Medical devices giant St. Jude Medical (STJ) has commenced the European roll-out of its “Unify Quadra” cardiac resynchronization therapy defibrillator (“CRT-D”). The small quadripolar pacing system enables physicians to more effectively manage the pacing needs of patients with heart failure (inability of the heart to pump enough blood).

Roughly 14 million people are affected by heart failure in Europe, a figure which is expected to leap to around 30 million by 2020. The condition leads to more than 3.6 million hospitalizations annually in the continent.

Cardiac resynchronization therapy (“CRT”), delivered through implantable cardioverter defibrillator (“ICD”) or a pacemaker, resynchronizes the beating of the heart’s lower chambers that often beat abnormally in patients with heart failure. CRT has been found to be effective in improving the quality of life in many patients with heart failure.

St. Jude launched the quadripolar technology in Europe in 2010 by introducing the “Promote Quadra” CRT-D and is currently the only company to offer this technology globally. Promote Quadra combines multiple pacing configuration, features and programming options, allowing surgeons to optimize the device at the implant to better manage common pacing complications such as phrenic nerve or diaphragmatic stimulation, which can occur in patients implanted with a CRT system. Besides, it also reduces the need for surgical revisions.

Phrenic nerve or diaphragmatic stimulation takes place when an electrical output from a CRT device unintentionally activates the diaphragm muscle, resulting in major discomfort for patients. The complication generally occurs due to the location of left ventricular (“LV”) pacing lead electrode.

Unify Quadra represents an advancement over Promote Quadra, offering all the benefits of quadripolar technology in a device with the smallest footprint in the industry. The device’s narrower shape allows surgeons to implant it through a smaller incision, leading to reduced time in closing the incision and a smaller scar for the patient.

Unify Quadra uses the “Quartet” LV pacing lead, the first lead to feature four pacing electrodes which can be used in up to ten pacing configurations. This provides a greater number of options and control and enables surgeons to place the lead in the most stable position and manage implant complications, resulting in improved patient outcome. Since the surgeon can adjust pacing locations or configurations, the technology has the potential to lessen the need for multiple surgeries.

St. Jude is poised for incremental opportunities in CRM riding on strong product momentum. Its Fortify and Unify devices are already gaining notable traction. Several new products should boost the company’s CRM share in 2011.

However, St. Jude and its peers Medtronic (MDT) and Boston Scientific (BSX) are fighting a turf war in the soft CRM market. The sustained weakness in this market may hurt the company’s CRM sales in 2011. Our Neutral recommendation on St. Jude is in line with a Zacks #3 Rank (Hold).


 
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