Veryan Submits BioMimics 3D Stent for FDA Approval

 

February 1, 2018—Veryan Medical announced it has submitted a premarket approval (PMA) application for the BioMimics three-dimensional vascular stent system to the US Food & Drug Administration (FDA).

The PMA application is supported by the 12-month interim safety and effectiveness results from the company's pivotal MIMICS-2 study in patients undergoing endovascular intervention to relieve obstructive or occlusive disease in the femoropopliteal artery. MIMICS-2 is being conducted under an FDA investigational device exemption with the concurrence of the Japanese Pharmaceuticals and Medical Devices Agency under their Harmonization by Doing collaboration. The MIMICS-2 data are also supporting the company's application for approval in Japan, which is expected to be submitted in Q1 2018.

According to the company, the MIMICS-2 study enrolled 271 patients undergoing femoropopliteal intervention across 43 investigational sites in United States, Japan, and Germany. Enrollment into the study was completed in 15 months. MIMICS-2 Coprincipal Investigator Prof. Thomas Zeller, MD, presented an analysis of the data at LINC 2018, the Leipzig Interventional Course, which showed that both 30-day freedom from major adverse events and 12-month primary patency endpoints were met and no stent fractures were detected.

 

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