St. Jude Medical, Inc. has gained CE Mark approval of three new Quartet™ left ventricular (LV) leads, offering additional electrode spacing options and one new lead shape. The additional spacing combinations are aimed to more effectively target the individual cardiac anatomies of patients who need support from cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D).
Background
CRT resynchronizes the beating of the heart’s lower chambers (ventricles), which often beat out of sync in heart failure patients. The addition of MultiPoint Pacing™ technology enables physicians to program a single Quartet LV lead to pace multiple sites on the left side of the heart, giving the clinician more choices to improve patient response to therapy and reducing the likelihood of costly and invasive lead revision through a second intervention procedure.
The newly-approved additional quadripolar lead options are used with next-generation MultiPoint Pacing technology, which enables physicians to pace multiple locations on the left side of the heart and provide physicians a new option for patients who haven’t responded to CRT. With its expanded selection of quadripolar pacing leads, St. Jude Medical can now boast the largest quadripolar lead portfolio the broadest on the market, offering enhanced individualization of CRT. The new leads are designed based on the company’s first-to-market proven quadripolar LV lead technology and include additional spacing options on two new S-shape and one new double-bend lead designs.
Some of the newly approved products are also magnetic resonance (MR) – conditional, including the Quadra Assura™ CRT-D and Quadra Assura MP™ CRT-D with MultiPoint™ Pacing. Additionally, physicians will be able to quickly customize therapy using the Auto VectSelect Quartet™ Test, which is designed to automatically guide programming of the most appropriate therapy options available and streamline workflow.
Physician comments
“Heart and blood vessel anatomy vary from patient to patient so having multiple sizes and spacing options with the Quartet quadripolar lead helps me to treat all of my patients in need of cardiac resynchronization therapy. We are now able to place the quadripolar lead in the best possible location for that patient, capturing more cardiac tissue to give heart failure patients the best opportunity to respond,” said Dr. Sami Pakarinen, a cardiologist from Helsinki University Central Hospital in Finland.
Company comments
“These lead choices allow physicians to identify what lead spacing option will work best for each patient so they can individualize care,” said Philip B. Adamson, M.D., medical director and vice president of medical affairs at St. Jude Medical. “The expanded selection of quadripolar pacing leads reinforces St. Jude Medical’s leadership in quadripolar pacing and heart failure treatment options.”
Source: Business Wire, Image courtesy of St Jude Medical, Inc.
published: March 30, 2016 in: Approval/Clearance, Cardio, Launches / Withdrawals, St Jude