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The SYNERGY Stent provides synchronized drug and polymer absorption. It is designed to enable more rapid and complete arterial healing, and to thereby reduce the risk of complications associated with long-term polymer exposure compared to currently-used drug-eluting stents (DES) with permanent polymers.
Existing DES devices reduce coronary restenosis, but the polymer remains on the stent after the drug is delivered. Long-term exposure to the polymer may cause inflammation, which delays healing and has been associated with complications, including neoatherosclerosis and stent thrombosis. The SYNERGY Stent is designed for faster and sustained healing by eliminating long term polymer exposure.
'Data from the EVOLVE II trial, which included the most complex patient population studied in a U.S. regulatory approval stent trial, demonstrated exceptional performance and safety of the SYNERGY Stent,' said
Results previously reported from EVOLVE II, a global, multi-center, randomized, single-blind, non-inferiority pivotal trial demonstrated 0% definite stent thrombosis (ST) after 24 hours. Four-year EVOLVE trial data demonstrated a continued 0% stent thrombosis rate and a very low target lesion revascularization (TLR) rate of 1.1%.
'The introduction of the first bioabsorbable polymer stent in the U.S. is a tremendous milestone in the evolution of stent technology,' said
About the SYNERGY Bioabsorbable Polymer Stent
The SYNERGY Stent is the only bioabsorbable polymer stent available to patients in the U.S. It features ultrathin stent struts with an abluminal bioabsorbable drug/polymer coating technology that is absorbed shortly after drug elution is complete at three months, thereby eliminating long-term polymer exposure. Obtain more information on the SYNERGY Clinical Program and Research in the U.S. Information is also available for those outside the U.S.
The SYNERGY Stent received CE Mark in 2012. View or download an image of the SYNERGY Stent.
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Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like 'anticipate,' 'expect,' 'project,' 'believe,' 'plan,' 'estimate,' 'intend' and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding new product launches and launch cadence, regulatory approvals, clinical trials and impact of data, product performance and impact and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
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CONTACTS
Media:
Trish Backes
Boston Scientific Corporation
(651) 582-5887 (office)
trish.backes@bsci.com
Investors:
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
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