PAD specialists announce new FDA clearance for image-guided atherectomy system
Avinger, a California-based medical device company specializing in peripheral artery disease, has gained FDA clearance for its Pantheris image-guided atherectomy system to treat in-stent restenosis (ISR) in the lower extremity arteries.
According to the company, this new clinical indication helps Pantheris stand out against other atherectomy solutions.
“We are excited to receive FDA clearance for the ISR indication, which expands our addressable market for Pantheris to include a high-incidence disease state for which there are few available indicated treatment options,” Jeff Soinski, Avinger's President and CEO, said in a prepared statement. “Pantheris is now the only directional atherectomy device to have a clinical indication for the treatment of in-stent restenosis, providing a compelling new point of differentiation for the device. By combining real-time intravascular imaging with the precise control and large luminal gain of directional atherectomy, Pantheris enables physicians to visualize stent struts and safely target ISR lesions to restore blood flow to occluded vessels, while avoiding the structure of the previously implanted stent.”
It's estimated that 30% to 40% of stents placed in the femoral and popliteal arteries will go on to develop ISR within three years. Glen Schwartzberg, MD, a vascular surgeon with experience studying the Pantheris system, said in the same statement that this new indication could help clinicians treating ISR “reduce the need for repeat interventions and more invasive surgeries.”
“The Pantheris system's combination of onboard image-guidance and a directional excision mechanism provides significant clinical advantages in treating in-stent restenosis not available with any other therapy,” Schwartzberg added. “This technology allows the operator to target only the blockage and maximize the channel for restored blood flow while avoiding negative interactions with clearly delineated stent struts.”
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