Elixir Completes First Commercial Implant Of Fully Bioresorbable Stent
Patient in Germany receives fully bioresorbable scaffold designed to degrade in one year
January 22, 2014
January 22, 2014 — The first commercial implant of Elixir Medical’s CE Mark-approved DESolve Novolimus Eluting Coronary Scaffold was performed in Germany by Prof. Dr. med. Holger Nef, head of the Cardiac Catheterization Laboratory, University Hospital Giessen, Giessen, Germany.
Elixir’s fully bioresorbable DESolve scaffold for coronary artery disease restores blood flow to the heart like metallic stents and then dissolves, resulting in a functional artery free of a permanent implant. Developed from a poly-L Lactide (PLLA)-based polymer, DESolve attempts to provide strength and support to arteries while delivering the anti-proliferative drug, Novolimus. It intends to maintain radial strength and vessel support during healing while degrading in one year, increase lumen area within six months, self-appose to the vessel wall up to the nominal deployed diameter and provide a wide margin of expansion.
“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,” Nef said.
The DESolve Nx pivotal trial enrolled 126 patients at 13 centers in Europe, Brazil and New Zealand. 1-year safety and efficacy results for the DESolve Novolimus Eluting Coronary Scaffold System were announced at the October 2013 Transcatheter Therapeutics scientific conference in San Francisco. At that time, the DESolve Nx trial had demonstrated a low Major Adverse Cardiac Events (MACE) rate of 5.69 percent with no definite scaffold thrombosis.
The fully bioresorbable DESolve Novolimus Eluting Scaffold System 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.
For more information: www.elixirmedical.com