Elixir Medical (Sunnyvale, CA)*received European CE Mark approval for its DESolve 100 **volimus-eluting Coronary Scaffold system. The stent-like device has a narrow*strut profile of only 100µm and dissolves within about a year while releasing **volimus, a drug with anti-proliferative and anti-inflammatory properties.
The device itself is made from poly-L Lactide (PLLA)-based material, which maintains its strength while dissolving and releasing **volimus.
More from the an**uncement about the study that led to the approval:
A total of 126 patients were enrolled at 13 centers in Europe, Brazil and New Zealand in the DESolve Nx pivotal trial which evaluated the DESolve Scaffold system. 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, demonstrating excellent results. Subsequently, at one year, the DESolve Nx trial demonstrated a low MACE (Major Adverse Cardiac Events) rate of 5.69% with ** definite Scaffold thrombosis. Moreover, results using MSCT (Multi Slice Coherence Tomography), a **ninvasive 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.
To support the international commercialization and reimbursement of DESolve 100, Elixir has an**unced a post-approval clinical study of 100 patients with sites in Brazil and Europe. In addition to QCA follow-up on all patients, a subset of patients will undergo IVUS and OCT imaging at baseline and 6-month follow-up. All patients will be followed up at 1 year with annual clinical follow-ups through 5 years. DESolve 100 will be available in sizes ranging from 2.5mm to 3.5mm. Commercial launch is planned for 2015.
05-16-2014, 07:41 PM
Elixir DESolve 100 **volimus Eluting Coronary Scaffold System Cleared in Europe
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