Abbott (NYSE:ABT) said this month that it’s maintaining the worldwide halt on implantations of the Nanostim leadless pacemaker made by its St. Jude Medical subsidiary after reports surfaced of problems with the device’s docking button.
The 3.6mm docking button is designed to allow the Nanostim device to be retrieved after implantation; it’s meant to connect with the retrieval catheter during removal. In a Nov. 17 letter to physicians, Abbott said it received three reports of docking buttons detaching, out of 1,423 Nanostim implantations (0.002%), with no serious injuries reported.
One of the cases occurred during a retrieval procedure, of which there have been 93 attempts worldwide, the Chicago-area healthcare giant said. Chest X-rays identified two cases several months after implantation, Abbott said, and the device either continued to be used or was deactivated and a new Nanostim implanted. In those cases the docking button was embedded in the right ventricle, according to the company. The retrieval case saw the docking button migrate to a sub-branch of the pulmonary artery, the company said.
“In all three cases that have occurred, there has been no impact to the electrical function (e.g., pacing, sensing, communication) and no clinical impact or symptoms resulting from the docking button detachment or exposed cables,” Abbott said. “Worldwide implants of the Nanostim device remain halted as Abbott continues to investigate the issue.”
The company advised doctors to continue following patients as recommended in October 2016, when St. Jude paused Nanostim implantations after receiving seven reports of “lost telemetry and pacing output” due to a battery issue. Retrieval should only be considered if X-rays show the docking button is intact and if the procedure can be performed according to the instructions for use, Abbott said.
“If a detached docking button has been identified, Nanostim LCP retrieval is not recommended. In the rare situation where retrieval is the only management option, please contact the Abbott Clinical Study Team for further guidance,” the company said.
Abbott acquired Jude for $25 billion early this year.