• Thursday, August 23rd, 2012

Medtronic lands CE Mark approval in the European Union for its Viva/Brava line of defibrillators that adapt to patients’ cardiac rhythms.

Medtronic

Medtronic (NYSE:MDT) said it won CE Mark approval from the European Union for its Viva/Brava line of cardiac rhythm management devices.

The medical device company said the Viva and Brava products, which are cardiac resynchronization therapy with defibrillation devices, feature a new algorithm it calls AdaptivCRT designed to optimize their CRT-D treatment.

The software helped reduce right ventricular pacing by 44%, reducing unnecessary treatment and prolonging the life of the devices, according to a press release.

“The Viva/Brava family of devices offers clinicians and their patients a new approach to CRT treatment, providing therapeutic benefit and individualized care for patients,” CRM president Pat Mackin said in prepared remarks. “AdaptivCRT enables us to deliver CRT differently, allowing for greater efficiency and ensuring maximum treatment response.”

Medtronic said the AdaptivCRT software “met its pre-specified safety and efficacy endpoints of non-inferiority as compared to the gold-standard comprehensive echocardiography-guided biventricular pacing,” data that’s the basis for its pre-market approval application with the FDA, according to the release.

https://www.massdevice.com/news/medtronic-lands-ce-mark-vivabrava

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