Medtronic (NYSE:MDT) won FDA approval for its Viva CRT-P cardiac resynchronization therapy-pacemaker, which features proprietary software to adjust its pacing parameters to a patient’s heart rhythms minute-by-minute.
The win comes just weeks after the FDA approved the Viva Quad XT CRT-D cardiac resynchronization therapy defibrillators. The devices are part of the larger Viva and Brava suites of cardiac rhythm management devices which feature the AdaptivCRT programming, which Medtronic called "the only algorithm demonstrated to improve heart failure patients’ response to the therapy and reduce the risk of atrial fibrillation."
"Our aim is to help people living with heart failure by making cardiac resynchronization therapy even better, through research and improved therapies," Medtronic cardiac rhythm & heart failure management division medical director Dr. David Steinhaus said in prepared remarks. "The addition of Viva CRT-P to our U.S. portfolio reinforces our commitment to making CRT treatment even more powerful by improving care for patients, reducing complications and ultimately reducing costs."
The Viva pacemaker has been available in Europe since winning approval in May this year..
The devices also contain diagnostic features, such as fluid status monitoring, which may help doctors identify at-risk patients.
MDT shares were trading relatively flat this morning, up 0.5% to $63.88 as of about 11:45 a.m. The stock has gained 11.3% since the start of the year.