Modified FlexStent® Biliary Self Expanding Stent System receives FDA 510(k) SE Clearance
EATONTOWN, NJ - (Business Wire) - Flexible Stenting Solutions, Inc. (FSS), a leading developer of next generation peripheral arterial, venous, neurovascular and biliary stents, announced today that it has received 510(k) clearance for an improved FlexStent® Biliary Self Expanding Stent Delivery System and an expansion of Biliary stent sizes.
The FlexStent® Biliary Self Expanding Stent System is indicated for the palliative treatment of biliary strictures resulting from malignant neoplasms. Expansion of the FlexStent® Biliary Stent size range provides the physician with additional options in the treatment of these strictures. FSS's nearly fully connected stent has always allowed for a straight forward, simple and accurate delivery. The delivery system improvement builds on the already easy to use system assuring even lower deployment forces thus enabling the physician to quickly perform each deployment.
"FSS continues to be customer and ease-of-use focused," commented Janet Burpee, FSS's CEO. Ms. Burpee further stated that "The modified FlexStent® Biliary Stent Delivery System has been designed for improved manufacturing and lower stent deployment force. FSS's goal is to simplify the procedure so the physician can focus on the patient."
About Flexible Stenting Solutions Inc.
Flexible Stenting Solutions Inc. (FSS) is a leading developer of third-generation flexible peripheral arterial, venous, neurovascular and biliary stents. Its fully connected stent has coupled technology with clinical needs by providing an atraumatic, highly durable and fatigue resistant stent with superior radial stiffness, flexibility and conformability. FSS is an ISO 13485:2003 certified company and has received regulatory approvals on several products.
For further information on Flexible Stenting Solutions, please visit the company website at www.flexiblestent.com.
FlexStent® is a registered trademark of Flexible Stenting Solutions, Inc.