Medtronic Viva, Evera Cardiac Therapy Implants Get FDA Clearance

Medtronic won FDA approval for its Viva cardiac resynchronization therapy with defibrillation (CRT-D) devices and Evera implantable cardioverter-defibrillators (ICD).

The Viva line of CRT-Ds features AdaptivCRT technology that has shown the ability to improve patient response to therapy compared with historic CRT trials. Both devices also include SmartShock technology that limits unnecessary energy delivery, sport a slimmer body over previous generation devices for greater patient comfort, and use Sprint Quattro Secure defibrillator leads.

From Medtronic’s announcement:

“These devices offer patients and physicians advanced systems that can improve patients’ overall quality of life, while reducing the cost burdens of unnecessary hospitalizations,” said Jagmeet P. Singh, M.D., Ph.D., director of the resynchronization and advanced cardiac therapeutics program at Massachusetts General Hospital in Boston. “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(TM) 2.0, the next generation shock reduction algorithm that enables devices to better differentiate between dangerous and harmless heart rhythms, resulting in a 98-percent inappropriate shock free rate at one year.^[14]

“These devices are designed to provide optimal therapy for patients, while providing economic benefits through fewer hospitalizations, fewer inappropriate shocks and increased longevity, which can result in lower healthcare costs,” said David Steinhaus, M.D., 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.”

Flashbacks: Medtronic Viva/Brava CRT-D’s with AdaptivCRT Technology; Medtronic Evera ICD’s With SmartShock 2.0 Coming to Europe

Press release: Medtronic Announces FDA Approval of New Portfolio of Next-Gen Cardiac Resynchronization Therapy Devices, Implantable Cardioverter-Defibrillators