Elixir Medical has announced the first commercial implant of CE Mark-approved DESolve Novolimus Eluting Coronary Scaffold, designed to degrade in 12 months and returning the patients’ coronary vessel to its normal de novo state.
The procedure was successfully performed by Professor Dr Holger Nef, head of the cardiac catheterisation laboratory, University Hospital Giessen, Giessen, Germany.
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Developed from a proprietary and proven poly-L Lactide (PLLA)-based polymer, the DESolve scaffold provides optimal strength and support to the artery, while delivering the novel anti-proliferative drug, Novolimus.
The unique attributes of the DESolve scaffold system include: self-apposing to the vessel wall up to the nominal deployed diameter; increasing lumen area within six months; and providing a wide margin of expansion.
University Hospital Giessen director of cardiology Christian Hamm said: "I am confident that Elixir’s scaffold system will drive forward the field of vascular intervention."
The DESolve Nx pivotal trial enrolled 126 patients at 13 centres in Europe, Brazil and New Zealand. At one year, the DESolve Nx trial demonstrated a low MACE (major adverse cardiac events) rate of 5.69% with no definite scaffold thrombosis.
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By GlobalDataElixir Medical president and CEO Motasim Sirhan said: "The fully bioresorbable DESolve Scaffold System holds the promise of transforming the interventional cardiology industry by raising the bar in clinical outcomes and leaving no permanent implant behind."
Elixir’s DESolve degrades in a timely manner, achieves vascular restoration within six months and maintains excellent clinical outcomes.
The company will roll-out fully bioresorbable DESolve Novolimus Eluting Scaffold System at initial centres in Europe.
The scaffold is currently available in diameters of 3.0mm, 3.25mm and 3.5mm and lengths of 14mm, 18mm and 28mm. Additional sizes will be available in 2014.
