Scion Cardio-Vascular Inc has received CE Marking for its revolutionary Sci-Pro filter protection device. CE Marking (Conformite Europene) is required for selling medical devices in Europe. Approval is a very rigorous, quality and regulatory process that opens the door to continued growth for the Sci-Pro and Scion Cardio-Vascular. "The CE Marking is the result of the Company's dedication to quality excellence and regulatory compliance," said Ramon Augusto Paz, Scion Cardio-Vascular's Director of Regulatory Affairs and Quality Systems.
The Sci-Pro is a technologically advanced and elegantly simple guidewire-based filter and retrieval system designed to provide protection during interventional surgical procedures such as peripheral circulatory percutaneous transluminal angioplasty (PTA) and stenting. The device is as simple to use as an ordinary guidewire and is designed to provide distal protection, while serving as an embolic material retriever. The product uses a proprietary push/pull system to open and close a nitinol basket and requires no delivery sheath, which in turn allows an extremely low crossing profile.
Scion Cardio-Vascular has completed an extensive animal trial on the Sci-Pro Distal Protection Device with Steven R. Bailey, Director of Interventional Cardiology at the University of Texas Health Science Center San Antonio. Dr. Bailey is a world-renowned pioneer in interventional cardiovascular procedures. "The device was extremely easy to use and tracked very well in tortuous vessels," said Dr. Bailey. "The Sci-Pro has a low crossing profile and controllable deployment, even with angioplasty balloons loaded on the device. I found the product to be very effective."
"Scion Cardio-Vascular has completed numerous market preference studies in various centers throughout the world and the feedback has always been extremely positive," said Ernest Manzano, the Company's Director of Sales & Marketing. "The comments, 'easiest to use' and 'lowest profile' are heard repeatedly." With the CE Marking, Scion-Cardio-Vascular is well positioned and ready to enter the European market with the Sci-Pro.