St. Jude Medical (NYSE:STJ) said its Allure Quadra pacemaker will be the 1st on the U.S. market to offer quadripolar cardiac resynchronization therapy after the FDA granted pre-market approval to the device.
The FDA also granted PMAs for St. Jude’s Assurity and Endurity pacemakers, St. Jude said. The St. Paul, Minn.-based medical device company also said it’s launching a new line of defibrillator leads based on its Durata platform but using its newer Optim insulation.
The Allure Quadra device provides more pacing configurations that standard bipolar pacing, according to a press release, meaning less risk of additional surgeries to adjust lead placement. The Allure line also features enhanced heart failure diagnostics, according to the release, and is equipped to ship data to St. Jude’s Merlin.net patient care network and to patients’ electronic health records. St. Jude said it plans to have the Allure Quadra on the U.S. market by the end of the month.
The Allure Quadra won CE Mark approval in the European Union a year ago.
"St. Jude Medical is the leader in quadripolar pacing technology, 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," group president Dr. Eric Fain said in prepared remarks. "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."
"Adding the clinical benefits of quadripolar technology to pacemakers will expand the benefits of this therapy to patients. These features and additional pacing options will allow me to provide better care to patients diagnosed with heart failure and reduce the need for repeat procedures, especially for those patients who have been historically hard to treat due to tissue damage in their heart," added Dr. Raffaele Corbisiero of the Deborah Heart & Lung Center in Browns Mills, N.J. "This could have economic benefits as well due to fewer readmissions for heart failure-related events."
St. Jude also announced the global launch of its Optisure defibrillation lead, saying the device has regulatory nods in the U.S., European Union, Canada, Australia and Japan. The Optisure lead is based on St. Jude’s next-generation Durata platform, but uses additional Optim lead insulation. The newer design enhances the Optisure lead’s resistance to abrasion without sacrificing flexibility, according to a press release.
"Today’s announcement reinforces our commitment to continuous innovation across our entire cardiac rhythm management portfolio with a particular focus on system reliability," Fain said in a statement. "The Optisure lead builds on the proven track record of our Durata lead and Optim insulation, which is supported by a large body of evidence that will continue to grow through our active post-market registries."