CE Mark Approved for Elixir Medical's Bioresorbable DESolve 100 Coronary Scaffold

May 13, 2014—Elixir Medical Corporation announced that it has received European CE Mark approval for its DESolve 100 novolimus-eluting, bioresorbable coronary scaffold system. The DESolve 100 will be available in sizes ranging from 2.5 mm to 3.5 mm, with a commercial launch planned for 2015.

The company advised that to support the international commercialization of and reimbursement for DESolve 100, Elixir has announced a postapproval clinical study of 100 patients with sites in Brazil and Europe. In addition to quantitative coronary angiography follow-up on all patients, a subset of patients will undergo intravascular ultrasound and optical coherence tomography imaging at baseline and 6-month follow-up. All patients will receive follow-up at 1 year, with annual clinical follow-up through 5 years.

According to Elixir Medical, the DESolve 100 device is designed to degrade within 1 year of implantation, returning the patient's coronary vessel to its normal de novo state. It has a thin strut profile of 100 µm and provides excellent deliverability and conformability. DESolve 100 is designed to make scaffolds more user-friendly and enable interventionists to address the needs of a broader patient population. The improved interstrut flow dynamics of the DESolve 100 are designed for excellent clinical outcomes.

Elixir Medical stated that the DESolve 100 was developed from the same poly-L lactide–based material as the company’s CE Mark-approved DESolve scaffold. The material provides optimal strength and support to the artery while delivering the novel antiproliferative novolimus drug. The DESolve family of scaffolds can self-appose to the nominal vessel wall size in cases of malapposition and maintain radial strength and vessel support for the necessary period of vessel healing while degrading within a year; they also have a wide margin of expansion.

The company reported that the DESolve scaffold system was evaluated in a pivotal trial that enrolled a total of 126 patients at 13 centers in Europe, Brazil, and New Zealand. All patients received quantitative coronary angiography follow-up. Additionally, a subset of 46 patients underwent intravascular ultrasound and optical coherence tomography imaging at baseline and 6-month follow-up, demonstrating excellent results. Subsequently, at 1 year, the DESolve Nx trial demonstrated a low rate of major adverse cardiac events (5.69%) with no definite scaffold thrombosis. Moreover, results using multislice coherence tomography demonstrated a mean lumen area of 5.5 ± 2.2 mm² at 1 year, maintaining the results that were observed at 6 months using other imaging modalities.

Stefan Verheye, MD, of ZNA Middleheim Hospital in Antwerp, Belgium, treated the first patient with the DESolve 100. Dr. Verheye commented in the company’s press release, “Elixir’s DESolve scaffold is already transforming the treatment of patients with coronary artery disease by providing the optimal vessel support while degrading in about a year, leaving the vessel free of a permanent metallic implant. The CE Mark approval for the breakthrough DESolve 100 scaffold builds on the clinically-proven success of DESolve.”