Medtronic today announced that it has signed an agreement with Acutus Medical Inc., a manufacturer of arrhythmia management technologies, for exclusive rights to distribute and acquire its left-heart access portfolio. This agreement includes products used to access the left side, or left atrium, of the cardiac anatomy; essential technology needed for the estimated 800,000 transseptal crossings performed annually during electrophysiology (EP) and structural heart procedures. Included in the agreement are the AcQCross® line of sheath-compatible septal crossing devices, the AcQGuide® MINI integrated crossing device and sheath, the AcQGuide® FLEX steerable introducer with integrated transseptal dilator and needle, and the AcQGuide® VUE steerable sheath.

Medtronic will become the exclusive distributor of the AcQCross system and select AcQGuide products by the first half of calendar year 2023. This structure will ensure physician and patient continuity for these critical tools as Acutus and Medtronic work together to transition the assets to Medtronic. After certain transfer conditions are met, Medtronic will take ownership of the products.

“By growing our portfolio with left-heart access tools, we’re able to accelerate our cardiac ablation business strategy as well as bring an advanced transseptal technology to support physicians during a critical component of an ablation or structural heart procedure,” said Rebecca Seidel, president of the Cardiac Ablation Solutions (CAS) business, which is part of the cardiovascular portfolio at Medtronic. “We have the ability to expand our presence in the growing number of catheter-based cardiac procedures to create natural synergies with electrophysiologists and interventional cardiologists – many of whom are using our Medtronic technologies today.”

The AcQCross system brings new innovation to the transseptal access segment and today’s current standard of care. Uniquely engineered to pair with commercially available sheaths, such as the Medtronic FlexCath Steerable® Sheath, the AcQCross system supports the challenging and critical step of accessing the left atrium during EP and structural heart procedures, including AF ablation procedures, left atrial appendage occlusion, and transcatheter mitral valve repair. The first and only transseptal access system on the market cleared for both mechanical and radiofrequency (RF) crossing, the AcQCross system simplifies transseptal crossing for electrophysiologists or interventional cardiologists to improve workflow, add procedure efficiencies, and help alleviate complexity during left heart procedures. 

“Transseptal crossings in left-heart procedures can be complex; and how access to the left-atrium is achieved plays an integral role in the overall success of the procedure,” said Khaldoun Tarakji, M.D., M.P.H., chief medical and safety officer, Cardiac Ablation Solutions. “With the integration of this advanced transseptal access technology into our portfolio, Medtronic has the potential to help optimize physician workflow and overall patient outcomes.”

The AcQCross Qx Integrated Transseptal Dilator/Needle received U.S. Food and Drug Administration clearance in 2021 and CE Mark in 2020.