News and analysis on medical technology
FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Protaryx Transseptal Puncture Device for Left-Heart Access

The Baltimore startup's single-use device combines a sheath, dilator and radiofrequency guidewire for crossing the wall between the heart's upper chambers.

By News DeskApril 13, 20262 min read
A hospital cardiac catheterization laboratory
A cardiac catheterization lab used for angiograms and angioplasty. Not a procedure using the Protaryx device described in this article. Hmhedp, CC BY-SA 3.0, via Wikimedia Commons · CC BY-SA 3.0
FDA cleared510(k) · K260839FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared the Protaryx Transseptal Puncture Device under 510(k) K260839 on April 10, 2026, 28 days after receiving the submission.
  • The 510(k) summary says the device combines features of an East End Medical puncture system and Boston Scientific's VersaCross RF wire, which served as predicates.
  • Protaryx said a five-patient first-in-human study had procedural success in all cases; it plans to start US commercialization.

The US Food and Drug Administration has cleared Protaryx Medical's Transseptal Puncture Device, a tool for reaching the left side of the heart during catheter procedures, the Baltimore company announced on April 13, Medical Economics reported.

Many structural heart and electrophysiology procedures, including atrial fibrillation ablation, left atrial appendage closure and transcatheter mitral valve repair or replacement, require doctors to puncture the atrial septum, the wall between the heart's two upper chambers, to pass catheters into the left atrium.

A fast, third-party review

The FDA's 510(k) database lists the clearance as K260839 for the Protaryx Transseptal Puncture Device (PTX2-001). The agency received the traditional 510(k) on March 13, 2026, and found the device substantially equivalent on April 10, 2026. The record notes that the submission was reviewed by a third party, an accredited outside reviewer, before the FDA's decision. The device is classified as a catheter introducer and was reviewed by the cardiovascular panel.

According to the clearance letter and 510(k) summary, the device "is used to introduce various cardiovascular catheters to the heart, including the left side of the heart." It is a sterile, single-use introducer made up of a sheath, a dilator and a pigtail guidewire.

The summary names East End Medical's SafeCross Transseptal Puncture Device and Introducer System as the primary predicate and Boston Scientific's VersaCross RF Wire as a secondary predicate, with Boston Scientific's VersaCross Transseptal Sheath as a reference device. "The Protaryx Transseptal Puncture Device combines the features/ functions of these devices into a single device," the summary says.

Testing listed in the summary includes mechanical bench tests such as tip pull, kink and torque, a usability assessment in an animal study, biocompatibility, ethylene oxide sterilization validation and packaging and shelf-life testing.

Company claims and next steps

Protaryx said the device uses a zero-exchange delivery approach that removes the need for rewiring, an extendable and highly echogenic positioning probe meant to improve visibility on ultrasound, and a radiofrequency guidewire compatible with commonly used electrosurgical generators, according to Medical Economics.

The company reported that in an early first-in-human study of five patients, the system achieved procedural success in all cases with no device-related adverse events. That is company-reported data from a very small study.

"Receiving FDA 510(k) clearance is a defining moment," Chief Executive David Mester said in a statement. Co-founder James Gammie said the system could help expand use of minimally invasive procedures by simplifying left atrial access.

Protaryx said it plans to begin US commercialization following the clearance. It did not disclose pricing or a launch timeline in the coverage reviewed.

Sources

  1. FDA clears Protaryx Medical transseptal device aimed at improving left-heart access, Medical Economics, April 13, 2026
  2. 510(k) K260839: Protaryx Transseptal Puncture Device (database record), US Food and Drug Administration, April 10, 2026
  3. K260839 clearance letter and 510(k) summary, US Food and Drug Administration, April 10, 2026