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CYPHER® Stent specifications

CYPHER® Cardiac Stent A stent is a permanent implant that remains in your artery.

The CYPHER® Stent is a small, expandable, slotted metal tube that is inserted into a coronary artery, one of the blood vessels that supply the heart with oxygen and nutrients. The stent acts as a scaffold to help hold the artery open in order to improve blood flow to the heart and relieve the symptoms caused by the blockage.

The CYPHER® Stent is a drug-eluting stent.

The metal of the stent has a soft, plastic coating that contains the anti-rejection-type medicine sirolimus. It slowly releases this medicine into the artery wall around the stent to help limit the normal overgrowth of tissue as the healing process takes place. Eighty percent (80%) of the sirolimus is released during the first 30 days. The rest is released by the end of 90 days.

Detailed Information on the CYPHER® Stent:

Stent Geometry Closed-cell FLEXSEGMENT
Technology
Material 316L Stainless Steel
Strut Thickness .0055"
Crimped Profile .044"
Available Sizes Diameters: 2.50, 2.75, 3.00, 3.50 mm
Lengths: 8, 13, 18,23, 28, 33 mm
Drug Delivered Sirolimus (rapamycin, Rapamune)
Mechanism of Action Inhibits m TOR to block growth factor
induce proliferation
Cytostatic (blocks cell cycle in late
G1phase)
Drug Delivery Vehicle Controlled-release, nonresorbable,
elastomeric polymer coating
Drug Release Kinetics 80% of sirolimus released in 30 days
Approval Status Approved worldwide

Instructions for using the CYPHER® Stent:

Inflation Pressure Recommendations
  Inflation Pressure
    atm          (kPa)
2.50mm 2.75mm 3.00mm 3.50mm
6           608 2.17 2.43 2.64 3.13  
7           709 2.25 2.51 2.72 3.23  
8          811 2.32 2.58 2.80 3.32  
9          912 2.38 2.67 2.87 3.40  
10          1013 2.44 2.71 2.94 3.47  
11          1115 2.49 2.76 2.99 3.52  Nominal
12          1216 2.53 2.82 3.03 3.57
13         1317 2.56 2.51 2.72 3.23  
14         1419 2.59 2.87 3.11 3.64  
15         1520 2.62 2.89 3.14 3.67  
16         1621 2.64 2.92 3.16 3.70  RBP
17         1723 2.67 2.95 3.19 3.73  
18         1824 2.69 2.97 3.22 3.76  
19         1925 2.73 2.99 3.24 3.79  
20         2026 2.74 3.02 3.27 3.82  
Note:-The values are representative of average stent/balloon diameters at specific balloon inflation pressures obtained during in vitro-testing at 37 deg C. These values do not take into account lesion resistance. The Stent sizing should be confirmed angiographically. Do not exceed the rated burst pressure(RBF). Bolded Text represents diameters at pressure above the rated burst pressure. The values between the nominal pressure and the rated burst pressure are within +/- 10% of the labeled stent diameter

For health care professionals interested in ordering the CYPHER® Stent, contact the Cordis Medical Information Center at 1-800-781-0282.

Last modified date 8/8/2008 9:00 PM
Part#:155-6513-3