St. Jude Medical Announces the European Launch of the Trifecta Surgical Valve with Glide Technology

St. Jude announced the European launch of the company’s most advanced tissue valve — the Trifecta™ valve with Glide™ Technology (GT) — for the treatment of diseased, damaged or malfunctioning aortic heart valves, which control blood flow from the heart to the rest of the body. Tissue aortic valve replacement can improve quality of life for patients suffering heart failure or aortic regurgitation, ease symptoms and help patients live longer lives. For physicians, the new Trifecta™ GT tissue valve offers enhanced valve delivery to ease implantation in challenging anatomies and surgical approaches combined with the proven best-in-class hemodynamic excellence of the Trifecta™ valve.

The first Trifecta GT valve was implanted by Dr. Gebrine El Khoury, of St-Luc Hospital in Brussels, Belgium. Dr. El Khoury has extensive experience with the original Trifecta tissue valve and commented that the new Trifecta GT tissue valve, “will help us provide the best care possible for our patients in need of aortic valve replacement and especially those with challenging clinical cases.”

The new Trifecta GT valve builds on St. Jude Medical’s decades-long legacy of designing and developing mechanical and tissue heart valves for patients in need of options to replace their damaged or diseased native heart valves. The original Trifecta valve provided patients a tissue valve that was proven to function in the same way as their native aortic valve. Now, the Trifecta GT tissue valve has improved upon the original, and provides physicians a tissue valve option that is easier to implant but that retains its optimal hemodynamic (circulatory) performance.

Linx™ AC Treatment, an anticalcification treatment designed to reduce tissue mineralization (hardening). The valve’s fatigue-resistant titanium stent provides a supportive frame within a patient’s heart for added durability.

The Trifecta GT tissue valve received CE Mark approval in February 2016, further expanding the St. Jude Medical valve product portfolio, which includes market-leading mechanical heart valves, aortic and mitral tissue valves, valve repair annuloplasty rings and the Portico™ TAVR valve available currently in Europe.

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St. Jude Announces CE Approval of Quadripolar Pacing Leads

St. Jude announced CE Mark approval and launch of three new Quartet™ left ventricular (LV) leads, offering additional electrode spacing options and one new lead shape. The additional spacing combinations are aimed to more effectively target the individual cardiac anatomies of patients who need support from cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D).

Studies have shown that CRT can improve the quality of life for many patients with heart failure. CRT resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. The addition of MultiPoint Pacing™ technology enables physicians to program a single Quartet LV lead to pace multiple sites on the left side of the heart, giving the clinician more choices to improve patient response to therapy and reducing the likelihood of costly and invasive lead revision through a second intervention procedure.

The newly-approved additional quadripolar lead options are used with next-generation MultiPoint Pacing technology, which enables physicians to pace multiple locations on the left side of the heart and provide physicians a new option for patients who haven’t responded to CRT. The expanded selection of quadripolar pacing leads makes the St. Jude Medical quadripolar lead portfolio the broadest on the market and allows for enhanced individualization of CRT. The new leads are designed based on the company’s first-to-market proven quadripolar LV lead technology and include additional spacing options on two new S-shape and one new double-bend lead designs.

Some of the newly approved products are also magnetic resonance (MR) – conditional, including the Quadra Assura™ CRT-D and Quadra Assura MP™ CRT-D with MultiPoint™ Pacing. Additionally, physicians will be able to quickly customize therapy using the Auto VectSelect Quartet™ Test, which is designed to automatically guide programming of the most appropriate therapy options available and streamline workflow.

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.

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