Biotronik touts FDA approval for next-gen heart devices at HRS 2012 | Regulatory Roundup

May 11, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

Biotronik wins FDA aproval for next-gen heart failure devices

Biotronik landed FDA approval for its next-generation series of implantable heart devices, announcing the win at this year’s Heart Rhythm Society conference in Boston yesterday.

The Oregon-based device maker has touted approval for its Lumax 740, which Biotronik says features technology to provide better information to doctors monitoring a patient’s disease progression and includes Smart Detection technology designed to reduce the incidence of inappropriate shocks to the heart.

"In contrast to competitors, Biotronik’s Smart Detection continues to fully function even after a first therapy attempt, which allows the device to provide pain-free therapies without compromising specificity," according to a press release. "The ability to differentiate atrial from ventricular arrhythmias with high specificity reduces the risk for painful inappropriate shocks."

The company won CE Mark approval in the European Union in November 2011 for the Lumax 740 line with ProMRI technology, which it touted as the world’s first and only implantable defibrillator with clearance for use with MRIs.

Unnecessary-shock reduction appears to be the name of the game, with St. Jude Medical (NYSE:STJ) announcing earlier this week that it too landed FDA clearance for a new line of implantable heart devices featuring SecureSense and ShockGuard technology that aims to prevent unneeded therapy.

Medtronic (NYSE:MDT) yesterday unveiled results from a study demonstrating that delaying ICD shock therapy, effectively giving the device more time to diagnose an abnormal heart rhythm, can help reduce unnecessary shocks without increased risk to patients. Read more

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