First U.S. Implant of St. Jude’s First-to-Market “CRT-D”

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St. Jude Medical, Inc. recently announced the U.S. launch and the first U.S. implant of its Quadra Assure MP cardiac resynchronization therapy defibrillator (CRT-D).  The Quadra Assura MP features St. Jude Medical’s first-to-market  MultiPoint Pacing (MPP) technology.  The device received CE Mark Approval for MRI Compatibility in December 2015 and the MPP technology received U.S. FDA approval earlier this year. According to the press release, the first implant of the Quadra Assura MP took place at Saint Francis Hospital in Hartford, Connecticut.

Heart failure patients frequently experience ventricle contraction or beating that is out of sync.  CRT synchronizes the ventricle contraction.  According to the press release, the first-to market MPP technologies allow physicians to pace multiple locations on the left side of the patient’s heart.  According to the American Heart Association, “heart failure (HF) is a chronic, progressive condition in which the heart muscle is unable to pump enough blood through to meet the body’s needs for blood and oxygen.”  The condition affects over 5.8 million in the USA and over 23 million worldwide.  Despite the success of CRT, according to a recent study, one third of the HF patients fail to respond to CRT.  The same study shows that MPP optimizes the response of such non-responsive patients to CRT.  According to St. Jude, MPP is also featured on St. Jude Medical’s Quadra Allure MP CRT-pacemaker (CRT-P) and two new Quartet Quadripolar LV Leads.St. Jude Medical, Quadra Asssura CRT-D, Quadra Assura MP, MR conditional labeling, CE Mark

Regarding the first implant, Dr. Mark D. Carlson, Chief Medical Officer and Vice President, Global Clinical Affairs, at St. Jude Medical, stated:

St. Jude Medical developed and established a new standard of care for CRT with quadripolar pacing. We are excited to bring the next-generation MultiPoint Pacing technology to market, giving physicians additional options to improve patient response.

Dr. Neal Lippman, electrophysiologist with Arrhythmia Consultants of Connecticut, added:

We are now able to offer St. Jude Medical’s new MultiPoint Pacing technology for our patients whose heart failure condition is difficult to manage. It is important for us to have this option to individualize patient care and help improve response to therapy.

According to its website, St. Jude Medical is a global medical device manufacturer, headquartered in St. Paul, Minnesota and focuses on six key treatment areas: heart failure, arrhythmias, vascular disease, structural heart, chronic pain, and neurological diseases.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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