Clinical Development


 

AltaSeal® Clinical Data: Permanent Contraception Studies

AltaSeal Clinical Results Summary

  • 3 trials (AltaSeal® I-III)

  • Reliance data on >90 women (180 Tubal Placements)

  • Over 6 years of reliance data

  • No pregnancies

  • Excellent safety profile

  • 530 woman years, no pregnancies

  • 5 device removals, easily performed Laparoscopically

 
 

 

Clinical Data in Patients with Hydrosalpinx Treated with AltaSeal prior to Undergoing IVF

AltaSeal® Clinical Results

  • 17 women recieved AltaSeal prior to IVF treatment

  • Successful pregnancies in 10 out of 17 patients

  • 8 out of 10 patients (47% of original 17) had 10 healthy babies

  • 5-year final report: no DR SAE’s

 
 

 

AltaSeal® - Visual Confirmation 

(8 individual women)

 
 

 

Implant Visibility with Ultrasound and Fluoroscopy

AltaSeal® is clearly visable by both trans-vaginal ultrasound and abdominal ultrasound


TS view of both AltaSeal® implants  

 

Effectiveness as shown by HSG (a type of x-ray)


 

THIS DEVICE IS NOT YET FOR SALE IN THE UNITED STATES

– IT IS AN INVESTIGATIONAL DEVICE LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.