Sunnyvale, CA, August 2, 2012 -- Cardiva Medical, Inc. announced that it has submitted the final module of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its VASCADE Vascular Closure System (VCS). Cardiva’s PMA submission includes safety and efficacy data in a prospective, multi-center, randomized 420 patient trial comparing VASCADE to manual compression at 20 leading medical institutions in the United States and one site in Australia.
“Completing our PMA submission is a significant milestone for Cardiva. We are pleased with the results of the clinical trial and look forward to working with the FDA on the PMA review to bring the VASCADE VCS to physicians and patients in the United States,” said Charles Maroney, President and Chief Executive Officer.
The VASCADE system’s unique delivery system is based on proprietary technology used in the Company's first product line, Catalyst. Using VASCADE, the physician deploys a thrombogenic collagen patch at the arteriotomy at the extra-vascular surface of the vessel without an intra-vascular component. VASCADE is designed to be as easy to use as Catalyst and is intended to offer competitive advantages over conventional VCDs.
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 12 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 January 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 May 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.
For additional information about Cardiva, please visit our website at www.cardivamedical.com.
Boomerang®, Boomerang Catalyst® and Cardiva Catalyst® are intended as adjuncts to manual compression and are registered trademarks of Cardiva Medical, Inc.
Chief Financial Officer
Cardiva Medical, Inc.