Medtronic wins FDA nods for next-gen cardiac devices

Medtronic won FDA approval for Viva, left, and Evera.--Courtesy of Medtronic

Medtronic ($MDT) is padding its fleet of U.S.-approved cardiac devices, winning the FDA's blessing to market new Viva and Evera implants.

Viva, a cardiac resynchronization therapy device, is designed to improve the lives of heart failure patients, boasting a 21% reduction in first-year hospitalizations compared to competing technologies, Medtronic said. That results in not only a safer device but also cost savings for payers and providers, according to the company.

Evera, on the other hand, is an implantable cardioverter-defibrillator outfitted with Medtronic's SmartShock technology, delivering a 98% inappropriate-shock-free rate after one year, the company said. Both devices have been redesigned with contours that reduce patient skin pressure by 30%, according to Medtronic.

"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," Medtronic's Cardiac Rhythm Disease Management Medical Director David Steinhaus said in a statement. "Patients suffering from debilitating heart rhythm disorders can rely on new treatment options that can significantly improve their quality of life."

The new devices are part of Medtronic's efforts to reverse its fortunes in cardiac rhythm management, a business that declined 2% last quarter to $1.2 billion in sales and slipped about 3.3% to $4.6 billion last year. Medtronic is counting on new product rollouts to outweigh the flattening markets for CRT-Ds and ICDs, all while expanding the reach of its growing atrial fibrillation business.

- read the announcement

Special Report: Devicemakers plot paths out of CRM funk

Sponsored By Metabolon

Five Translational Insights Key to a Successful First-in-Human (FIH) Study – Metabolite-Based Biomarker Discovery and Validation

Translational success rates from pre-clinical animal studies to human clinical trials remain frustratingly low. Learn how metabolomics helps you bridge between the theoretical & practical, between the function & actual activity of your drug molecule to get you closer to the phenotype, sooner.