Synergy bioabsorbable polymer drug-eluting stent system (Boston Scientific) for treatment of coronary artery disease
HAYES, Inc.
Record ID 32016000794
English
Authors' recommendations:
Description of Technology: This report focuses on the use of the Synergy stent system for the treatment of coronary artery disease. According to the manufacturer, the Synergy stent is mounted over an expandable balloon attached to a delivery catheter. The Synergy stent consists of a thinstrut (74, 79, or 81 micrometers) platinum-chromium (PtCr) alloy lattice (platinum, chromium, iron, nickel, and molybdenum) coated—only on the side that will contact the blood vessel wall—with an ultrathin (4 micromoles per liter) bioabsorbable Poly(D,L-lactide-co-glycolide) polymer mixed with the immunosuppressive drug everolimus (drug density is 1 microgram per square millimeter) to inhibit blood vessel wall cellular reproduction that might lead to a new blockage (restenosis) in the stent. Shortly after the drug has eluted (in approximately 3 months' time), the polymer coating is completely absorbed, leaving a bare PtCr stent.
Patient Population: The Synergy stent system is intended for improving luminal diameter in adult patients with symptomatic heart disease, stable angina, unstable angina, non-ST-elevation MI, or documented silent ischemia due to atherosclerotic lesions in native coronary arteries 2.25 millimeters (mm) to 4.0 mm in diameter in lesions 34 mm in length. Use of the Synergy stent system in pediatric patients has not been established. The use of the Synergy stent has not been studied in pregnant women or men who want to father children, nor have the effects of the stent on fetal development and lactation. How sex and/or ethnicity might
affect efficacy and safety of the stent is not clear.
Details
Project Status:
Completed
Year Published:
2016
URL for published report:
The report may be purchased from:
http://www.hayesinc.com/hayes/crd/?crd=38046
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
United States
MeSH Terms
- Humans
- Angioplasty, Balloon, Coronary
- Coronary Artery Disease
- Drug-Eluting Stents
- Polymers
Contact
Organisation Name:
HAYES, Inc.
Contact Address:
157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218
Contact Name:
saleinfo@hayesinc.com
Contact Email:
saleinfo@hayesinc.com
Copyright:
2014 Winifred S. Hayes, Inc
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