FDA Gives the Nod to 3 St. Jude Medical Pacemakers

Posted in Implantable Devices by Arundhati Parmar on March 24, 2014

FDA has approved three pacemakers made by St. Jude Medical including the Allure Quadra that brings a new kind of pacing technology to traditional pacemakers sold in the U.S.

St. Jude Medical announced Monday that the Minnesota device maker received FDA approvals for three new pacemakers.

This means that American patients will be able to access its Allure Quadra Cardiac Resynchrpnization Therapy pacemaker for the first time. The Allure Quadra CRT-P brings quadripolar pacing technology to the U.S., that allows physicians more pacing configurations within the heart that are not possible through traditional bipolar systems, the company noted in its announcement.

The Allure-Quadra pacemaker

"In International markets where the Allure Quadra CRT pacemaker is available, we experience strong demand and significant share capture as the technology has become the standard of care for many physicians,” said Eric S. Fain, group president at St. Jude Medical, in the news release.

The news release also quoted a physician.

"Adding the clinical benefits of quadripolar technology to pacemakers will expand the benefits of this therapy to patients. These features and additional pacing options will allow me to provide better care to patients diagnosed with heart failure and reduce the need for repeat procedures, especially for those patients who have been historically hard to treat due to tissue damage in their heart.,” said Dr. Raffaele Corbisiero, chair of electrophysiology and pacing and director of the Electromechanical Therapy Institute at the Deborah Heart and Lung Center in Browns Mills, N.J. “This could have economic benefits as well due to fewer readmissions for heart failure-related events.”

In addition to the Allure Quadra, St. Jude also announced that FDA had approved the Assurity and Endurity pacemakers. The products are expected to be launched by the end of March. 

In the fourth quarter, pacemaker sales increased slightly to $263 million globally, from $260 million in the fourth quarter of 2012.  


[Feature Photo Credit: user Tolimir]


-- By Arundhati Parmar, Senior Editor, MD+DI



Printer-friendly version
No votes yet

Login to post comments