Elixir Medical (Sunnyvale, CA) received European CE Mark approval for its DESolve 100 Novolimus-eluting coronary scaffold system. The stent-like device has a narrow strut profile of only 100µm and dissolves within about a year while releasing Novolimus, 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 Novolimus.
More from the announcement 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 no definite scaffold thrombosis. Moreover, 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.
To support the international commercialization and reimbursement of DESolve 100, Elixir has announced 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.
Product page: DESolve Scaffold System…
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