Pre-Procedure Review: UPDATE

CONFORM Clinical Trial Investigators and Coordinators,

Effective July 11, 2025, the pre-procedure review process has been updated to remove the requirement for a Pre-Procedure Review Slide Deck to be completed for cases 2-5.

Additionally, the clarification has been made that the first approved case per implanter requires the 1:1 call and the slide deck. If the patient is determined not to be suitable, the requirements still apply to the next patient. Below is an updated chart with highlighted changes that reflects the new process.

Please contact your assigned Conformal Site Manager with any questions about this update.

Regards,

Aly Dechert | Manager of Clinical Operations

Have suggestions or questions about this newsletter?

Drop us a note at info@conformalmedical.com.

CAUTION: Investigational Device

The CLAAS System is limited by Federal (or United States) law to investigational use.

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