First EU Commercial Implant of DESolve® Novolimus Eluting Coronary Scaffold System

Back in May 2013 we covered the CE marking of Elixir Medical’s DESolve Novolimus Eluting Coronary Scaffold. Now a first commercial implantation has been performed in Germany.

Background

Bioresorbable scaffolds, despite having been mooted for a few years, remain a relatively recent phenomenon in cardiovascular, specifically coronary artery interventions. The challenge for developers has been to come up with a construct that delivers the strength and support that previously only permanent metallic stents had been able to provide while degrading in a timely manner and maintaining excellent clinical outcomes.

Elixir is claiming that its DESolve Novolimus Eluting Bioresorbable Coronary Scaffold overcomes these challenges and achieves vascular restoration within six months.

When it ultimately dissolves, the DESolve scaffold leaves behind it restored blood flow to the heart and a treated artery that can function and move more naturally because it is free of a permanent implant. Developed from a proprietary and proven poly-L Lactide (PLLA)-based polymer, Elixir claims that DESolve provides optimal strength and support to the artery while delivering the novel anti-proliferative drug, Novolimus.

Elixir says the DESolve scaffold system uniquely maintains radial strength and provides vessel support for the necessary period of vessel healing before being fully degraded in one year. They claim an increased vessel lumen area within six months and a self-apposing characteristic means the stent will expand to the vessel wall up to the nominal deployed diameter. This in turn is coupled with a wide margin of expansion.

The first implantation was performed by Professor Dr. med. Holger Nef, Head of the Cardiac Catheterization Laboratory, University Hospital Giessen, Giessen, Germany.

The DESolve roll out will now follow at initial centers in Europe. The scaffold is currently available in diameters of 3.0, 3.25 and 3.5 mm and lengths of 14, 18 and 28 mm with additional sizes becoming available during 2014.

Physician comments

Prof Nef stated; “The fully bioresorbable DESolve System is easy to deliver. The acute performance of the scaffold demonstrated excellent stent apposition to the vessel wall and low recoil, and the patient is doing well. I am confident that Elixir’s scaffold system will drive forward the field of vascular intervention.”

Company comments

“Elixir is proud to fulfill its commitment of providing the broadest and most innovative product portfolio for cardiologists to address their patients’ needs,” said Motasim Sirhan, President and Chief Executive Officer of Elixir Medical. “The fully bioresorbable DESolve Scaffold System holds the promise of transforming the interventional cardiology industry by raising the bar in clinical outcomes and leaving no permanent implant behind.”

Source: Elixir Medical, Inc., Business Wire

 

 

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