St. Jude Launches New EnSite Precision Cardiac Mapping System in 9 European Countries

St. Jude announced expansion of its EnSite Precision™ cardiac mapping system limited market release in Europe and use of the new platform in more than 600 cases in nine countries since receiving CE Mark in January 2016. The mapping system is a next-generation platform designed to provide automation, flexibility and precision for tailored treatment in patients with cardiac arrhythmias. The launch constitutes introduction of an entirely new suite of technologies including innovations in hardware, catheters, surface electrodes (patches) and software features designed for improved ease of use. The system is currently available and expanding in select European countries as part of its initial launch and the company is currently pursuing U.S. Food and Drug Administration (FDA) clearance of the EnSite Precision cardiac mapping system.

The EnSite Precision cardiac mapping system is used in ablation procedures to visualize and navigate catheters in the heart. The system provides highly detailed anatomical models and maps to enable diagnosis of a wide range of arrhythmias, guide therapy and provide expanded procedural options to tailor care for patients. During this initial launch, the EnSite Precision cardiac mapping system was used in a variety of procedures, from simple to complex, including atypical flutter, paroxysmal and persistent atrial fibrillation (AF), and ventricular tachycardia (VT), with excellent system performance through challenging procedure dynamics.

The EnSite Precision cardiac mapping system uses intelligent automation tools to enable faster, more accurate high-density maps with greater consistency across cases. The system is flexible and enhances efficiency by allowing physicians to map heart chambers with any electrophysiology catheter and customize procedures to address the circumstances of each case. The EnSite Precision cardiac mapping system allows catheter navigation to occur with less fluoroscopy, thus reducing potential for risks associated with excessive radiation exposure.

New release from St. Jude can be found from their website by clicking here.

FDA Approved CardioFocus’ HeartLight® System for Atrial Fibrillation Treatment

CardioFocus, Inc. premarket approval (PMA) from FDA for its HeartLight® Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation (AF).

The device consists of a compliant balloon at the distal end and an optical fiber that can deliver laser energy into the heart. A separate lumen is used to position device that lets the physician visualize the area under the laser gun.

The HeartLight System differs from other AF solutions that rely on x-ray or mapping support for guidance, by allowing the electrophysiologist to control the delivery of therapeutic laser energy, for the first time under direct visual guidance, to electrically and durably isolate the pulmonary veins (PVs).

More info available from Cardio Focus Inc. website.

St. Jude CardioMEMS HF System Could Reduce Hospitalizations

St. Jude today announced a new analysis published in the Journal of the American College of Cardiology: Heart Failure shows pulmonary artery (PA) pressure monitoring with the St. Jude Medical™ CardioMEMS™ HF System can improve medical management and prevent hospitalizations of heart failure patients as compared to the traditional standard of care (weight and blood pressure tracking). The study supports the use of PA pressure monitoring to help clinicians proactively identify the early onset of worsening heart failure and to adjust therapeutic interventions in order to decrease the risk that patients will be hospitalized for congestive heart failure.

In patients suffering from chronic heart failure, the heart cannot adequately pump blood to meet the body’s demands. As heart failure worsens, increased pressures can develop in the heart and pulmonary arteries, which previous research has shown to adversely affect patients’ health and increase the risk of hospitalization.A new analysis of data from the CHAMPION study found that actively monitoring patients with the CardioMEMS HF System was more effective in reducing heart failure hospitalizations than conventional medical management.

The CardioMEMS HF System is the first and only FDA-approved heart failure monitor that, when used by physicians, has been shown to significantly reduce heart failure hospital admissions and improve the quality of life in New York Heart Association (NYHA) Class III patients. Long-term, prospective data published in The Lancet supports the effectiveness of the CardioMEMS HF System at reducing heart failure hospitalizations by demonstrating the system can provide physicians the opportunity to proactively manage their heart failure patients.

The CHAMPION trial originally demonstrated a statistically and clinically significant 28 percent reduction in the rate of HF hospitalizations at six months, and a 37 percent reduction in HF hospitalizations during an average follow-up duration of 15 months.

More information could be found from St. Jude Website by clicking this link.

3-in-1 Cardiac Arrhythmias Remote Monitoring System gets FDA Clearance

InfoBionic, Inc. announced that it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for MoMe® Kardia, a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac Monitoring.

MoMe® Kardia is the first 3-in-1 single piece device that acquires and stores ECG and motion data and transmits that data via embedded cellular technology to the MoMe® Software System, a cloud-based platform with proprietary algorithms for analysis, using the MoMe® Device Communications Protocol. The transmitted data is then analyzed by the MoMe® Software Platform via completely new and robust server-based algorithms and when indicated, data identified by these algorithms is flagged for physician review. MoMe® Kardia requires no patient intervention to capture or analyze data, however it does provide a patient event trigger.

InfoBionic news release could be found from this link.

St. Jude obtains CE approval for MRI Compatible Nanostim Leadless Pacemaker

St. Jude announced CE Mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for the company’s Nanostim™ leadless pacemaker. With the approval, throughout Europe both existing patients implanted with a Nanostim leadless pacemaker and new patients receiving a Nanostim leadless pacemaker in the future can safely undergo full-body MRI diagnostic scans.

Product information could be found from this link.

Further news: FDA Approves World’s Smallest yet Leadless Pacemaker