June 28, 2016 — St. Jude Medical Inc. announced CE Mark approval and launch of SyncAV CRT software, designed to build upon the company’s MultiPoint Pacing technology and further optimize its comprehensive cardiac resynchronization therapy (CRT) portfolio.
MultiPoint Pacing technology with the SyncAV CRT software algorithm is designed to address and effectively treat heart failure patients who are not responsive to other pacing options. The SyncAV technology, which automatically adjusts pacing based on real-time changes in a patient’s cardiac condition, also provides physicians the opportunity to further improve treatment of patients who have responded positively to traditional CRT.
In addition to the approval of SyncAV CRT software, the company has also received CE Mark approval for the Quadra Assura MP CRT-Defibrillator (CRT-D) with full-body magnetic resonance (MR) labeling. With the updated labeling, patients will have unrestricted access to MRI diagnostic testing. Approvals of the SyncAV CRT software and Quadra Assura MP CRT-D with full-body MRI support the continued rollout of MultiPoint Pacing technology throughout Europe.
“Although we have made substantial improvements in how we treat heart failure patients, there are still certain patients who are not getting the outcomes with traditional CRT that we would like to see. The SyncAV CRT algorithm dynamically individualizes programming to work towards providing patients with the right settings at the right time helping offer the best possible outcome for even our most complex patients,” said Timothy Betts, M.D., consultant cardiologist and electrophysiologist at the Oxford Heart Centre in the John Radcliffe Hospital. “Our goal is to utilize the technology to improve outcomes while offering patients who do not respond to therapy with additional options for treatment.”
For patients suffering from heart failure, CRT technology resynchronizes the lower chambers (ventricles) of the heart by sending uniquely programmed electrical impulses to stimulate each ventricle to beat in sync to offer the best cardiac performance.
The MultiPoint Pacing technology, featured on the Quadra Assura MP CRT-D and the Quadra Allure MP CRT-P, including SyncAV CRT technology, as well as the Quadra Assura MP CRT-D with full-body MRI were all showcased at the CardioStim-EHRA Europace 2016 annual conference. In addition, the investigational device exemption (IDE) clinical study results for the MultiPoint Pacing technology were presented during a late-breaking clinical trial session at the congress. The MPP IDE study met its primary endpoints of safety and efficacy, and additional analyses indicated a positive impact of MultiPoint Pacing programming on patient response to therapy.
An Italian registry on multipoint left-ventricular pacing in CRT (IRON-MPP) was presented at the congress and also published in Europace. Author and presenter of the data, Giovanni Forleo, M.D., electrophysiologist at the University Hospital of Tor Vergata, Rome, Italy, said, “Our goal with this study was to help build a large body of clinical evidence to inform clinical decision-making standards for the management of heart failure patients implanted with MultiPoint Pacing capable CRT-D devices. The results of this study show that establishing optimal programming with the MultiPoint Pacing technology can realize a maximized benefit for patients.”
CRT includes a lead (Quartet Quadripolar LV Lead) placed on the left ventricle. The left ventricle pumps oxygenated blood from the heart out to the rest of the body. MultiPoint Pacing technology is designed to deliver independent electrical pulses to multiple locations on the Quartet lead to make the heart’s lower chambers pump in a more coordinated way to mirror the natural contractions of a healthy heart.
The St. Jude Medical MORE CRT MPP clinical study is designed to demonstrate the benefits of the St. Jude Medical MultiPoint Pacing technology in improving patient response to CRT therapy.
For more information: www.sjm.com