FDA approves Viva CRT-D and Evera ICDs


On 6 May, Medtronic announced the FDA approval and US launch of its newest cardiac devices: the Viva portfolio of cardiac resynchronisation therapy with defibrillation (CRT-D) devices, and the Evera portfolio of implantable cardioverter-defibrillators (ICD).

According to a company release, the Viva CRT-D significantly improves response rate to the therapy for many indicated heart failure patients, with a demonstrated 21% reduction in overall heart failure hospitalisations within the first year after implant as compared to historical CRT trials. According to economic analyses presented at ISPOR Europe, with this device both payers and hospital providers will experience reductions in overall healthcare costs as compared to CRT-D devices with traditional programming.

The improved response is due to the device’s ability to continuously adapt to individual patient needs and preserve each patient’s normal heart rhythms. Called AdaptivCRT, the algorithm improves heart failure patients’ response rate to CRT-D therapy by 12% as compared to historical CRT trials.

The release also states that the next-gen Viva CRT-D and Evera defibrillation devices are shaped for patient comfort with a new, contoured design that reduces skin pressure by 30%,deliver greater battery longevity and come equipped with the most advanced shock reduction technology available.

“These devices offer patients and physicians advanced systems that can improve patients’ overall quality of life, while reducing the cost burdens of unnecessary hospitalisations,” said Jagmeet P Singh, director of the resynchronisation and advanced cardiac therapeutics program at Massachusetts General Hospital in Boston, USA. “Patients can now experience a more comfortable fit due to less skin pressure, a longer lasting battery, and highly advanced CRT-D algorithms.”

The Viva and Evera portfolios include SmartShock 2.0, the next generation shock reduction algorithm that enables devices to better differentiate between dangerous and harmless heart rhythms, resulting in a 98% inappropriate shock free rate at one year.

“These devices are designed to provide optimal therapy for patients, while providing economic benefits through fewer hospitalisations, fewer inappropriate shocks and increased longevity, which can result in lower healthcare costs,” said David Steinhaus, vice president and general manager, Heart Failure, and medical director for the Cardiac Rhythm Disease Management business at Medtronic. “Patients suffering from debilitating heart rhythm disorders can rely on new treatment options that can significantly improve their quality of life.”