US FDA approves St Jude Medical’s new pacemakers

24 March 2014 (Last Updated March 24th, 2014 18:30)

St Jude Medical has obtained US Food and Drug Administration (FDA) approvals for its Allure Quadra cardiac resynchronisation therapy pacemaker (CRT-P) and the Assurity and Endurity pacemakers.

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St Jude Medical has obtained US Food and Drug Administration (FDA) approvals for its Allure Quadra cardiac resynchronisation therapy pacemaker (CRT-P) and the Assurity and Endurity pacemakers.

Allure Quadra CRT-P brings the quadripolar lead technology to the pacemaker market for the first time, the company said.

Compared with traditional bipolar systems, the CRT-P system offers more pacing options within the heart to deliver higher success rates.

The additional options help manage common pacing complications without exposing the patient to additional surgeries for lead repositioning.

Until now, more than 100 clinical publications have provided broad clinical evidence in support of the advantages of St Jude Medical's quadripolar technology.

The Allure range of devices also offers enhanced heart failure diagnostics, including CorVue impedance monitoring, for improved patient management.

Device information from the Allure Quadra CRT-P is automatically transmitted to the secure St Jude Medical website, Merlin.net Patient Care Network, as well as to the patient's electronic health record, where the information can be viewed by medical professionals.

Designed for longevity, the Assurity and Endurity pacemakers feature a physician-inspired shape, early notification of atrial fibrillation-related events and pacing that helps reduce HF-related hospitalisations.

The Assurity and Endurity pacemakers are available as a single or dual chamber device (pacing either one or both chambers of the heart). They provide a higher level of care at implant and throughout patients' lives.

Using RF technology, the Assurity pacemaker automatically transmits device data to a physician or care team without any action by the patient.

While the Endurity pacemaker uses inductive telemetry for rapidly providing device data during interrogation.

"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."

The two pacemakers are supported by the Merlin.net Patient Care Network website for remote patient management.

St Jude Medical group president Dr Eric S Fain said that the company is the leader in quadripolar pacing technology, provided in its 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," Dr Fain said.

"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."

In March 2013, St Jude Medical obtained CE Mark approval for its Allure Quadra CRT-P and the Assurity and Endurity pacemakers.

The company plans to launch these devices in the US by the end of the first quarter this year.


Image: St Jude Medical's allure quadra cardiac resynchronisation therapy pacemaker. Photo: courtesy of Business Wire, St Jude Medical Inc.