Healthcare Industry News:  transcatheter 

Devices Interventional Regulatory

 News Release - February 27, 2013

Claret Medical, Inc. Announces CE Mark Approval of Montage 2(TM) and Live Case Debut During JIM 2013

The Montage 2 is the only approved filter system protecting the carotid arteries capturing embolic debris during intravascular procedures such as transcatheter Aortic Valve Repair (TAVR).

SANTA ROSA, Calif., Feb. 27, 2013 -- (Healthcare Sales & Marketing Network) -- Claret Medical, Inc. announced today that its 2nd generation filtration system, Montage 2 Dual Filter System received CE Mark approval with an innovative catheter handle furthering the simplicity and ease of use of the technology while providing complete neuro-protection and embolic capture during intravascular procedures such as TAVR.

Montage 2 was featured during a live case at the Joint Interventional Meeting (JIM 2013) in Rome earlier this month. The case was performed by Professor George Nickenig and Professor Eberhard Grube, both of University Hospital, Bonn, Germany. After an explanation of the improved handle, Professor Nickenig demonstrated significant debris capture using Montage 2 and commented, "There is a lot of material captured here, that you want to have in the filter and not in the brain."

Claret Medical continues to expand its extensive clinical experience demonstrating significant debris capture during TAVR procedures, irrespective of the valve type used. Most recently Dr. John Webb, St. Paul's Hospital, Vancouver, Canada, began using Montage 2 during a TAVR procedure. "We have been impressed at the extent of embolic material we have been able to retrieve," commented Dr. Webb. The Montage 2 technology was also used by Elisabeth-Krankenhaus at the Contilia Heart and Vascular Centre, Essen Germany. "I have been delighted to see advancements in the Montage 2 delivery system, and our ability to protect TAVR patients from risk of embolic neurological deficit," noted Professor Christoph Naber, Managing Director of the center.

This is the third product approval for Claret Medical, demonstrating its leadership in embolic protection during TAVR. "We believe embolic capture and removal provides patients the best protection from exposure to neurological harm during TAVR procedures," stated Randy Lashinski President and CEO of Claret Medical. "We are excited that our vision continues to be clinically validated by such leaders in the clinical community."

About Claret Medical

Claret Medical is a privately-held company focused on innovative solutions for cerebral protection during vascular intervention and surgery. Claret Medical is currently directing developmental and clinical resources to address stroke during TAVR, a significant unmet clinical need.

www.claretmedical.com


Source: Claret Medical

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