Successful Live Case Follow-up of DESolve Nx Trial patient at 18
months at TCT 2013
SUNNYVALE, Calif.--(BUSINESS WIRE)--
Elixir Medical Corporation, a developer of products that combine
state-of-the-art medical devices with advanced pharmaceuticals,
announced excellent one-year results from the DESolve Nx international
pivotal clinical trial for the CE Mark-approved, fully bioresorbable
DESolve® Novolimus Eluting Coronary Scaffold System.
At one year, the DESolve Nx trial demonstrated a low MACE (Major Adverse
Cardiac Events) rate of 5.69% with no definite scaffold thrombosis. The
results were presented by Stefan Verheye, M.D., Ph.D., ZNA Middleheim
Hospital, Antwerp, Belgium, and Co-Principal Investigator of the DESolve
Nx Trial at the 25th annual Transcatheter Cardiovascular Therapeutics
(TCT) Conference in San Francisco. The trial represents one of the
largest multi-modality imaging studies in the industry for bioresorbable
scaffolds with angiographic, IVUS, OCT, and MSCT follow ups.
Results using MSCT (Multi Slice Coherence Tomography), a noninvasive
imaging modality to visualize coronary arteries and the manifestations
of coronary artery disease, demonstrated a mean lumen area of 5.5 ± 2.2
mm2 at one year, maintaining the results that were observed
at 6 months using other imaging modalities.
“The 12-month results of the DESolve scaffold demonstrated sustained
clinical outcomes at one year, further validating the scaffold as an
excellent treatment option for coronary artery disease,” said Dr.
Verheye. DESolve Nx pivotal trial enrolled 126 patients at 13 centers in
Europe, Brazil and New Zealand. In addition to Quantitative Coronary
Angiography (QCA) follow-up on all patients, a subset of 46 patients
underwent Intravascular Ultrasound (IVUS) and Optical Coherence
Tomography (OCT) imaging at baseline and 6-month follow-up.
At 6 months, Elixir’s DESolve demonstrated excellent mean late lumen
loss of 0.21±0.34 mm as measured by QCA. IVUS imaging results
demonstrated a statistically significant increase of 9% in the lumen
area between post procedure and 6-month follow-up with no late acquired
ISA (incomplete scaffold apposition). OCT imaging results demonstrated
an impressive 99% strut coverage with a thin and uniform 0.10 mm
neointimal layer and confirmed no late acquired ISA.
Successful Live Case follow-up of DESolve Nx patient at 18 months
Professor Alexandre Abizaid, M.D., Ph.D., of The Instituto Dante
Pazzanese de Cardiologia, Brazil, conducted a successful live case from
Sao Paulo of a patient enrolled in the DESolve Nx trial undergoing
18-month follow-up. The angiographic, IVUS, OCT, and MSCT imaging of the
coronary vessels treated with the DESolve Scaffold was projected live in
the main arena at the 25th TCT conference. The coronary vessels of the
patient were widely patent with substantial scaffold resorption when
viewed using the IVUS and OCT imaging modalities. These excellent
results were well-received by an expert panel of cardiologists gathered
in San Francisco.