Elixir Medical Launches DESolve Coronary Scaffold System in Europe

January 15, 2014—Elixir Medical (Sunnyvale, CA) announced the European launch of the company's CE Mark-approved DESolve novolimus-eluting coronary scaffold. The first commercial implantation was performed by Professor Holger Nef, MD, who is Head of the Cardiac Catheterization Laboratory at University Hospital Giessen in Giessen, Germany.

The company will begin to introduce the device at initial centers in Europe. The scaffold is currently available in diameters of 3.0, 3.25, and 3.5 mm and lengths of 14, 18, and 28 mm. Additional sizes will be available in 2014, advised Elixir Medical.

In the company's press release, Prof. Nef commented, “The fully bioresorbable DESolve system is easy to deliver. The acute performance of the scaffold demonstrated excellent stent apposition to the vessel wall and low recoil, and the patient is doing well.” Prof. Christian Hamm, MD, Director of Cardiology at University Hospital Giessen, further commented, “I am confident that Elixir's scaffold system will drive forward the field of vascular intervention.”

According to the company, the fully bioresorbable DESolve scaffold for coronary artery disease was developed from the company's poly-L-lactide–based polymer to provide strength and support to the artery while delivering the antiproliferative drug novolimus.

The company noted that the DESolve scaffold system maintains radial strength and vessel support for the necessary period of vessel healing while degrading in 1 year, self-apposes to the vessel wall up to the nominal deployed diameter, and provides a wide margin of expansion.

Stefan Verheye, MD, of Middleheim Hospital in Antwerp, Belgium, served as coprincipal investigator of the DESolve Nx trial. Dr. Verheye stated in the company's announcement, “Elixir's DESolve has excellent clinical trial data to support its use. It is the first scaffold to degrade in 1 year, demonstrate lumen area increase within 6 months, and maintain the lumen area beyond 1 year. These key differentiating features will create a paradigm shift in the treatment of patients with cardiovascular disease.”

The DESolve Nx pivotal trial enrolled 126 patients at 13 centers in Europe, Brazil, and New Zealand.

In October, 1-year safety and efficacy results for the DESolve novolimus-eluting coronary scaffold system were announced at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California.

At 1 year, the DESolve Nx trial demonstrated a major adverse cardiac events rate of 5.69%, with no definite scaffold thrombosis. Results using multislice coherence tomography demonstrated that the lumen area measurements of treated vessels at 1 year were maintained to the results that were observed at 6 months using other imaging modalities.

In May, Elixir Medical announced the US Food and Drug Administration's investigational device exemption approval to commence the EXCELLA III clinical trial in the United States with the company's durable-polymer Desyne novolimus-eluting coronary stent system.