St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced approval from the U.S. Food and Drug Administration (FDA) for the Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which provides additional pacing innovations for physicians to treat patients with heart failure. The company also announced FDA approvals for the Assurity™ pacemaker and Endurity™ pacemaker families of devices.
The Allure Quadra (TM) Cardiac Resynchronization Therapy Pacemaker (CRT-P) from St. Jude Medical, Inc. (Photo: Business Wire).“St. Jude Medical is the leader in quadripolar pacing technology, provided in our high voltage CRT-D devices since 2009. 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, M.D., group president at St. Jude Medical. “Through product offerings like the Allure Quadra CRT-P and the Assurity and Endurity pacemakers, we continue to deliver innovation through a full continuum of pacemaker options.” Allure Quadra CRT-P The Allure Quadra CRT-P system brings quadripolar lead technology to the U.S. pacemaker market for the first time. Quadripolar technology facilitates additional pacing configurations within the heart that offer physicians options not available in traditional bipolar systems. These additional options help physicians to manage common pacing complications without exposing the patient to additional surgeries for lead repositioning. To date, more than 100 clinical publications have provided broad clinical evidence in support of the advantages of quadripolar technology from St. Jude Medical. The Allure family of devices also offers enhanced heart failure (HF) diagnostics that can help with patient monitoring and offer insights into disease progression and management. Device information from the Allure Quadra CRT-P is automatically transmitted to the secure St. Jude Medical website, Merlin.net™ Patient Care Network (PCN) as well as to the patient’s electronic health record, where the information can be viewed by medical professionals. “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.”