Concept Medical MagicTouch AVF DCB Study Gains FDA IDE Approval

April 2, 2024—Concept Medical announced it has been granted FDA investigational device exemption (IDE) approval to initiate a clinical study for its MagicTouch AVF sirolimus-coated balloon catheter for the management of stenotic arteriovenous fistula (AVF) lesions.

The IDE approval will allow Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data on the MagicTouch sirolimus-coated balloon in AVFs and support a future FDA premarket approval application.

The company anticipates initiating the MagicTouch AVF IDE clinical trial in the coming month. Concept Medical also noted that the MagicTouch portfolio has received four other IDE approvals for different indications and is on track to begin enrolling in those trials in the United States.

Concept Medical received FDA Breakthrough Device designation for MagicTouch AVF in August 2019.