Medtronic to Launch Two Updated Cardio Portfolios in U.S.

Minneapolis, Minn.-based medical device giant Medtronic Inc. has earned approval from the U.S. Food and Drug Administration (FDA) for its new Viva portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera portfolio of implantable cardioverter defibrillators (ICD). The company also announced the U.S. launch of both.

The Viva CRT-D is intended to improve response rate to the therapy for many indicated heart failure patients, and has reportedly demonstrated a 21 percent reduction in overall heart failure hospitalizations within the first year after implant as compared to historical CRT trials. The device is designed to adapt to individual patient needs and preserve each patient’s normal heart rhythms, which is what purportedly increases response rates. The algorithm is called AdaptivCRT, and is claimed to improve heart failure patients’ response rate to CRT-D therapy by 12 percent as compared to historical CRT trials.

According to economic analyses presented at the International Society for Pharmacoeconomics and Outcomes Research 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 next-generation Viva CRT-D and Evera defibrillation devices feature a new, contoured design that is meant to reduce skin pressure by 30 percent and deliver greater battery longevity. The devices come equipped with the most advanced shock reduction technology available. According to Medtronic, the Viva and Evera systems deliver up to a 25 percent increase in battery longevity (up to 11 years) compared to previous devices. The portfolios include SmartShock 2.0, a shock reduction algorithm designed to enable devices to better differentiate between dangerous and harmless heart rhythms, resulting in a reported 98 percent inappropriate shock free rate at one year.

The Viva and Evera systems are paired with Medtronic’s Sprint Quattro secure leads. Medtronic’s Quattro leads have been the subject of controversy in the past, most notably last year when competitor St. Jude Medical accused them of causing 377 deaths. The accusation came after Medtronic backed a study conducted by Minneapolis Heart Institute Foundation researcher Robert Hauser, M.D., which found St. Jude’s Riata defibrillator leads to have caused 22 patient deaths. While the Riata leads were recalled by the FDA, the Quattro leads were not.

“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, Mass. “Patients can now experience a more comfortable fit due to less skin pressure, a longer lasting battery, and highly advanced CRT-D algorithms.”

“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 of Medtronic’s heart failure unit, 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.”