CONTENTS
December 1995 |
Characteristics and Distribution
TCu-380A and TCu-380 Slimline (TCu-380S)Description: Polyethylene with barium sulfate added for visibility on x-rays. 314 mm2 copper wire on vertical stem; two 33 mm2 solid copper sleeves on each transverse arm. On the 380S the copper sleeves are placed at the ends of the arms and recessed into the plastic. Developers: Population Council (US) and Ortho Canada (TCu-380S). Date first marketed: 1982 (TCu-380A). Major distributors: TCu-380A—FEI Products, US; P.T. Kimia Farma, Indonesia; Produtos Medicos Ltda., Brazil; Ortho-McNeil, US (brand name ParaGard); Schering AG, Commonwealth of Independent States (CIS) (formerly USSR); TCu-380A and TCu-380S (brand name Gyne T Slimline)—Janssen-Ortho Canada; TCu-380S—Janssen-Cilag, Russia; Cilag, France. Length: 36 mm. Width: 32 mm. Strings: Two white (formerly blue). Inserter type and diameter: Withdrawal; 4.4 mm. (Both use the same inserter tube. TCu-380S arms fit completely in tube. With TCu-380A only the tips of the arms fit inside tube.) Lifespan demonstrated in clinical trials: 10 years. Approved lifespan: TCu-380A—US, 10 years; CIS, 6 years. TCu-380S—Canada, 2-1/2 years; Europe, various. Areas of major use: TCu-380A—worldwide; TCu-380S—Canada, Western Europe, Hong Kong.
Description: Polyethylene with barium sulfate added for
visibility on x-rays. 200 mm2 copper wire wrapped around stem.
The TCu-200B (shown) has a ball at the tip of the stem; the
TCu-200 does not.
Developers: Howard Tatum (US) and Jaime Zipper (Chile).
Date first marketed: 1972.
Major distributors: TCu-200B—Produtos Medicos Ltda., Brazil;
TCu-200—Janssen-Ortho Canada.
Length: 36 mm. Width: 32 mm.
Strings: Two; color varies.
Inserter type and diameter: Withdrawal; 4.4 mm.
Lifespan demonstrated in clinical trials: 6 years.
Approved lifespan: US, 4 years; various European countries, 3
years; Canada, 2 years.
Areas of major use: Bangladesh, India.
Description: Polyethylene with barium sulfate added for
visibility on x-rays. Nova T (shown) has 200 mm2 copper wire
with a silver core wrapped around the stem. CuNovaT has 380 mm2
wire wrapped around the stem.
Developers: Leiras Oy, Finland.
Date first marketed: Nova T—1979; CuNovaT—1994.
Major distributors: Nova T—Leiras Oy in Scandinavian
countries; Schering AG in other countries worldwide; also
Pharmacia (Novagard) in UK. CuNovaT—Leiras Oy.
Length: 32 mm. Width: 32 mm.
Strings: Two brown.
Inserter type and diameter: Withdrawal; 3.6 mm.
Approved lifespan: Nova T and CuNovaT—5 years in various
European countries.
Lifespan demonstrated in clinical trials: Nova T—5 years;
CuNovaT—3 years to date.
Areas of major use: Nova T—Europe, Canada, Asia and Pacific;
CuNovaT—Denmark, Finland, Norway, Sweden.
Description: Polyethylene with barium sulfate added for
visibility on x-rays. Available in four sizes, designated A
(left) through D (right).
Developer: Jack Lippes (US).
Date first marketed: 1962.
Major distributor: P.T. Kimia Farma, Indonesia (in-country
distribution only).
Length: A—26.2 mm; B—25.2 mm; C—27.5 mm; D—27.5 mm.
Width: A—22.2 mm; B—27.4 mm; C—30.0 mm; D—30.0 mm.
Strings: Two; A—blue, B—black, C—yellow, D—white.
Inserter type and diameter: Push-out; 4.7 mm.
Areas of major use: Formerly, worldwide except China; currently,
Indonesia.
Description: Polyethylene with two flexible arms with spurs. The
MLCu-250 has 250 mm
Developer: W.A.A. van Os (Netherlands).
Date first marketed: 1974.
Distributors: Produced by Multilan AG, Switzerland, in Ireland
and by Nanjing Organon Pharmaceutical Products, China.
Distributed through subsidiaries of NV Organon, the Netherlands,
member of AKZO-NOBEL Pharma Division; Laboratoires CCD, France.
Also manufactured for in-country use in Indonesia.
Length: Standard (250 and 375)—35 mm; 375SL—29 mm; 250 Short—24 mm.
Width: All types—18 mm.
Strings: Two blue or colorless.
Inserter type: Withdrawal (no plunger).
Insertion diameter: All types—12 mm (arms remain outside
inserter tube).
Lifespan demonstrated in clinical trials: MLCu-375--5 years.
Approved lifespan: MLCu-250—3 years; MLCu-375—5 years.
Areas of major use: Europe (including Russia and other members of
the Commonwealth of Independent States), Australia, India,
Vietnam and other Southeast Asian countries, New Zealand, Latin
America.
Description: Polyethylene with barium sulfate added for
visibility on x-rays. 220 mm
Developer: Population Council (US).
Date first marketed: 1980.
Major distributors: Laboratorios Alpha, Mexico; Tianjin Medical
Instrument Corporation, Factory No. 4, China (in-country
distribution only).
Length: 36 mm. Width: 32 mm.
Strings: Two.
Inserter type and diameter: Withdrawal; 4.4 mm.
Lifespan demonstrated in clinical trials: 10 years.
Approved lifespan: Mexico, 3 years.
Areas of major use: China, Mexico
Description: Ethylene vinyl acetate copolymer. Vertical stem
contains a reservoir of 38 mg progesterone and barium sulfate
(for visibility on x-rays) in silicone oil base. Releases 65 micrograms
progesterone per 24 hours.
Developer: Alza Corporation (US).
Date first marketed: 1976.
Distributors: Alza Corporation, US; Theraplix Divison, Rhone-Poulenc
Rorer, France.
Length: 36 mm. Width: 32 mm.
Strings: Two blue-black.
Inserter type and diameter: Withdrawal; 8 mm.
Approved lifespan: US, one year; France, 18 months.
Areas of major use: US, France.
Description: Polyethylene T frame surrounded by a
levonorgestrel-containing cylinder. The cylinder is covered with
a rate-controlling membrane. The release rate is 20 micrograms
levonorgestrel per 24 hours.
Developers: Leiras Oy with the Population Council.
Date first marketed: 1990 in Finland.
Major distributors: Leiras Oy in Scandinavian countries and
Asia-Pacific, Pharmacia-Leiras in selected European countries.
Length: 32 mm. Width: 32 mm.
Hormone cylinder: length 19 mm, outer diameter 2.8
mm, inner diameter 1.2 mm.
Strings: Two brown.
Inserter type and diameter: Withdrawal; 4.75 mm.
Lifespan demonstrated in clinical trials: 5 years.
Approved lifespan: UK, 3 years; other countries, 5 years.
Areas of major use: Denmark, Finland, Norway, Sweden. Launched in
UK and Singapore in 1995. Also approved for use in Belgium,
France, Iceland, and Switzerland. |