Protarix transseptal puncture device receives FDA clearance to reduce cardiac procedure complications

Medical device company Protarix Medical has secured a foothold for entering the U.S. market after its transseptal puncture device received clearance from the U.S. Food and Drug Administration (FDA).

On the 15th (local time), Protarix Medical announced that it had received FDA 510(k) clearance for its “transseptal puncture device,” which is used in minimally invasive left atrial procedures. The clearance provides a positive signal for the company’s strategy of improving the safety and efficiency of cardiac procedures.

The device supports a “zero-exchange” approach that eliminates the need to exchange catheters during a procedure. It also features a proprietary atraumatic design that reduces the number of procedural steps and the need for rewiring, improving workflow efficiency.

In particular, it integrates a highly echogenic, expandable atraumatic positioning probe with a standard RF guidewire compatible with commercially available electrosurgical generators. This enables precise transseptal puncture (TSP) at the target site, reducing the risk of device alignment errors, procedural complexity and complications.

In an earlier first-in-human (FIH) study involving five patients, the device achieved procedural success in all cases, and no device-related adverse events were reported. The study also confirmed that it minimized the time required to cross the atrial septum and reduced exposure to fluoroscopic radiation.

David Mester, CEO of Protarix Medical, said, “This FDA 510(k) clearance is a pivotal moment for Protarix. We can now make this innovative technology available to physicians and patients across the United States.”

Following the FDA clearance, Protarix Medical plans to begin commercialization in the United States and expand adoption in clinical practice.