Protaryx Medical Receives FDA 510(k) Clearance for Its Breakthrough Transseptal Puncture Device

BALTIMORE--(BUSINESS WIRE)--Protaryx Medical, an innovative medical device company developing disruptive access solutions for minimally invasive left-heart procedures, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the proprietary Transseptal Puncture Device.

This milestone represents a significant advancement in the Company’s mission to redefine safe, efficient, and reproducible left heart access for cardiac interventions, enabling broader adoption and improved delivery of minimally invasive therapies.

Key Highlights

• The system is designed to support zero-exchange delivery and features a unique atraumatic design that reduces procedural steps and the need for rewiring, resulting in improved workflow efficiency.
• The device incorporates a highly echogenic, extendable atraumatic positioning probe and a standardized RF guidewire compatible with commercially available electrosurgical generators.
• Enables precise, site-specific transseptal puncture (TSP) to optimize access and positioning for cardiac interventions, reducing the risk of suboptimal device alignment, procedural complexity, and downstream clinical complications.
• In an early First-in-Human study (n=5), the device demonstrated procedural success in all cases with no reported device-related adverse events, minimal crossing time, and reduced fluoroscopic exposure.

Company Commentary
“Receiving FDA 510(k) clearance is a defining moment for Protaryx,” said David Mester, Chief Executive Officer of Protaryx Medical. “This achievement reflects the dedication of our team to solving one of the most critical challenges in safe and efficient transseptal access procedures. We are now positioned to bring this transformative technology to physicians and patients across the United States.”

Protaryx co-founder and System Chief of Cardiac Surgery at Johns Hopkins medicine, Dr. James Gammie, added: “This clearance underscores the strength of the technology and its potential to set a new standard for transseptal puncture. By simplifying access to the left atrium, the device can expand procedural adoption while improving safety, precision, and ease-of-use.”

Interventional cardiologist Dr. Gagan Singh (UC Davis Health), who participated in the FIH study, previously noted the device’s “superior echogenicity, atraumatic design, and ease of use,” highlighting its ability to reduce the learning curve and enable more targeted, efficient procedures.

Technology Overview
The Protaryx Transseptal Puncture Device is a next-generation solution designed to streamline access to the left side of the heart. The system enables zero-exchange catheter procedures and integrates proprietary RF guidewire technology with standard electrosurgical generators. Its highly echogenic, extendable atraumatic probe enhances visualization and positioning, delivering improved workflow efficiency, precision, and safety for operators of all experience levels.

With FDA clearance secured, Protaryx Medical plans to initiate U.S. commercialization and expand clinical adoption, supporting physicians in delivering advanced cardiac therapies.

About Protaryx Medical
Protaryx Medical is a Baltimore-based medical device company dedicated to enhancing access and procedural efficiency cardiac interventions. The Company’s innovative Transseptal Puncture Device delivers groundbreaking advancements in left-atrial access, simplifying procedures while optimizing workflow and patient outcomes.

For more information, please visit www.Protaryx.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding commercialization plans and market adoption. Actual results may differ materially from those projected. The Company undertakes no obligation to update forward-looking statements.