Elixir Medical Corporation, a developer of product platforms that combine state-of-the-art medical devices with advanced pharmaceuticals, announced that it has received CE (Conformité Européenne) Mark approval for its DESolve 100 Novolimus Eluting Bioresorbable Coronary Scaffold System. The world’s first scaffold with a dramatically thinner strut profile of 100µm (one hundred microns) is designed to degrade within one year, returning the patients’ coronary vessel ultimately to its normal de novo state while providing market-leading deliverability and conformability. DESolve 100 is designed to make scaffolds more user-friendly, enabling cardiologists to address the needs of a broader patient population. Furthermore, the improved inter-strut flow dynamics of the DESolve 100 are designed for excellent clinical outcomes.
Like the CE Marked and clinically-proven DESolve scaffold, DESolve 100 is developed from the same proprietary poly-L Lactide (PLLA)-based material that provides optimal strength and support to the artery while delivering the novel anti-proliferative drug, Novolimus. The unique attributes of the DESolve family of scaffolds include (a) the ability to self-appose to the nominal vessel wall size in cases of mal-apposition; (b) the ability to maintain radial strength and vessel support for the necessary period of vessel healing while degrading within a year; and (c) the ability to have a wide margin of expansion.
“Elixir’s DESolve scaffold is already transforming the treatment of patients with coronary artery disease by providing the optimal vessel support while degrading in about a year leaving the vessel free of a permanent metallic implant,” said Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium, who treated the first patient with DESolve 100. “The CE Mark approval for the breakthrough DESolve 100 scaffold builds on the clinically-proven success of DESolve.”
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 mm 2 at one year, maintaining the results that were observed at 6 months using other imaging modalities.
“Elixir’s DESolve scaffold achieved the goal of the interventional cardiologist to treat and return the patient’s arteries to their de novo state in one year,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical. “With the CE Mark approval of DESolve 100, Elixir fulfills its commitment of developing the world’s first fully bioresorbable scaffold that matches the thin strut profile, excellent deliverability, and enhanced conformability of market-leading coronary drug eluting stents to ensure its greater adoption in everyday clinical practice.”
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.