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Proven safety, efficacy, and patient satisfaction

EASE Study Overview1

The EASE study was conducted to demonstrate the safety and effectiveness of Adiana Permanent Contraception in 645 women from ages 18 to 45. It was a prospective, single-armed, multi-center, multi-national study that used findings from the U.S. Collaborative Review of Sterilization (CREST) study as a qualitative benchmark. The trial showed a strong safety profile, with very high device placement success, patient tolerance, comfort and satisfaction.

Primary Efficacy Endpoint:

Pregnancy prevention rate after 12 months of reliance on the matrices for contraception

Secondary Endpoints:

  • Device placement rates
  • Patient satisfaction and comfort with the placement procedure
  • Patient satisfaction and comfort during the reliance phase

Adiana Efficacy

98.4% 3-year pregnancy prevention effectiveness rate as shown in the clinical trial

Adiana Safety1

No uterine or fallopian perforations
No adverse device reactions – no allergic reactions, no infections
No removals

Device Placement1

95% (611/645) successful bilateral placements

Anesthesia1

No patients required general anesthesia

Adiana Procedure Time1

11 minutes 54 second average procedure time

Patient Comfort & Satisfaction1

99% of patients were “very satisfied” or “satisfied” with the procedure
98% rated their tolerance of the procedure as “well” to “excellent”
98% of patients returned to normal activities in 1 or 2 days

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Bibliography

Adiana Bibliography as of 3-27-10

  1. Rehan M, Coleman J, Olabi AG. Novel implant for transcervical sterilization. Journal of Bioscience and Bioengineering. 2010. [Epub ahead of print]. http://ees.elsevier.com/jbiosc/
  2. Tatalovich JM, Anderson TL. Hysteroscopic sterilization in patients with a Mirena intrauterine device: Transition from extended interval to permanent contraception. J Minim Invasive Gynecol. 2010;17(2):228-231. http://www.ncbi.nlm.nih.gov/pubmed/20226413
  3. Smith, RD. Contemporary hysteroscopic methods for female sterilization. Int J Gynaecol Obstet. 2010;108(1):79-84. http://www.ncbi.nlm.nih.gov/pubmed/19716128
  4. Palmer SN, Greenberg JA. Transcervical sterilization: a comparison of Essure® permanent birth control system and Adiana® permanent contraception system. Rev Obstet Gynecol. 2009;2(2):84-92. http://www.ncbi.nlm.nih.gov/pubmed/19609402
  5. Rowlands S. New technologies in contraception. BJOG. 2009;116(2):230-239. http://www.ncbi.nlm.nih.gov/pubmed/19076955
  6. Hurskainen R, Hovi S-L, Gissler M, Grahn R, Kukkonen-Harjula K, Nord-Saari M, Makeka M. Hysteroscopic tubal sterilization: a systematic review of the Essure system. Fert Stert. 2009. [Epub ahead of time] http://www.ncbi.nlm.nih.gov/pubmed/19409549
  7. Vancaillie TG, Anderson TL, Johns DA. A 12-month prospective evaluation of transcervical sterilization using implantable polymer matrices. Obstet Gynecol. 2008;112(6):1270-1277. http://www.ncbi.nlm.nih.gov/pubmed/19037035
  8. Greenberg JA. Hysteroscopic sterilization: history and current methods. Rev Obstet Gynecol. 2008;1(3):113-121. http://www.ncbi.nlm.nih.gov/pubmed/19015762
  9. Abbott J. Transcervical sterilization. Curr Opin Obstet Gynecol. 2007;19(4):325-330. http://www.ncbi.nlm.nih.gov/pubmed/17625413
  10. Ogburn T, Espey E. Transcervical sterilization: past, present, and future. Obstet Gynecol Clin North Am. 2007;34(1):57-72. http://www.ncbi.nlm.nih.gov/pubmed/17472865
  11. Turok D. The quest for better contraception: Future methods. Obstetrics and Gynecology Clinics of North America. 2007;34(1):137-166. http://www.ncbi.nlm.nih.gov/pubmed/17472865
  12. McSwain H, Brodie MF. Fallopian tube occlusion, an alternative to tubal ligation. Tech Vasc Interv Radiol. 2006;9(1):24-9. http://www.ncbi.nlm.nih.gov/pubmed/17145482
  13. Hastings-Tolsma M, Nodine P, Teal SB. Essure: Hysteroscopic Sterilization. J Midwifery Womens Health. 2006;51:510-514. http://www.ncbi.nlm.nih.gov/pubmed/17081943
  14. Abbott J. Transcervical sterilization. Best Pract Res Clin Obstet Gynaecol. 2005;19(5):743-56. http://www.ncbi.nlm.nih.gov/pubmed/16023892
  15. Vilos GA, Abu-Rafea B. New developments in ambulatory hysteroscopic surgery. Best Pract Res Clin Obstet Gynaecol. 2005;19(5):727-42. http://www.ncbi.nlm.nih.gov/pubmed/16126460
  16. Garza-Leal J, Hernandez I, Castillo L, Livengood R, Stillman M, Coad JE. Feasibility of Hysterosalpingography To Evaluate Tubal Occlusion Following Concomitant Adiana® Transcervical Sterilization and NovaSure® Endometrial Ablation. J Minim Invasive Gynecol. 2009;16(6):S112-S113. http://www.jmig.org/
  17. Garza-Leal J, Castillo L, Hernandez I, Costas M, Stillman M , Coad JE. Concominant Use of Adiana® Permanent Contraception and NovaSure® Impedance Controlled Endometrial Ablation: A Peri-Hysterectomy Study. J Minim Invasive Gynecol. 2009;16(6):S69. http://www.jmig.org/
  18. Vancaillie TG, Harrington D, Carr-Brendel V, Anderson J. Mechanism of Action of the Adiana Device: A Histologic Perspective. J Minim Invasive Gynecol. 2009;16(6):S70. http://www.jmig.org/
  19. Anderson TL, Vancaillie TG. Adiana System for Transcervical Sterilization: 3-Year Efficacy Results. J Minim Invasive Gynecol. 2009;16(6):S38. http://www.jmig.org/
  20. Bongers MY, Veersema S. Evaluating the Learning Curve for a Novel Hysteroscopic Sterilization Technique. J Minim Invasive Gynecol. 2009;16(6):S83. http://www.jmig.org/
  21. Vancaillie TG. Tubal Occlusion With the Adiana Device Appears to Improve Outcome in Patients Undergoing IVF. J Minim Invasive Gynecol. 2007;14(6):S102. http://www.jmig.org/
  22. Anderson TL, Presthus J. Procedural Characteristics of the Adiana Transcervical Sterilization System. J Minim Invasive Gynecol. 2007;14(6):S6. http://www.jmig.org/
  23. Johns DA. Advances in Hysteroscopic Sterlization: Report on 600 Patients Enrolled in the Adiana Ease Pivotal Trial. J Minim Invasive Gynecol. 2005;12(5):39-40 Supplement. http://www.jmig.org/
  24. Vancaillie TG, Herbst SJ, Harris MS, Presthus J, Anderson TL, Johns DA. Adiana hysteroscopic sterilization: Interim results of the EASE clinical trial. The Journal of the American Association of Gynecologic Laparoscopists. 2004;11(3):S30. http://www.jmig.org/
  25. Vancaillie TG, Herbst S, Harris M, Cooper JM, Galen DI, Zimmerman J. The Adiana procedure: Early results of the ease clinical trial. The Journal of the American Association of Gynecologic Laparoscopists. 2003;10(3):S6. http://www.jmig.org/
  26. Vancaillie TG, Garza-Leal JG, Stewart DR. Adiana transcervical sterilization: Ingrowth results twelve weeks post-treatment. The Journal of the American Association of Gynecologic Laparoscopists. 2002;9(3):S58. http://www.jmig.org/
  27. Vancaillie TG, Garza-Leal JG, Stewart DR. Adiana transcervical sterilization: Tubal access rate in healthy patients. The Journal of the American Association of Gynecologic Laparoscopists. 2002;9(3):S58. http://www.jmig.org/
  28. Vancaillie T, Stewart DR, Garza-Leal JG. A new transcervical sterilization procedure. The Journal of the American Association of Gynecologic Laparoscopists. 2001;8(1):S72-S73. http://www.jmig.org/
  29. Stewart DR, Vancaillie T, Garza Leal JG. Fallopian tube tissue response, a new transcervical sterilization procedure. The Journal of the American Association of Gynecologic Laparoscopists. 2001;8(3):S67. http://www.jmig.org/
  30. Vancaillie T, Stewart Dr, Garza Leal JG. Testing the individual tube by a new pressure test. The Journal of the American Association of Gynecologic Laparoscopists. 2001;8(3):S73. http://www.jmig.org/
  31. Carr-Brendel VE, Stewart DR, Harrington DC, Garza-Leal, JG, Vancaillie. A new transcervical sterilization procedure: results of a pilot implant study in humans. Obstet Gynecol. 2001;97(4):S8.
  32. Carr-Brendel, Stewart DR, Harrington DC, Dhaka VK, Breining PM, Vancaillie T. A new transcervical sterilization procedure – 6 month preclinical results. Obstet Gynecol. 2001;97(4):S15-S16.
  33. Bowman BS, Carr-Brendel VE, Dhaka VK, Harrington DC, Vancaillie T. New transcervical sterilization procedure: optimal epithelial ablation. Obstet Gynecol. 2001;97(4):S16.

1. Vancaille TG, Anderson TL, Johns DA. A 12-month prospective evaluation of transcervical sterilization using implantable polymer matrices.Obstet Gynecol 2008;112:1270-1277.

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