Protaryx Medical, an innovative medical device company developing disruptive access solutions for minimally invasive left-heart procedures, announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its proprietary Transseptal Puncture Device.

This submission marks a major milestone in the Company’s mission to redefine safe, efficient and reproducible left-atrium access for structural heart interventions.

Key Highlights

• The Protaryx Transseptal Puncture Device is designed to provide zero-exchange delivery of left-atrial therapy devices, improving workflow efficiency.
• The technology features a highly echogenic, extendable atraumatic positioning probe combined with a standardized RF guidewire compatible with commercially available electrosurgical generators, enabling enhanced visualization, precision and operator ease-of-use.
• The Company’s first-in-human (FIH) study, conducted on December 3, 2024, in Asunción, Paraguay (five patients), achieved all procedural success endpoints, no adverse events, substantially reduced fluoroscopic exposure and rapid patient discharge.
• With the 510(k) submission, Protaryx is now advancing toward U.S. regulatory clearance and the commercial launch of its device, opening a pathway to broaden access to left-heart therapies and improve patient care.

Company Commentary

“Achieving 510(k) submission is a pivotal milestone for Protaryx,” said David Mester, Chief Executive Officer of Protaryx. “Our team has worked with laser focus to solve one of the core workflow and ease-of-use challenges in structural heart procedures: transseptal puncture and left-atrial access. This submission brings us one step closer to offering a solution that enables physicians of all experience levels to operate with greater precision, less fluoroscopy, and a faster learning curve.”

Protaryx co-founder and System Chief of Cardiac Surgery at Johns Hopkins Health System, Dr. James Gammie added: “The results from the FIH study show that this device not only meets unmet needs in transseptal access but has the potential to set a new standard for safety, ease-of-use, and efficiency in left-heart interventions.”