Flexible Stenting Solutions (FSS; Eatontown, New Jersey) said it has received 510(k) clearance for its FlexStent biliary self-expanding stent system. The device is indicated for the palliative treatment of biliary strictures resulting from malignant neoplasms.
Janet Burpee, CEO of FSS, told Medical Device Daily that the company has no immediate plans for putting the device on the market yet. She said FSS is figuring out its launch strategy in the U.S. as well as in Europe.
"We're currently really focusing on development, getting product ready across the board," Burpee said.
FSS says its 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 company said. The key to the delivery technology is simplicity, ease of use and placement, FSS noted.
"We are very excited about receiving 510(k) marketing clearance and were thrilled to participate in the FDA's STED review process," Burpee said. "We believe our unique platform technology will continue to provide needed clinical solutions in the interventional radiology, gastroenterology, neurovascular and cardiology device marketplace."
Burpee said that the FlexStent biliary self-expanding stent is "very, very conformable," which she says is what sets it apart from other biliary stents on the market.
The company has also received CE mark authorization for the Biliary and Femoropopliteal FlexStent systems.
Earlier this year FSS reported receiving CE-mark approval for the FlexStent biliary self-expanding stent system (Medical Device Daily, March 9, 2009).
The privately held company raised $6 million in a venture financing round with GBP Capital in January 2008.
Last month FSS signed an exclusive agreement with Micrus Endovascular (San Jose, California) to jointly develop a flow diversion technology for neurovascular indications using both Micrus and FSS technology development capabilities and intellectual property. According to Micrus, flow diversion is a relatively new approach for treating large and giant aneurysms which represent roughly 20% to 25% of treated intracranial aneurysms. Unlike microcoils that are placed in the aneurysm, flow diverters are stent-like devices placed in the parent vessel. They serve to divert blood flow away from the aneurysm, thus facilitating healing, Micrus said.
Micrus said it would be responsible for overseeing the regulatory and clinical process and will manufacture neurovascular products developed based on the agreement. Micrus said it has made an upfront payment to FSS and will make additional payments upon achieving certain development and regulatory milestones. Micrus will also pay a royalty on net sales of products incorporating the FSS platform.
Amanda Pedersen, 229-471-4212;