BIOTRONIK and CardioFocus Announce Strategic Partnership for Exclusive Distribution of Centauri PFA System in Europe

BIOTRONIK Announces Strategic Distribution Agreement with CardioFocus. BIOTRONIK will obtainCardioFocusIn Europe (Selected Countries)Exclusive Distribution Rights for the Centauri Pulse Field Ablation (PFA) System.

Executive Evaluation

"We are honored to partner with CardioFocus to expand the reach of the Centauri system in key European markets. As pulsed field ablation technology advances, hospitals increasingly require solutions that offer both superior clinical performance and operational flexibility. This collaboration underscores our steadfast commitment to advancing electrophysiology innovation and supporting physicians in improving patient outcomes."

---Andreas Hecker  President of BIOTRONIK Cardiac Rhythm Management and Electrophysiology Business

"We are thrilled to partner with a well-established and clinically trusted company like BIOTRONIK to bring our technology to more patients and healthcare providers across Europe. BIOTRONIK’s deep expertise in electrophysiology, extensive global presence, and commitment to physician training make it the ideal partner to support Centauri’s next phase of growth."

---Steve Ogilvie  CEO of CardioFocus

Centauri is globalThe second PFA product to be launched received CE approval in 2022 and was approved in China in 2024.CardioFocus Acquisition. The product has been on the market for over three years, but its commercial progress has not been smooth (only completing more than 8,000 surgeries). The reason is that this product only has a platform capability without a dedicated matching catheter. Now, with the cooperation with BIOTRONIK, it will be an important milestone for Centauri's commercial expansion.

Of course, CentauriAs a new generation of focal pulsed field ablation system, it also has its unique features, which are the ability to be compatible with various radiofrequency ablation catheters and widely used mapping systems, as well as flexible workflow integration capabilities.

ForFor BIOTRONIK, this is the first reinforcement around its future three core businesses after selling its vascular intervention business. In the highly competitive electrophysiology field, it keeps up with the pace of the four giants.

CENTAURIAt the beginning of this yearCardioFocusAcquired from Galvanize Therapeutics.CENTAURIIt is the second commercially available PFA product globally and received CE approval for market launch in 2022.

CENTAURIUnlike the vast majority of PFA products on the market, it only has an energy platform and no ablation catheter of its own.CardioFocusPromoted as an open electropulse energy platform, it can currently be used in conjunction with ablation catheters and 3D mapping systems from Johnson & Johnson, Abbott, and Boston Scientific.

CENTAURIUsing a unipolar biphasic waveform, it can achieve transmural lesions while eliminating microbubbles and muscle stimulation when used in conjunction with other commercially available pressure ablation catheters.CENTAURIWith three energy intensity outputs: 19, 22, and 25A, allowing for the selection of energy intensity based on the lesion.

The following figure shows the ablation depth of 19A energy intensity. The reason for such depth is due toIn unipolar, an electric field pointing towards the remote dispersion electrode is generated at the catheter tip. Unipolar PFA achieves deeper lesions than equivalent bipolar configurations.

CENTAURI Advantage

• Wave1

CardioFocus's proprietary waveform is specifically customized for traditional endocardial ablation procedures, balancing full-thickness tissue ablation while limiting the impact on extracardiac structures.

• Adjustable Energy Level

• Zero Bubble

• Auto impedance

• Current Control

The Centauri current control algorithm ensures consistent current output for all patients' catheters, thereby ensuring predictable lesion size.