Philips wins FDA nod for 3D TAVI planning software
August 21, 2014 by Brad Perriello
Philips said the FDA granted 510(k) clearance for its 3D planning software for a type of heart valve replacement procedure, part of Philips’ IntelliSpace Portal 6 visualization and analysis platform.
The planning software for transcatheter aortic valve implantations “features a comprehensive measurement package to accommodate virtually all types of TAVI devices,” according to a press release. Read more
Direct Flow wins CE Marks for TAVI device
August 21, 2014 by Brad Perriello
Direct Flow Medical said today that it won CE Mark approval in the European Union for an additional size of its replacement heart valve, plus an EU OK for the use of the devices without contrast media.
EuroZone regulators approved the 23mm size of Direct Flow’s transcatheter aortic valve implant, expanding its valve portfolio to 23mm, 25mm, 27mm and 29mm valves, according to a press release. The devices are designed to reduce the paravalvular leakage that was a problem with earlier versions of TAVI devices and can be re-positioned “until optimal results are obtained,” according to the release. Read more
FDA OKs return of Covidien's Pipeline embolism device
August 21, 2014 by Brad Perriello
Covidien said today that an FDA clearance means it can get its Pipeline brain embolism device back on the U.S. market immediately, nearly 5 months after a voluntary recall of the Pipeline coil and the Alligator retrieval device.
Covidien recalled some of the Pipeline and Alligator devices in April, after internal testing revealed a potentially lethal problem with the guidewires used to deliver them. No patient incidents were reported in relation to the problem with a plastic coating used in both devices. Read more
FDA delays UDI rule for contacts, intraocular lenses
August 20, 2014 by Arezu Sarvestani
Makers of contact lenses and intraocular lenses are getting a 1-year reprieve after the FDA agreed to shift their due date for complying with Unique Device Identifier rules.
Manufacturers successfully lobbied for a delay after demonstrating that requirements for lenses would create a massive burden for both device makers and regulators. Read more
Cardiovascular Systems recalls some Diamondback devices on embolism risk
August 19, 2014 by Brad Perriello
Cardiovascular Systems is recalling some of its Diamondback 360 atherectomy devices on the risk that a component could shatter and possibly block a blood vessel.
Although no injuries have been reported as a result of the potential issue, the FDA said today that the recall is Class I, denoting a problem that could lead to serious injury or death. Read more
