AltaSeal
- User: Female
- Hormonal: Non-Hormonal
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Delivery type:
- Fallopian Tube
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Intended Duration:
- Permanent
- Development Stage: Phase I
- Developer(s)/researcher(s): AltaScience
Details
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Mechanism of Action:
- Tubal Occlusion
- Inactive Materials: Stainless Steel
- MPT: Not Potential MPT
- Promising Attributes: AltaSeal's developers indicate that their product is easier to place consistently and less likely to cause fibrotic reaction than similar devices
Product Status
Active/Recent Clinical Research
History
AltaSeal, a sterilization implant placed in the fallopian tube with a proprietary, non-surgical delivery device, is intended to provide an in-office alternative to tubal ligation.
2010-2011: Perihysterectomy pilot study conducted with ten patients (20 bilateral placements of the AltaSeal device) in Amsterdam. Implants were successfully placed in only 9 out of 20 attempts, with 11 failures attributed to the presence of uterine fibroids in the patient population. In successful placements, AltaSeal was effective at closing fallopian tubes.
2011-2012: Pilot study conducted with 37 patients seeking permanent contraception. Full insertion failure documented in 8 patients, for whom the correct insertion process was not followed. The device was correctly inserted in remaining 29 and remained in place for 22 patients at the 12 week mark. In these 22 patients, no adverse events or pregnancies were reported 5 years following insertion.
2016-2017: Multi-center pivotal trial of modified AltaSeal device in 83 patients. Insertion attempted in 79 patients and successful in 66. Misplacements occurred in 10 participants. Trial is terminated to allow for redevelopment of the delivery system to lower rate of misplacement.
As of 2025, AltaScience continues to pursue funding and present at industry events.
Publications
doi: 10.1016/j.jmig.2011.08.133
doi: 10.1007/s13669-017-0198-y