TransForm™ Occlusion Balloon Catheter Registry

TransForm™ Occlusion Balloon Catheter Registry

The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures

• This is a prospective, single-arm, non-randomized, multi-center, observational registry.
• The expected duration for study enrollment is approximately 6 months-1 year.
• Study participation for each subject will be completed upon removal of the guide catheter post-procedure.
• Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be allowed to enroll a maximum of 20 subjects.
• Enrollment in the registry occurs after a signed Informed Consent Form has been obtained, and the index procedure starts.

Inclusion Criteria:

1. Subject or legal representative is willing and has provided informed consent.
2. Subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter.
3. Subject is over 18 years of age.

Exclusion Criteria:

1. Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
2. Subject's pregnant