BIOTRONIK Receives FDA Approval for Six Tachycardia Devices

BIOTRONIK Tachycardia device

Cardiac patients have varying conditions, so physicians need more comprehensive therapy options when treating these patients. BIOTRONIK, a Berlin, Germany-based biomedical technology company, just received FDA approval for six new tachycardia solutions: Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX. These high-voltage cardiac rhythm management (CRM) devices are aimed at treating patients with cardiac arrhythmias.

Read more TAGecg 7-Day Wearable ECG Sensor: A Smarter, Simpler Path to Cardiac Diagnostics

The Acticor and Rivacor systems incorporate more diagnostic and therapeutic capabilities in smaller devices with extended battery life, providing physicians with a broader treatment options for dealing with cardiac patients with varied conditions, said a press release.

The Acticor family offers BIOTRONIK’s proven DX technology, which provides atrial diagnostics without an atrial lead. Programming options in the Rivacor HF-T QP include 20 LV pacing vectors and cardiac resynchronization therapy (CRT) optimization, making them more flexible than any other CRT device system on the market.

These devices are the smallest and slimmest 3 Tesla (3T) MR-conditional CRM devices on the market. The rounded edges on these devices lessen skin pressure and help to lower the risk of skin erosion while increasing patient comfort.

BIOTRONIK

Because of the extended longevity these devices (nearly 15 years for VR-T, 13.5 years for DR-T, 14 years for DX and nine years for CRT), they need fewer replacements, thereby reducing risks, complications and costs. Acticor and Rivacor are backed by extended warranties, giving health systems confidence when partnering with BIOTRONIK.

Read more Cardiologists Use Augmented Reality to Plan and Perform Complex Procedures

“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,” 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,” he added.