Device: Elixir's DESolve 100 Novolimus Eluting Bioresorbable Coronary Scaffold System
CE mark: Yes (2013 and 2014 for second-generation device)
U.S. clinical trials: None
Elixir Medical is the race's plucky underdog. The privately held Silicon Valley-based company doesn't have access to the same amount of capital as Abbott ($ABT), but it hopes to eventually steal market share from the current leader due to the thinner strut profile of its CE-marked DESolve 100, which should hit the market in 2015. For now, the first-generation DESolve device isn't widely available in Europe, unlike Abbott's Absorb.
The company declined to share any details about its plans for a U.S. launch, but an EvaluateMedTech article posted on the company's website said that it plans to seek permission from the FDA to start clinical trials this year.
|Elixir's DESolve stent--Courtesy of Elixir|
The first-generation DESolve device, which the company says biodegrades in about a year, earned a CE mark in May 2013. That milestone was followed by a CE mark for the upgraded DESolve 100 a year later. "100" refers to the 100-micron (0.1-millimeter) thickness of the polymer layer that forms the perimeter of the stent and supports its coating, compared to about 150 microns for the Absorb. Note that the term "strut" profile refers to the thickness of the polymer layer itself, not the overall diameter of the stent.
GlobalData research analyst Priya Madhavan says the decreased thickness of DESolve 100's polymer layer gives it a technical advantage over the Absorb because having less material that must dissolve lowers the risk of restenosis, or the formation of scar tissue that results when the immune system attacks foreign objects in the body. In addition, a European study of registry data said that the BVS's strut thickness may be contributing to the device's worryingly high rate of stent thrombosis, or the formation of blood clots that block the stent.
In other respects, the DESolve 100 is similar to Abbott's Absorb. Both are made of a lactic acid polymer and elute a drug from the limus family. Elixir's novolimus formulation is slightly different from Abbott's everolimus version, but it is unclear which is superior, Madhavan said. The second-generation DESolve device will also be available in sizes from 2.5 to 3.5 millimeters in diameter.
The DESolve was evaluated in the 126-patient DESolve Nx clinical trial in 13 centers in Europe, Brazil and New Zealand. It posted a 5.7% rate of major adverse cardiac events at one year, and patients had a mean lumen gain of 5.5 millimeters, according to the company's statement.
Elixir is also working on obtaining FDA approval of its DESyne drug-eluting stent and began enrolling patients in that product's clinical trial last year.
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