SJM Gets 3 New FDA Pacemaker Approvals

St. Jude Medical seems to be doing its best to corner the pacemaker market, announcing FDA approvals for three new pacemakers.

Executives at the Little Canada, MN-based company intend to launch the new pacemakers in the United States by the end of the first quarter.

The company's Allure Quadra, Assurity, and Endurity lines, all three of which received the CE marking a year ago, can now be implanted in the United States. SJM says the Allure Quadra is the first device to bring quadripolar lead technology to the U.S. pacemaker market.

"St. Jude Medical is the leader in quadripolar pacing technology, (which we have) 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," Eric S. Fain, MD, group president at SJM, said in a news release.

This quadripolar technology provides the added versatility to allow for additional pacing configurations within the heart. It offers physicians options not available in traditional bipolar systems, helping them manage common pacing complications without exposing the patient to additional surgeries for lead repositioning. SJM says that more than 100 clinical publications to date have provided broad clinical evidence in support of the advantages of quadripolar technology.

Additional cutting-edge features of the Allure family of devices include enhanced heart failure diagnostics that can help with patient monitoring and offer insights into disease progression and management. St. Jude Medical says that device information from the Allure Quadra CRT-P is automatically transmitted to their secure Merlin.net Patient Care Network website, as well as to the patient's electronic health record where the information can be viewed by medical professionals.

But not all pacemaker candidates need these advanced capabilities. For those with less complex needs, SJM has also introduced their Assurity and Endurity pacemaker families, which also feature the company's most up-to-date technology.

The Assurity and Endurity pacemakers are designed for longevity and feature a smaller size. The devices offer early notification of atrial fibrillation-related events and pacing that is said to help reduce hospitalizations. Both models are available as a single or dual chamber pacemaker (pacing either one or both chambers of the heart) and are said to provide a higher level of care at implant and throughout the patient's life.

The Assurity pacemaker uses radio-frequency technology to automatically transmit device data to a physician or care team without any action by the patient. The Endurity pacemaker uses inductive telemetry to rapidly provide device data during interrogation. Both pacemakers are supported by SJM's Merlin.net Patient Care Network website for remote patient management. 

Stephen Levy is a contributor to Qmed and MPMN.