BIOTRONIK Wins FDA Approval for Two High-Voltage Families of Cardiac Implants

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BIOTRONIK Wins FDA Approval for Two High-Voltage Families of Cardiac Implants

BIOTRONIK Wins FDA Approval for Two High-Voltage Families of Cardiac Implants


The FDA has given BIOTRONIK Approval to introduce the company’s Acticor and Rivacor lines of High-Voltage Cardiac rhythm implants. They’re designed to treat tachycardia (likely supraventricular tachycardia (SVT) and have been made to be smaller and have a longer battery life. Some of the Implants have a nearly 15 year lifetime, helping to lower the number of replacement procedures.

All of the Implants are 3 Tesla MR-conditional, meaning that patients can undergo most MRI scans as long as certain precautions are taken.

BIOTRONIK touts the shape of the implants, which are supposedly less irritating on tissues. They even gave a name to it: BIOshape. Additionally, there are advanced programming options that include 20 LV pacing vectors and Cardiac resynchronization therapy (CRT) optimization.

“When determining the best treatment plan for each patient, we assess individual needs and select a device system that provides optimal therapy programming with critical diagnostic features,” in a published statement said Dr.*Larry A. Chinitz, a Cardiac electrophysiologist in*New York City. “We are often forced to choose between important features, which could compromise optimal patient care. The Approval of Acticor and Rivacor offers choices to avoid this compromise. Intelligent software built into these devices enables us to assess disease states and respond accordingly with flexibility and customization. These devices offer sophisticated programming and automation as well as longer battery life, smaller size, and greater MRI access (3 Tesla). Our hope is that this will be a significant advance in device therapy and empower us to improve patient care while reducing long-term risk.”

Here’s the whole list of the approved devices: Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX.

Via: BIOTRONIK…

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