Sunnyvale, CA, September 25, 2012 -- Cardiva Medical, Inc. announced today that it has obtained approval from the British Standards Institution (BSI) notified body to apply the European CE Mark to its VASCADE Vascular Closure System (VCS). Approval to apply the CE Mark was based, in part, on a successful prospective, multi-center clinical trial conducted in Australia and New Zealand.
"We are extremely pleased to have achieved this key Company milestone for our VASCADE VCS product," said Charles Maroney, CEO. “We are building a product portfolio that offers physicians and hospitals a choice for vascular closure for all patients undergoing percutaneous procedures through the femoral artery.” Mr. Maroney continued, “VASCADE is designed to offer competitive advantages over conventional vascular closure devices. Our earlier product, Catalyst, is designed to offer competitive advantages over manual compression, which is still the standard of care in many institutions. With both products, Cardiva will be ideally positioned to offer safe and effective closure solutions for all 10 million percutaneous femoral access procedures performed world-wide every year.”
VASCADE is designed to be as easy to use as Catalyst and to provide reduced time to hemostasis, ambulation and hospital discharge eligibility in the interventional catheterization lab. Using VASCADE, the physician deploys a thrombogenic collagen patch at the extra-vascular surface of the vessel arteriotomy site without an intra-vascular component. The Catalyst manual compression assist device is designed to be an adjunct to manual compression facilitating arteriotomy closure. Catalyst is based on the same technology platform as VASCADE, but does not include an extravascular collagen patch.
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.