase its market share and contend with Abbott's Absorb, a similar device that hit the global market in September 2012. But despite Abbott's head start and larger sales presence, Elixir believes DESolve stands alone as the only bioresorbable scaffold that can increase vessel diameters in just 6 months and maintain them through 18 while harmlessly degrading after a year.

Meanwhile, Elixir is working to expand its share of the traditional stent market. In May the FDA gave its blessing to a 2,051-patient trial of Elixir's DESyne drug-eluting stent, which the company will compare to Medtronic's ($MDT) Resolute with an eye on stateside approval.

- read the results

Editor's note: An earlier version of this story misstated the nature of Elixir Medical's DESyne trial. We regret the error.

Sponsored By Metabolon

Five Translational Insights Key to a Successful First-in-Human (FIH) Study – Metabolite-Based Biomarker Discovery and Validation

Translational success rates from pre-clinical animal studies to human clinical trials remain frustratingly low. Learn how metabolomics helps you bridge between the theoretical & practical, between the function & actual activity of your drug molecule to get you closer to the phenotype, sooner.