EATONTOWN, N.J.--(BUSINESS WIRE)--Flexible Stenting Solutions Inc., a leading developer of next generation peripheral arterial and biliary stents, received 510(k) clearance for the FlexStent® Biliary Self Expanding Stent System.
The FlexStent® Biliary Self Expanding Stent System is indicated for the palliative treatment of biliary strictures resulting from malignant neoplasms. FSS’s nearly fully connected stent has coupled technology with clinical needs by providing a highly durable stent with superior radial stiffness and low chronic outward force. The key to the FSS stent technology is the integration of helically wound struts with helical flexible coils. The key to the delivery technology is simplicity, ease of use and placement.
“We are very excited about receiving 510(k) marketing clearance and were thrilled to participate in the FDA’s STED review process,” Janet Burpee, FSS’s CEO, commented. She added, “We believe our unique platform technology will continue to provide needed clinical solutions in the interventional radiology, gastroenterology, neurovascular and cardiology device marketplace.”
The company has also received CE Mark authorization for the Biliary and Femoropopliteal FlexStent® systems. FDA 510(k) clearance will allow expansion of current biliary device sale beyond Europe to the United States market.
About Flexible Stenting Solutions Inc.
Flexible Stenting Solutions Inc. (FSS) is a leading developer of third-generation flexible peripheral arterial and biliary stents. Its fully connected stent has coupled technology with clinical needs by providing a highly durable and fatigue resistant stent with superior radial stiffness, flexibility and conformability. FSS staged launch of products will provide clinical solutions throughout the body. FSS is an ISO 13485:2003 certified company and has received regulatory approvals on several products. For more information, visit the company’s website at www.flexiblestent.com.
FlexStent® is a registered trademark of Flexible Stenting Solutions, Inc.
Contacts
Flexible Stenting Solutions, Inc. Janet Burpee, CEO, 732-578-0060
