FDA Nod For Medtronic’s Next-Generation Portfolio of CRT-D And ICD

Medtronic Viva and EveraIn short

Two new devices from the Medtronic ICD/CRT-D stable have gained FDA’s approval. These are the Viva®portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).

Background

Medtronic claims the Viva CRT-D significantly improves response rate to the therapy for many indicated heart failure patients. Comparing its performance with historical trial data the company says Viva demonstratesd 21 percent reduction in overall heart failure hospitalizations within the first year after implant. It backs the data up with the extended argument that economic analysis presented at ISPOR Europe, which translates performance improvements into healthcare cost reduction for both payers and hospital providers compared to CRT-D devices with traditional programming.

The improved response is reportedly a consequence of 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 percent as compared to historical CRT trials.

Furthermore, Medtronic’s industry-leading device longevity is carried through into these new devices which deliver up to a 25-percent increase in battery longevity (up to 11 years) compared to previous devices. Both systems are paired with the reliable Sprint Quattro® Secure lead, the only defibrillator lead with 10 years of proven performance with active monitoring.

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]

Physician comments

“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.”

Company comments

“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.”

Source: Medtronic, Inc.