Cardiva Medical, Inc. Announces U.S. FDA Approval for VASCADE Vascular Closure System

Wed Feb 6, 2013 7:01pm EST

* Reuters is not responsible for the content in this press release.

For best results when printing this announcement, please click on the link

SUNNYVALE, Calif.,  Feb. 6, 2013  /PRNewswire/ -- Cardiva Medical, Inc. today
announced that the U.S. Food and Drug Administration (FDA) has granted Premarket
Approval (PMA) for the VASCADE Vascular Closure System (VCS). Clinical data from
a prospective, multi-center, randomized 420 patient trial demonstrated that the
VASCADE VCS is clinically and statistically superior in both safety and efficacy
compared to manual compression, the gold standard for vascular closure for
patients undergoing percutaneous procedures through the femoral artery.  

"We are thrilled to receive PMA approval for VASCADE," said  Charles Maroney,
President and CEO. Maroney continued, "We appreciate the effort of our clinical
investigators who worked with us to achieve this important milestone and
establish a new 3rdgeneration closure technology.  Cardiva is well positioned to
bring this technology to the marketplace to increase patient throughput and
provide a safer and more effective alternative to manual compression across  the
United States."

James Hermiller, M.D. of The Heart Center,  Indianapolis, who served as
Principal Investigator for the trial said, "I am extremely pleased with the
outstanding clinical performance of VASCADE and with the extraordinary
contributions by over 65 clinical investigators and their staff at over 20
clinical sites in the U.S and  Australia  who facilitated the study. With PMA
approval, VASCADE will now be available in the U.S. to all physicians who need
safe and effective vascular closure."

Frank Zidar, M.D., clinical investigator at The Heart Hospital of  Austin 
commented, "VASCADE is a new generation of extravascular closure technology that
offers significant advantages over conventional closure devices and manual
compression. I am excited to be able to provide VASCADE to my patients and to
integrate it into my practice."

VASCADE, an extravascular closure device, utilizes a unique delivery system
based on a proprietary collapsible disc technology that provides temporary
hemostasis during the procedure which eliminates the need for an intra-vascular
component. Secure and rapid hemostasis is achieved with VASCADE by the
deployment of a thrombogenic resorbable collagen patch at the arteriotomy of the
femoral artery.  

About Cardiva Medical, Inc      

Cardiva Medical, Inc. is a privately-held, medical device company that designs,
develops and commercializes femoral access closure products which help the body
heal itself following percutaneous catheterization procedures.  Annually, more
than 13 million percutaneous catheterization procedures worldwide require
closure.  In 2005, Cardiva launched its first product into the vessel closure
market, the Boomerang Wire System, which demonstrated excellent ease-of-use and
safety.  In 2008, Cardiva launched the Cardiva Catalyst II, which incorporates
hemostatic agents to accelerate the body's own coagulation pathway; facilitating
hemostasis at the arteriotomy site, preserving the artery and leaving absolutely
nothing behind in the patient. In 2009, Cardiva launched the Catalyst III system
that is coated with protamine sulfate which neutralizes heparin in the tissue
tract and facilitates hemostasis in patients anticoagulated with heparin. In
2012, Cardiva received CE Mark registration for the VASCADE VCS.  

For additional information about Cardiva, please visit our website at

Boomerang, Boomerang Catalyst and Cardiva Catalyst are intended as adjuncts to
manual compression and are registered trademarks of Cardiva Medical, Inc.

Media Contact:  
Malcolm Farnsworth
Chief Financial Officer
Cardiva Medical, Inc.
Phone: 650-388-8555

SOURCE  Cardiva Medical, Inc.

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.