Biodegradable Polymer Coats New Drug Eluting Stent

The low profile stent is design with ultrathin struts (81 µm) for high flexibility and deliverability, and is covered with an ultrathin (less than 3 µm) polymer coating, without the need for an underlying primer layer. The biodegradable, polylactide-based polymer enables the sustained release of Novolimus to the coronary vessel wall and degrades within 6-9 months, leaving behind the cobalt chromium alloy metal stent surface to achieve excellent clinical outcomes. The DESyne system was evaluated in the EXCELLA BD randomized clinical trial that enrolled patients in Europe and Brazil.

The results showed that at six months, the Elixir DESyne BD stent demonstrated not only noninferiority but also superiority over the Endeavor Zotarolimus Eluting Coronary Stent System, a product of Medtronic (Fridley, MN, USA), for the primary endpoint of in-stent late lumen loss. Similarly, there was a statistical difference in favor of DESyne BD for the secondary end point of binary restenosis. In a subset of patients who underwent intravascular ultrasound (IVUS) imaging, the findings mirrored the angiographic results, demonstrating a statistically significant reduction in percent neointimal obstruction for the DESyne BD stent versus the Endeavor stent. The DESyne BD Novolimus Eluting Coronary Stent System is a product of Elixir Medical Corporation (Sunnyvale, CA, USA), and has received the European Union CE marking.


“The CE Mark approval validates the impressive clinical results demonstrated with this stent system, including excellent efficacy and no cases of stent thrombosis through the one-year endpoint,” said Alexandre Abizaid, MD, PhD, from the Instituto Dante Pazzanese de Cardiologia (Sao Paulo, Brazil), coprincipal investigator for the EXCELLA BD clinical trial. “The combined attributes of lowest polymer load, lowest drug dose, and thin stent struts provides physicians with a state-of-the-art workhorse product that raises the bar for treating patients with coronary artery disease.”

“The CE Mark approval for the DESyne BD system is a major milestone for Elixir. It reinforces the excellent safety and effectiveness achieved with the CE Mark approved DESyne system, and positions Elixir as the only company to offer both durable and biodegradable polymer DES systems,” said Motasim Sirhan, CEO of Elixir Medical. “Elixir remains committed to providing interventional cardiologists with the broadest and most innovative product portfolio to advance patient care. Elixir intends to launch the DESyne BD system in a broad range of sizes.”

Novolimus, an active metabolite of Sirolimus, is a novel mTOR inhibitor macrocyclic lactone with antiproliferative and anti-inflammatory properties. Sirolimus is the most widely known mTOR inhibitor with a well-established safety and effectiveness profile in various treatment applications such as drug eluting stents, transplant, and oncology. Patients treated with Sirolimus orally or via DES implantation are exposed to significant amounts of Novolimus.

Related Links:
Elixir Medical Corporation
Medtronic
Instituto Dante Pazzanese de Cardiologia