Sunnyvale, CA, June 20, 2012 -- Cardiva Medical, Inc. announced the completion of patient enrollment in the RESPECT Clinical Trial (Rapid Extravascular Sealing via PercutanEous Collagen ImplanT) in the U.S. for the VASCADE Vascular Closure System (VCS). The RESPECT trial was designed as a prospective, multi-center, randomized 420 patient trial comparing VASCADE to manual compression, the conventional method used to close the femoral artery after catheterization. Over 65 physicians participated in the trial at 20 leading medical institutions in the U.S. An additional site in Australia participated. James Hermiller, M.D. of The Heart Center, Indianapolis served as Principal Investigator for the trial. The Company plans to submit the clinical section of its modular Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) in July of this year and is anticipating product approval in early 2013. The VASCADE VCS is intended to reduce time to hemostasis, ambulation, and discharge eligibility as compared with manual compression.
The Company also announced that it has completed a CE Mark trial and submitted the results for approval to market VASCADE in the European Union. The CE Mark trial was an open-label, prospective, multi-center clinical trial conducted in Australia and New Zealand.
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 quick and efficient vessel closure 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.