Elixir Medical has announced the first commercial implant of its CE mark-approved DESolve novolimus-eluting coronary scaffold, which is designed to degrade within one year, has taken place in Germany. The procedure was performed by Holger Nef, head of the Cardiac Catheterization Laboratory, University Hospital Giessen, Giessen, Germany.
According to a press release, Elixir’s fully bioresorbable DESolve scaffold for coronary artery disease restores blood flow to the heart like metallic stents, but then dissolves to leave behind a treated artery that can function and move more naturally because it is free of a permanent implant. Developed from a proprietary and proven poly-L Lactide (PLLA)-based polymer, the deivce provides optimal strength and support to the artery while delivering the novel anti-proliferative drug, novolimus.
The press release reports that advantages of the DESolve scaffold system include (a) maintaining radial strength and vessel support for the necessary period of vessel healing while degrading in one year; (b) increasing lumen area within six months; (c) self-apposing to the vessel wall up to the nominal deployed diameter; and (d) providing 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,” said Nef.
The DESolve Nx pivotal trial enrolled 126 patients at 13 centres in Europe, Brazil and New Zealand. The press release states that excellent one-year safety and efficacy results for the DESolve novolimus-eluting coronary scaffold system were announced at the Transcatheter Cardiovascular Therapeutics 2013 scientific conference in San Francisco in October 2013. At one year, the DESolve Nx trial demonstrated a low MACE (major adverse cardiac events) rate of 5.69% with no definite scaffold thrombosis.