Marking a milestone in the evolution of fully-bioresorbable drug-eluting
scaffolds for interventional cardiology, the first commercial implant of
Elixir Medical's CE Mark-approved DESolve Novolimus Eluting Coronary
Scaffold was performed in Germany by Professor Dr. med. Holger Nef, Head
of the Cardiac Catheterization Laboratory, University Hospital Giessen,
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, DESolve
provides optimal strength and support to the artery while delivering the
novel anti-proliferative drug, Novolimus.
The unique 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
Professor Nef. Professor Dr. med. Christian Hamm, Director of Cardiology
at University Hospital Giessen further commented, "I am confident that
Elixir's scaffold system will drive forward the field of vascular
Developing an optimal bioresorbable scaffold had long been a challenge
in the coronary vascular industry because it requires a level of
strength and support that previously only permanent metallic stents had
been able to provide while degrading in a tmely manner and maintaining
excellent clinical outcomes. The DESolve Novolimus Eluting Bioresorbable
Coronary Scaffold overcomes these challenges and achieves vascular
restoration within six months. Elixir's DESolve accomplishes this
objective years sooner than competitive scaffolds.
"Elixir's DESolve has excellent clinical trial data to support its use.
It is the first scaffold to degrade in one year, demonstrate lumen area
increase within six months, and maintain the lumen area beyond one
year," said Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital,
Antwerp, Belgium, and Co-Principal Investigator of the DESolve Nx Trial.
"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. Excellent 1-year safety and efficacy
results for the DESolve Novolimus Eluting Coronary Scaffold System had
been announced at the Transcatheter 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.
Results using MSCT (Multi Slice Coherence Tomography), a noninvasive
imaging modality to visualize coronary arteries and the manifestations
of coronary artery disease, demonstrated that the lumen area
measurements of treated vessels at one year were maintained to the
results that were observed at 6 months using other imaging modalities.
"Elixir is proud to fulfill its commitment of providing the broadest and
most innovative product portfolio for cardiologists to address their
patients' needs," said Motasim Sirhan, President and Chief Executive
Officer of Elixir Medical. "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."
The fully bioresorbable DESolve Novolimus Eluting Scaffold System roll
out will begin 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.
About Elixir Medical
Elixir Medical is the only company with three CE Mark-approved
drug-eluting systems spanning all market segments: the DESolve Novolimus
Eluting Bioresorbable Coronary Scaffold system, the DESyne® BD
Novolimus Eluting Coronary Stent System (with biodegradable polymer),
and the DESyne® Novolimus Eluting Coronary Stent System (with
durable polymer). The company has also received US Food and Drug
Administration's IDE (Investigational Device Exemption) approval
to commence the EXCELLA III Clinical Trial in the United States with
Elixir's durable polymer Novolimus Eluting Coronary Stent System.
Elixir Medical Corporation, a privately held company headquartered in
Sunnyvale, California, develops products that combine state-of-the-art
medical devices with advanced pharmaceuticals to provide innovative
treatment solutions to patients worldwide. The company's next-generation
drug-eluting stent systems and bioresorbable coronary scaffold are
designed to optimize localized drug delivery to provide safe and
effective treatments for cardiovascular patients. For more information,
[ Back To NFVZone's Homepage ]