Manufacturer of drug-eluting stent systems Elixir Medical has gained CE Mark approval for its fully bioresorbable DESolve 100 Novolimus eluting coronary scaffold system.
Featuring a thinner strut profile of 100µm, the scaffold has been designed to degrade in one year. The improved inter-strut flow dynamics of the DESolve 100 are designed for excellent clinical outcomes.
Elixir Medical's DESolve 100 will be available in sizes ranging from 2.5mm-3.5mm. The company plans to commercially launch the device in 2015.
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.
Elixir Medical used the same PLLA-based polymer in its previous DESolve scaffold. The DESolve family of scaffolds has the ability to self-appose to the nominal vessel wall size in cases of mal-apposition and they can have a wide margin of expansion.
In addition, these scaffolds can maintain radial strength and vessel support for the necessary period of vessel healing while degrading within a year.
The DESolve scaffold system was evaluated in the DESolve Nx pivotal trial, which enrolled 126 patients at 13 centres in Europe, Brazil and New Zealand.
In addition to quantitative coronary angiography follow-up on all patients, a subset of 46 patients had intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging at baseline and six-month follow-up, demonstrating high-level results.
Subsequently, at one year, the DESolve Nx trial demonstrated a low major adverse cardiac events rate of 5.69% with no definite scaffold thrombosis.
Elixir Medical CEO Motasim Sirhan said that the company'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.
"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," Sirhan said.
Elixir Medical has announced a post-approval clinical study of 100 patients with sites in Brazil and Europe to support the international commercialisation and reimbursement of DESolve 100.
In addition to QCA follow-up on all patients, a subset of patients will undergo IVUS and OCT imaging at baseline and six-month follow-up. All patients will be followed up at one year with annual clinical follow-ups through five years.