The Little Canada, Minn.-based company said it pulled implants of the micro-sized, catheter-delivered Nanostim after receiving 7 reports of “lost telemetry and pacing output.” The company clarified that there have been no reports of patient injuries associated with the malfunction.
“Patient safety is our top priority, and we are currently working to ensure our physician partners worldwide have the information they need to effectively manage their patients. We remain committed to developing leadless pacing technology and will continue to work to redefine the pacing options available to patients in the future,” chief medical officer Dr. Mark Carlson said in a statement emailed to MassDevice.com.
St. Jude is allegedly pursuing a software fix to detect any increase in the rate of battery problems, and may be in talks with a battery manufacturer to develop a different battery for the nanostim, according to a release from Barclays.
The banking firm claimed St. Jude is looking to submit an application for approval for the new battery in the 4th quarter of this year.
St. Jude has not responded yet to requests for more information on the battery issues.
Earlier today, St. Jude shareholders grudgingly approved a measure to give tax breaks to its senior execs if its pending $25 billion merger with Abbott (NYSE:ABT) goes through successfully. The same shareholders earlier this week voted to approve its pending, $25 billion merger.
The company’s board last year voted to do away with a “gross-up” provision that would have covered the 15% excise tax imposed by U.S. tax laws on stock owned by executives and directors for the 6 months before and after a merger transaction.
But after inking an $85-per-share deal in April to be acquired by Abbott, St. Jude moved to reinstate the gross-up provision, which could relieve CEO Michael Rousseau and other executives of $18 million in tax payments if they leave Abbott after the deal closes, expected by year-end.
St. Jude and Abbott still plan to close the deal, which must still pass reviews by anti-trust regulators in the U.S. and Europe, by the end of the year. In July, the Federal Trade Commission asked for more information about the merger; the European Commission is slated to decide by Nov. 9 whether to bless the union.