Biotronik secures FDA approval for cutting-edge heart rhythm management devices

Biotronik, a German biomedical technology company, has received approval from the US Food and Drug Administration (FDA) for its high-voltage cardiac rhythm management (CRM) devices. These include the Acticor and Rivacor series, which are designed to treat heart arrhythmias, such as atrial fibrillation, and offer a range of innovative solutions for patients and healthcare providers alike.

The FDA’s green light applies to six advanced devices in the Acticor and Rivacor line, specifically the Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX, and Acticor CRT-DX Bipolar. Biotronik is planning to roll out these new systems in the US by April 2019, marking a significant milestone in the company’s mission to provide cutting-edge cardiac care solutions.

Advanced Technology Meets Compact Design: A Step Forward in Patient Care

The newly FDA-approved devices are equipped with advanced diagnostic and therapeutic capabilities that make them smaller, more efficient, and capable of delivering extended battery longevity. According to Biotronik, these systems are designed not only to treat patients with various cardiac conditions but also to provide physicians with more comprehensive therapeutic options, especially when managing patients with complex disease states and comorbidities.

The Acticor and Rivacor devices are touted as the smallest and slimmest 3 Tesla MR-conditional CRM devices currently available on the market. They feature Biotronik’s patented smooth elliptical BIOshape, which enhances patient comfort by reducing skin pressure and minimizing the chances of skin erosion, a common issue with bulkier devices. Their slim and rounded edges ensure that patients experience less discomfort, making them a preferred option for long-term use.

Extended Battery Life Means Fewer Replacements, Lower Risks

One of the standout features of the Acticor and Rivacor systems is their extended battery life. Biotronik claims this improvement means fewer device replacements for patients, which in turn reduces the frequency of procedures, lowering the associated risks, complications, and overall healthcare costs.

The Acticor family, in particular, integrates the company’s innovative DX technology, which allows for atrial diagnostics without the need for an atrial lead. This feature helps in the early detection of silent atrial fibrillation, which is crucial for stroke prevention. Additionally, it offers improved diagnostic accuracy for better clinical decision-making and can discriminate between dual-chamber supraventricular tachycardia (SVT) to eliminate unnecessary shocks, providing a more tailored and effective treatment experience for patients.

Revolutionizing Cardiac Treatment with Intelligent CRT Programming

Biotronik has also introduced the Rivacor HF-T QP, which is described as providing more flexibility than any other existing cardiac resynchronization therapy (CRT) device system. The intelligent CRT AutoAdapt programming adjusts automatically to changes in the patient’s condition, ensuring real-time, responsive care that saves time for physicians and hospital staff. This adaptive technology marks a significant leap forward in patient management, allowing for more precise interventions with less manual input.

Expert Insight: A Leap Forward for Cardiac Care

Ryan Walters, President of Biotronik, emphasized the significance of these innovations: “Simplifying care through exceptional diagnostics and automated therapy is another example of how Biotronik continues to help physicians provide unmatched patient care. The Acticor and Rivacor device systems reflect our commitment to engineering solutions with profound positive impacts for patients, physicians, and health systems alike.”

He added, “We remain focused on bringing cardiac solutions to the US market that streamline processes and improve the ability to deliver care without compromise. There isn’t anything on the market that compares to Acticor and Rivacor.”