Synergy DES with "bioabsorbable" coating gets CE Mark

October 31, 2012

Natick, MA - The Synergy everolimus-eluting coronary stent (Boston Scientific), with a bioabsorbable polymer coating that eventually disappears after releasing the drug, has received the CE Mark, which clears the way for sale in Europe[1].

In its statement, Boston Scientific said it plans to make the stent available to "select centers in Europe and other geographies" in early 2013 and more broadly the following year. The Synergy remains investigational in the US and Japan.

The stent represents a new approach to PCI, pursued also by other stent manufacturers, aimed at reducing inflammation commonly caused by drug-eluting stent coatings and thereby, it's hoped, improving healing and cutting the risk of in-stent thrombosis. In the case of Synergy, absorption of the polymer coating leaves behind a bare platinum-chromium stent.

In the EVOLVE study, which as reported by heartwire randomized 192 patients with de novo lesions to receive either Synergy or Boston Scientific's already-available Promos Element, the Synergy emerged as "noninferior" based on angiographic end points.

A much larger, randomized EVOLVE 2 study is currently enrolling and slated to support Synergy's eventual case for approval to the US FDA.


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