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Development and Initial Clinical Experience with AltaSeal®: a Novel Hysteroscopically Placed Permanent Contraception System

  • Emerging and Pipeline Technologies in Ob/Gyn (M Levie, Section Editor)
  • Published:
Current Obstetrics and Gynecology Reports Aims and scope Submit manuscript

Abstract

Purpose of Review

The purpose of this paper is to review the development and clinical evaluation of AltaSeal® which is being developed as an easy-to-use hysteroscopic sterilization implant. The implant made from 316 LVM bio-compatible stainless steel has been tested in clinical trials both for its efficacy in preventing pregnancy and its ability to occlude fallopian tubes with hydrosalpinges ahead of in vitro fertilization (IVF) therapies.

Recent Findings

The clinical data to date suggests that when placed correctly, AltaSeal® can effectively prevent pregnancy. In an observational study of patients with hydrosalpinges, AltaSeal® data suggests that the fallopian tubes are effectively closed by the AltaSeal® implants, thereby increasing IVF efficacy.

Summary

The results to date suggest that AltaSeal® can efficiently occlude fallopian tubes for both the prevention of pregnancy and possibly return the success rate of IVF in patients with hydrosalpinges to levels seen in patients without hydrosalpinges. Further clinical studies are ongoing to expand the clinical data.

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References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

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Author information

Authors and Affiliations

  1. AltaScience Ltd., Trinitas House, 2012 Orchard Ave, Citywest, Dublin, Ireland

    James E. Coleman

  2. Department of Obstetrics and Gynaecology, Máxima Medisch Centrum, Veldhoven, The Netherlands

    Marlies Bongers

  3. Department of Obstetrics and Gynaecology, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands

    Sebastiaan Veersema

  4. Department of Obstetrics and Gynaecology, Academic Medical Centre Amsterdam Medical Centre, Amsterdam, The Netherlands

    Andreas Thurkow

  5. Department of Obstetrics and Gynaecology, Midland Regional Hospital, Mullingar, Westmeath, Ireland

    Michael J. Gannon

Authors
  1. James E. Coleman
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  2. Marlies Bongers
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  3. Sebastiaan Veersema
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  4. Andreas Thurkow
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  5. Michael J. Gannon
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Corresponding author

Correspondence to James E. Coleman.

Ethics declarations

Conflict of Interest

James E. Coleman declares that he is the Co-Founder and Clinical Director of AltaScience. He also declares patents issued and pending regarding IP on which the technology is based which are owned by JE Coleman.

Marlies Bongers declares that she has no conflicts of interest.

Sebastiaan Veersema declares personal fees from Bayer and Johnson & Johnson for serving as a consultant and/or speaker, and patents pending (Hysteroscopic Shaft—Olympus, and Obstetrical Cutting Instrument—Gynaecologiq).

Andreas Thurkow declares compensation from AltaScience for time invested in the study, which was donated to the department’s scientific foundation, and personal fees as compensation for time invested in advisory board membership and speaker’s fee from Hologic, Johnson & Johnson, Olympus, and Gedeon Richter, and compensation for time invested in expert panel from Bayer.

Michael J. Gannon declares personal fees and non-financial support as aid for clinical time and research nurse from AltaScience and also declares to being a shareholder in AltaScience Ltd.

Due to the nature of this section and the anticipation of bias from the authors as it pertains to this article topic, the article has been reviewed by Dr. James Greenberg of Brigham and Women’s Hospital and by Dr. Mark Levie of Montefiore Medical Center. Both reviewers do not have any conflict of interest with the product reviewed in the article, and they assert that the article is factual and free of excessive bias toward the subject.

Human and Animal Rights and Informed Consent

All patients recruited to trials discussed in this article signed Regulatory Authority and Ethics Committee approved informed consent forms. This article does not contain any studies with animal subjects performed by any of the authors.

Additional information

This article is part of the Topical Collection on Emerging and Pipeline Technologies in Ob/Gyn

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Coleman, J.E., Bongers, M., Veersema, S. et al. Development and Initial Clinical Experience with AltaSeal®: a Novel Hysteroscopically Placed Permanent Contraception System. Curr Obstet Gynecol Rep 6, 74–81 (2017). https://doi.org/10.1007/s13669-017-0198-y

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  • DOI: https://doi.org/10.1007/s13669-017-0198-y

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