The Web implant is made of a Nitinol mesh that is delivered in a “stent-like” manner and deployed into the pouch formed by an aneurysm in order to prevent blood from flowing in. Sequent won CE Mark approval for the Web system in 2010, and is running an FDA-approved investigational device exemption pivotal trial as it seeks U.S. clearance.
The acquisition will included an extra $100 million dependent on the achievement of specific development or commercial milestones, according to a press release from Terumo.
Tokyo-based Terumo said the acquisition is a “key element” in its new growth strategy to expand its global presence in the neurovascular and other growing markets. The company said it is also looking at the cardiology and endovascular markets as targets for growth through M&A.
Last week, Terumo said it received a notice from the FDA lifting all shipping restrictions at its Ann Arbor, Mich. facility that were imposed in 2011 as part of the company’s consent decree.
The step is the 2nd and final phase of the company’s work plan to remediate products manufactured at the facility to comply with the FDA’s requirements, Terumo said.
The federal watchdog performed an inspection in May and reported that it found “no inspectional observations,” Terumo said.
DeviceTalks Minnesota's leadership track is designed to provide attendees with insights on topics such as:
Use code SAVE15 to save 15%!