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BIOTRONIK gets FDA nod for Edora HF-T QP MR-conditional pacemaker

by Lauren Dubinsky , Senior Reporter
BIOTRONIK announced today that it received FDA approval for its Edora HF-T QP MR-conditional quadripolar cardiac resynchronization therapy pacemaker.

"Patients with heart failure often suffer various comorbidities independent of their cardiovascular condition," Rupa Basu, senior vice president of marketing for corporate accounts and strategy at BIOTRONIK, told HCB News. "Enabling these patients to access critical MR imaging for future diagnosis and treatment is important so that physicians can provide the best patient care beyond the implant."

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At a volume of 15 cubic centimeters, the company claims that it’s the smallest MR-conditional CRT-P available for sale in the U.S. It can also last almost a decade, which reduces the frequency that heart failure patients have to undergo replacement procedures.

"No matter the clinical benefit, the idea of implanting a large device in the body is often daunting for physicians and patients alike," said Basu. "Small devices like Edora HF-T QP can also fit a wider range of patient anatomies, increasing access to CRT-P technology."

Edora HF-T QP features the company’s MRI AutoDetect technology that automatically recognizes when a patient enters an MR field and changes the device programming to MR mode. It improves patient safety by reducing the amount of time the device is in MR mode and fixes logistical programming challenges that physicians and health systems encounter.

"Patients with heart failure often suffer various comorbidities independent of their cardiovascular condition," said Basu. "Enabling these patients to access critical MR imaging for future diagnosis and treatment is important so that physicians can provide the best patient care beyond the implant."

Edora HF-T QP also offers the added benefit of left ventricle pacing during the MR exam, so these patients have a better experience while in the MR environment.

The device is also equipped with BIOTRONIK Home Monitoring, with automatic, daily transmission verification. A 2014 study published in The Lancet found that it reduces deaths from heart failure by more than 50 percent, and research published this year in the European Heart Journal showed it lowered the rate of hospitalization for worsening heart failure by 36 percent.

It includes Heart Failure Monitor Online, which is a summary of nine long-term heart failure statistics, including thoracic impedance. When physicians combine that with daily updates, they can continuously monitor and track patients’ heart failure status.

The BIOTRONIK Home Monitoring system can also perform comprehensive patient monitoring, and makes statistical trends easily available. A study published in the Journal of the American College of Cardiology in 2010 found that this system helps physicians assess individual patient data faster.

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