Protaryx Medical has received the US Food and Drug Administration (FDA) 510(k) clearance to market its proprietary transseptal puncture device.
The development supports Protaryx Medical’s efforts to advance minimally invasive left-heart procedures and deliver improvements in procedural safety, efficiency, and workflow for cardiac interventions.
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The device is designed to facilitate safe and reproducible left-heart access.
The system offers zero-exchange delivery, incorporating a unique atraumatic design intended to reduce procedural steps and eliminate the need for rewiring during transseptal access.
It features a highly echogenic, extendable positioning probe and a radiofrequency (RF) guidewire compatible with standard electrosurgical generators.
The device provides site-specific puncture capability to optimise access and positioning, aiming to reduce risk associated with suboptimal alignment, procedural complexity, and downstream complications.
Early clinical evaluation in a first-in-human study (n=five) demonstrated procedural success in all cases.
No device-related adverse events were reported, and the study showed minimal crossing time as well as reduced fluoroscopic exposure, providing further evidence of workflow improvement and patient safety.
Protaryx Medical CEO David Mester said: “Receiving FDA 510(k) clearance is a defining moment for Protaryx. 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 US.”
Protaryx co-founder and Johns Hopkins cardiac surgery medicine system chief Dr James Gammie said: “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.”
Protaryx Medical plans to advance commercialisation in the US and expand clinical adoption.
In December 2024, Protaryx Medical completed a first-in-human trial of its transseptal puncture device.
The company’s trial enrolled five patients, and the TSP procedures were conducted using its device at Sanatorio Italiano hospital in Paraguay, following approval from the Research Ethics Committee of the Paraguayan Institute of Social Studies.
