European regulators approved St. Jude Medical’s (NYSE:STJ) next-generation Amplatzer Amulet heart implant, a device used to close the heart’s left atrial appendage in patients at risk of stroke due to non-valvular atrial fibrillation.
The Amplatzer Amulet, which is delivered through the heart via a catheter, features some of the same elements as its predecessor, the Amplatzer Cardiac Plug, but is designed to treated a wider range of anatomies, according to a press release.
The device connects to the left atrial appendage, a tube-shaped structure where an estimated 90% of all blood clots form in patients with atrial fibrillation.
The Amplatzer Amulet blocks the opening of the LAA, minimizing the opportunity for clot formation and preventing clots from migrating into the bloodstream
The new Amplatzer device comes in more sizes than its predecessors, and is also pre-loaded into a delivery catheter to simplify the implantation procedure, according to a press release.
"Feedback from implanting physicians who have used our 1st-generation product has been instrumental to improving an already successful device," St. Jude cardiovascular & ablation technologies president Frank Callaghan said in prepared remarks. "We are pleased to offer a next-generation LAA occluder that addresses a wider range of patient anatomies, is easier to implant, and has the potential to further reduce the incidence of stroke in AF patients."
St. Jude has had some troubles with its other devices in its Amplatzer suite, taking a hit in October 2012 after studies found that the company’s Amplatzer PFO Occluder failed to significantly reduce cryptogenic stroke compared with standard treatment with drugs. The news dragged STJ shares down 4% in one day as the company attempted to highlight the positive elements of the study results.*
St. Jude at the time pointed out that the data may have been skewed by a quirk in the study’s design that meant that 3 of the 9 patients in the study who never received the implant were included in the device arm. Excluding those patients, and patients in the drug treatment cohort who dropped drug therapy, the risk of stroke was 63% lower for patients treated with the Amplatzer PFO Occluder device.
*Correction filed January 22, 2013 at 11:20 a.m.: The Amplatzer device referenced in this study was a patent foramen ovale occluder, a separate product line from the Amplatzer Amulet left atrial appendage occluder referenced in the headline.
