CIRCA Scientific Announces Successful Completion of Limited Market Release for CrossWise™ RF Transseptal Access System and Expands Compatibility to Additional Sheaths

• CrossWise^™ RF Transseptal Access System successfully completes Limited Market Release and is now commercially available nationwide
  
  
• Expanded sheath compatibility—including FARADRIVE^‡ and CARTO VIZIGO^‡—broadens applicability to virtually all procedures involving left-heart access
  
  
• Cannula-guided, zero-exchange system designed to enhance control, reduce procedural steps, and deliver deliberate, confident septal crossing
  
  
• New data presented at HRS 2025 supports performance across a range of challenging anatomical conditions

ENGLEWOOD, Colo., June 26, 2025 /PRNewswire/ -- CIRCA Scientific today announced the successful completion of the Limited Market Release (LMR) for its CrossWise^™ RF Transseptal Access System, a key milestone following FDA clearance in September 2024. As part of the ongoing commercialization effort, CIRCA has also expanded compatibility to include both FARADRIVE^‡ and VIZIGO^‡ sheaths, positioning CrossWise to support nearly all electrophysiology procedures requiring left atrial access.

CrossWise is a zero-exchange RF system that delivers energy through a purpose-built cannula designed to maintain shape and stability during septal crossing. This cannula-guided approach allows for deliberate control and precise positioning, helping to reduce the risk of unintended movement—even in challenging anatomies. With sheath flexibility and a streamlined workflow, CrossWise is uniquely suited to meet the evolving needs of physicians across a broad spectrum of cases.

Bench-top validation presented at HRS 2025 by Dr. Michael Lloyd and Dr. Rand Ibrahim (Emory University) demonstrated clean, controlled punctures through a variety of septal conditions—including thickened and fibrotic tissue—with successful crossing achieved in as little as 290 milliseconds¹. The zero-exchange design eliminates the need for wire or sheath exchanges, supporting procedural efficiency while maintaining cannula positioning at the septum.

"The completion of our Limited Market Release validates the performance and procedural versatility of the CrossWise system," said Lee Geist, CEO of CIRCA Scientific.
"Physicians consistently tell us the cannula-first design delivers a greater sense of control and precision at the septum. With broader sheath compatibility, CrossWise is now positioned to support virtually all procedures that require access to the left side of the heart."

CrossWise will continue to scale commercially across the U.S. in the coming months. CIRCA Scientific remains focused on delivering innovative access technologies that improve procedural confidence, control, and consistency in the hands of physicians.

About CIRCA Scientific
CIRCA Scientific is dedicated to empowering physicians with innovative technologies that offer unprecedented access and control for complex medical interventions. Guided by a CardioCentric^™ approach, we are committed to enhancing procedural success and advancing patient care. For more information on CIRCA Scientific and its portfolio of cardiac solutions, visit www.circascientific.com.

© CIRCA Scientific, Inc., 2025. All rights reserved. CrossWise, CardioCentric, CIRCA Scientific, and the CIRCA Scientific logo are trademarks of CIRCA Scientific, Inc. Patents: www.circascientific.com/patents. CAUTION: Federal law restricts this device to sale by or on the order of a physician. Please consult the Instructions for Use for indications, contraindications, warnings, and precautions.

1 - Ibrahim, R., Hasselwander, C., Lam, S., & Lloyd, M. (2025, May). Validation of a core-less transseptal system using a specialized energized cannula [Conference poster]. Heart Rhythm Society Annual Scientific Sessions, San Diego, CA, United States.

^‡ Indicates a third-party trademark, which is property of its respective owner.

SOURCE CIRCA Scientific, Inc.