Two Deaths Tied to Cardiac Device Battery
St. Jude Medical has reported a risk that a battery issue could disable its high-voltage cardiac rhythm management devices.
The lithium-based batteries utilized in the implantable cardioverter defibrillators and cardiac resynchronization therapy devices could develop “lithium clusters” during high-voltage charging. The clusters could then cause a short circuit and drain the battery in as little as 24 hours.
The company has received reports of 841 devices with this issue among its 398,470 implanted cardiac devices sold worldwide.
The problem affects ICDs and CRT-Ds made before May 23, 2015, the company said.
Graft Device Gets Breakthrough Designation
The FDA has granted breakthrough therapy designation to Gamida Cell’s NiCord device, which is in development as a graft modality for bone marrow transplantation in patients with high-risk blood cancers.
Data from the initial study and Phase I/II of NiCord have demonstrated significant improvement in neutrophil engraftment over cord blood transplantation, including fewer infections, reduced hospital recovery time, quicker platelet engraftment and improved non-relapse mortality when compared to new cord blood transplantation.
Potential Contamination Spurs Filter Recall
Baxter Corp. has issued a recall for its 50 mm 0.2 Micron Filter after receiving information on particulate matter and potential absence of filter membrane layers in the filter set. The absence may lead to contamination of a solution and risk of bloodstream infections.
The disposable filter is used to filter bacteria and other microscopic matter when preparing water-based solutions used for IV administration sets.
The lots being recalled were distributed globally between Aug. 22, 2013, and June 20, 2016.
The recall affects unexpired batches with code #H93835 that expire in the time frame of June 27, 2016 to June 27, 2019.
There are 130,100 units in the U.S. subject to this recall.
FDA Clears St. Jude Guidewire System
St. Jude Medical has received FDA marketing clearance for its PressureWire X Guidewire, which is designed to improve percutaneous coronary intervention (PCI) procedures in patients with complex anatomies.
The device is a fractional flow reserve measurement system and is the latest development of the PressureWire Guidewire system portfolio.
The device is used during PCI procedures to identify the severity of constriction in the coronary arteries.
There are nearly 900,000 PCI procedures performed annually in the U.S., but only one in five are performed using fractional flow reserve technology, according to St. Jude.