First U.S. Commercial Cases Demonstrate New Approach to Transseptal Access

Transseptal access to the left atrium is critical in catheter-based cardiac procedures, where direct visualization and precise positioning are essential. Clinicians also aim to reduce fluoroscopy use and avoid device exchanges that can complicate left-heart workflows. Following 510(k) clearance, early U.S. commercial experience now demonstrates a zero-exchange transseptal puncture device combining echocardiography-visible positioning with radiofrequency-assisted crossing.

Protaryx Medical’s Protaryx Transseptal Puncture Device was used in the first U.S. commercial cases at UC Davis Health in Sacramento, California. Interventional cardiologist Gagan D. Singh, M.D., performed the initial two procedures during left atrial appendage closure and achieved transseptal crossing on the first attempt in both cases. This milestone marks the beginning of U.S. commercial use of the system.

The system features a highly echogenic, extendable, atraumatic EchoTip designed to support direct visualization, septal navigation, and site-specific positioning while reducing reliance on fluoroscopy. It combines echogenic positioning with radiofrequency (RF)-assisted septal crossing and a zero-exchange design intended to streamline the transition from transseptal puncture to left-heart intervention. RF-assisted crossing is performed with a guidewire compatible with commercially available electrosurgical generators. The Protaryx Transseptal Puncture Device received U.S. Food and Drug Administration (FDA) 510(k) clearance in April 2026.

“These first commercial procedures provided an opportunity to evaluate the Protaryx device in routine clinical practice. The device was clearly visible under echocardiography and allowed us to assess the fossa and perform transseptal access without rewiring. We successfully completed both procedures and will continue to evaluate the technology as we gain additional clinical experience,” said Dr. Gagan D. Singh, interventional cardiologist at UC Davis Health.

“Innovation isn’t another version of the same idea. We didn’t build Protaryx to be a me-too device. We built it because we believed transseptal access deserved a fundamentally different approach. These first commercial cases allowed us to see that approach translate from design intent into real-world clinical use. Sometimes true innovation is difficult to appreciate in a drawing or specification; you have to see it in the hands of a physician. We believe Protaryx provides a meaningful difference in how physicians can approach left-heart access,” said David Mester, Chief Executive Officer of Protaryx Medical.

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