US-based Elixir Medical has obtained CE Mark approval for its fully-bioresorbable DESolve 100 Novolimus eluting coronary scaffold system.
Elixir Medical claims that its user-friendly DESolve 100 is the world’s first scaffold with a thinner strut profile of 100µm designed to degrade within one year, returning the patients’ coronary vessel ultimately to its normal de novo state.
With DESolve 100, cardiologists can address the needs of a broader patient population. In addition, the improved inter-strut flow dynamics of the DESolve 100 are designed for excellent clinical outcomes.
DESolve 100 will be offered in sizes ranging from 2.5-3.5mm. Elixir Medical plans to commercially launch the device in 2015.
DESolve 100 is developed from the same proprietary poly-L Lactide (PLLA)-based material that has been used to develop the company’s CE marked DESolve scaffold. The PLLA-based material provides optimal strength and support to the artery while delivering the novel anti-proliferative drug, Novolimus.
The DESolve family of scaffolds has the ability to self-appose to the nominal vessel wall size in cases of mal-apposition and they have the ability to have a wide margin of expansion.
Additionally, they have the ability to maintain radial strength and vessel support for the necessary period of vessel healing while degrading within a year.
In the DESolve Nx pivotal trial, which evaluated the DESolve scaffold system, 126 patients were enrolled at 13 centers in Europe, Brazil and New Zealand.
In addition to quantitative coronary angiography follow-up on all patients, a subset of 46 patients underwent intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging at baseline and six-month follow-up, demonstrating excellent 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 added.
Elixir Medical has announced a post-approval clinical study of 100 patients with sites in Brazil and Europe to support the international commercialization 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.