The system is designed to improve workflow efficiency and safety during minimally invasive left-heart procedures.
Protaryx Medical has received 510(k) clearance from the Food and Drug Administration (FDA) for its Transseptal Puncture Device. The system is designed to provide access for minimally invasive left-heart procedures.
The device aims to facilitate site-specific transseptal puncture (TSP) to optimize positioning for cardiac interventions. According to the company, this approach reduces the risk of suboptimal device alignment, procedural complexity, and clinical complications.
System Design and Workflow
The system features a zero-exchange delivery design and an atraumatic positioning probe intended to reduce procedural steps and the need for rewiring. The device also includes a highly echogenic, extendable probe for visualization and a standardized RF guidewire compatible with commercially available electrosurgical generators.
“Receiving FDA 510(k) clearance is a defining moment for Protaryx,” says David Mester, chief executive officer of Protaryx Medical, in a release. “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.”
Clinical Study Results
In an early First-in-Human study of five patients, the device demonstrated procedural success in all cases. The study reported no device-related adverse events, minimal crossing time, and reduced fluoroscopic exposure.
“This clearance underscores the strength of the technology and its potential to set a new standard for transseptal puncture,” says James Gammie, Protaryx co-founder and system chief of cardiac surgery at Johns Hopkins medicine, in a release. “By simplifying access to the left atrium, the device can expand procedural adoption while improving safety, precision, and ease-of-use.”
Gagan Singh, an interventional cardiologist at UC Davis Health who participated in the study, noted the device’s echogenicity and atraumatic design, highlighting its ability to reduce the learning curve for targeted procedures, according to the company.
Protaryx Medical plans to initiate US commercialization and expand clinical adoption following the FDA clearance.
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