Technology | Cardiac Resynchronization Therapy Devices (CRT) | June 28, 2016

St. Jude Medical Expands Heart Failure Portfolio with SyncAV CRT Technology

Real-time responsive pacing technology provides physicians another option for managing heart failure patients not responsive to other therapies

St. Jude Medical, CE Mark, SyncAV CRT, MultiPoint Pacing, CardioStim 2016

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

Related Content

Heart Failure Market to Surpass $16 Billion by 2026
News | Heart Failure| September 19, 2017
The heart failure space across the seven key markets of the U.S., France, Germany, Italy, Spain, the U.K. and Japan is...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Technavio Projects 9 Percent Global Growth for Electrophysiology Therapeutic Devices

Image courtesy of Technavio

News | EP Lab| September 11, 2017
September 11, 2017 — According to the latest market study released by Technavio, the global...
Heart Failure Patients, Clinicians Have Differing Perceptions of Risk Level
News | Heart Failure| September 06, 2017
September 6, 2017 — Physicians identified a majority of patients with advanced...
Israeli Hospital Completes First Implant of CORolla Heart Failure Device
News | Heart Failure| September 05, 2017
Rambam Hospital in Haifa, Israel, recently became the first to use the CORolla device from Israeli start-up company...
EMANATE Trial Shows Apixaban Lowers stroke in AF Patients Undergoing Cardioversion.
News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Apixaban lowers the risk of stroke compared to warfarin in anticoagulation-naïve patients with at
CASTLE-AF Study shows Catheter Ablation of Atrial Fibrillation is First-Line Treatment for Heart Failure Patients. Biotronic Ilivia 7 ICD.

The CASTLE-AF Study shows catheter alation of AF can be used effectively to treat heart failure in patients with an implanted ICD.

News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Final results from the CASTLE-AF study show a 38 percent reduction in the composite of all-cause
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD)| August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices

Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices.

Feature | EP Lab| August 29, 2017 | Dave Fornell
August 29, 2017 — The U.S.
Sponsored Content | Videos | Cardiovascular Ultrasound| August 28, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Overlay Init