Edwards Lifesciences won a CE mark for its innovative aortic valve system. European approval for the device comes at a critical moment for the company, as it attempts to strengthen its hold on foreign markets and stay a step ahead of its competition.
Boston Scientific nabbed a new CE mark that allows one of its esophageal stents to be used to treat narrowing of the esophagus caused by benign scar tissue--another win as the company seeks to restore steady revenue expansion after a years-long slump.
Stentys now has key CE mark approval to use its self-apposing stent to treat acute heart attacks in a broader class of patients.
Veniti, a Missouri device startup developing venous disease treatments, has nailed down more than $9.7 million of an anticipated $12 million round of venture financing from 15 investors, according to a regulatory filing.
Medtronic is debuting a new surgical tool in Europe designed to help surgeons perform osteotomies to treat severe spinal curvature in adults. The launch comes in tandem with a new CE mark.
Teleflex picked up European approval to market its GPSCath device, designed to prop open vessels and reduce procedure times for vascular interventions.
In the fiercely competitive global stent market, Abbott seems to view size as mattering most.
Tryton Medical won a CE mark for a short version of its Side Branch Stent to treat bifurcated lesions, a crucial step toward reaching more patients and pursuing the company's U.S. approval pathway.
St. Jude Medical ($STJ) scored European regulatory approval for a new quadripolar cardiac resynchronization therapy pacemaker. And with an immediate commercial rollout, the company gains another product that could help reverse sluggish revenue in the sector.
Apollo Endosurgery is making its first foray into Europe, backed by a new CE mark for two of its products that enable incision-less surgery while using a flexible endoscope.