Positive Study Results Reported for Protaryx Medical’s Transseptal Puncture Tech

Protaryx Medical has completed a first-in-human study showing the significant potential of its advanced transseptal puncture technology.

“This achievement marks a pivotal step forward for Protaryx,” Protaryx Medical CEO David Mester said. “We are excited to advance toward 510(k) submission and bring our device to market, where it has the potential to redefine transseptal procedures.”

Conducted at Sanatorio Italiano de Asunción in Paraguay, the study enrolled five patients under approval from the Research Ethics Committee of the Paraguayan Institute of Social Studies. The procedures were performed by Dr. Adrian Ebner, head of the Cardiovascular Department at the Sanatorio Italiano Hospital, under the guidance by interventional cardiologist Dr. Gagan Singh (UC Davis Heath, Sacramento Calif.).

Dr. Singh described the transseptal access device as “the next evolution” in transseptal puncture. “The device substantially lowers the technical learning curve for targeted transseptal puncture due to its simplistic design, rapid echo visualization of septal contact, and ease of negotiating the septum until the desired target is acquired,” he stated.

The study met all procedural success endpoints with no adverse events. The device’s echogenicity facilitated rapid, targeted transseptal puncture with minimal fluoroscopic exposure. All five patients were discharged within 24 hours, reporting no complications and excellent therapeutic outcomes.

“The Protaryx device removes barriers for clinicians of all experience levels, making transseptal puncture safer and more efficient. It outperforms existing devices and sets a new standard for transseptal puncture” concluded Protaryx Co-Founder Dr. James Gammie, system chief of Cardiac Surgery at Johns Hopkins Health System.

The Protaryx Transseptal Puncture Device is a next-generation solution for transseptal puncture that improves access to the heart’s left side through the fossa ovalis. The device enables zero-exchange procedures, and incorporates a proprietary RF guidewire technology that is compatible with standard electrosurgical generators. Its extendable, highly echogenic atraumatic probe results in superior workflow efficiency. These advanced features provide unparalleled precision, safety, and efficiency, according to the company, making the system intuitive and accessible for operators of all experience levels.

Baltimore, Md.-based Protaryx Medical aims to enhance access and procedural efficiency in structural heart interventions. The Protaryx Transseptal Puncture Device delivers advancements in transseptal puncture, simplifying access to the heart’s left side of the heart while optimizing workflow.