CE Mark for a New Embolic Protection System During TAVI

Claret Medical, Inc. announced today that its Montage System has received CE Mark approval as the world’s first complete system of filtration to protect both carotid arteries simultaneously. The 6F catheter is delivered via radial or brachial access, providing complete neuro protection during intravascular procedures such as Transcatheter Aortic Valve Intervention (TAVI).  The unique design of the Montage System provides for not only neuro-protection from debris, but also for capturing and removing potential stroke causing embolic material from the body. “The CE Mark approval for the Montage System is an exciting new step forward to potentially reduce stroke rates in TAVI and other vascular procedures,” said Prof. Eberhard Grube, M.D., F.A.C.C., F.S.C.A.I., Director of the Structural Heart Program at University Hospital in Bonn, Germany.  “The timing of this innovation could not be better, in that it has the potential to change the way physicians view TAVI in their practice.”

The Montage System is the first of its kind to protect carotid arteries and capture embolic debris during TAVI

“The Montage System was surprisingly elegant and simple to deliver,” notes Alexander Abizaid Director, Catheterization Laboratory, Institute Dante Pazzanese, Sao Paolo, Brazil.  “We, along with other investigators, were astounded at the volume of debris we found in the filters and were delighted we could provide a solution to help capture and remove this material from the patient’s vascular circulation.”

This is the second product approval for Claret Medical in 2011.  These approvals were supported by data from the clinical trial in Europe, which included 30-day patient follow-up.  “The CE Mark approval for the Montage System is an important milestone for Claret, and stems from the incredible dedication of our team to improving patient-care during TAVI,” stated Randy Lashinski President and CEO of Claret.  To further study the device in an expanded population, Claret plans to initiate additional controlled clinical trials outside of the United States early next year.

Source: Claret Medical