FDA gives green light for smallest, slimmest 3T CRM devices

FDA gives green light for smallest, slimmest 3T CRM devices

by John R. Fischer, Senior Reporter | March 20, 2019
Cardiology
Acticor and Rivacor CRM systems
The FDA has given BIOTRONIK the green light to commence distribution of its Acticor and Rivacor high-voltage cardiac rhythm management (CRM) device families.

The six new solutions are the smallest, slimmest 3 Tesla Tachycardia devices to receive FDA clearance, according to BIOTRONIK, and are equipped with more diagnostic and therapeutic capabilities in comparison to other CRM devices, as well as extended battery lives. They are Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX.

“Historically, the size of CRM devices has been driven by battery longevity – increased longevity required larger devices,” Rupa Basu, senior vice president of marketing for corporate accounts and strategy at BIOTRONIK, told HCB News. “With the launch of the Acticor and Rivacor systems, physicians and patients now have access to smaller and thinner CRM devices designed with rounded edges that lessen the pressure on skin, further improving the patient experience without compromising longevity.”

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The ultra slim design of each takes the form of a smooth, elliptical BIOshape, with rounded edges that lessen skin pressure and help lower risk of skin erosion to make patients more comfortable. The greater battery lives reduce the number of device replacements required, along with the number of procedures for patients, and their associated risks, complications and costs.

The Acticor family is equipped with BIOTRONIK’s DX technology, which offers atrial diagnostics without an atrial lead. The reduction in leads enables faster procedure times, and reduces costs and complications. DX systems also detect silent atrial fibrillation for stroke prevention, enhance diagnostic accuracy for better clinical decision-making and prevent unnecessary shocks with the use of dual-chamber supraventricular tachycardia (SVT) discrimination.

Rivacor HF-T QP offers greater flexibility than other CRT devices on the market due to its programming composition which includes 20 LV pacing vectors and cardiac resynchronization therapy optimization. The intelligent CRT AutoAdapt programming enables real-time responsive care by automatically adjusting itself to changes in a patient’s condition, saving time for physicians and hospitals.

In addition, both systems offer BIOTRONIK Home Monitoring, reducing all-cause mortality due to heart failure by more than 60 percent and hospitalization for worsening heart failure by 36 percent; as well as MRI AutoDetect technology, which automatically recognizes and adjusts therapy for the duration of scans when a patient enters an MR environment.

"The Acticor and Rivacor systems offer greater functionality, extended battery life and smaller size than previous devices commercialized by BIOTRONIK," said Basu. "This evolution is a demonstration of our constant commitment to developing sophisticated, innovative devices that enable the best possible patient care. With exceptional programming capabilities, diagnostics, automated therapy, smaller size and thinner design, combined with BIOTRONIK Home Monitoring – the Acticor and Rivacor devices are truly exceptional."

Rivacor VR-T devices can last for nearly 15 years, compared to 13.5 years for Rivacor DR-T; 14 years for Acticor DX and nine for Acticor CRT-DX Bipolar and Acticor CRT-DX.

The solutions are backed by extended warranties and are expected to be available in the U.S. starting in April.

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