Avinger Inc (NASDAQ:AVGR) a key developer of unique treatments for Peripheral Artery Disease reported Conformité Européenne Marking approval for curing in-stent restenosis using the Pantheris® Lumivascular atherectomy system.
The details
In-stent restenosis happens when an earlier blocked artery cured with a stent becomes narrowed again, obstructing blood flow. Doctors often face challenges when curing in-stent restenosis both in respect of efficacy and safety. From a safety viewpoint, limitations in imaging techniques like X-ray fluoroscopy and the failure to control the directionality of other cure modalities’ mechanism of action produces the concern of possibly impacting the reliability of the stent during the process. In terms of efficacy, prevailing treatments for in-stent restenosis like balloon angioplasty face high rates of repeated renarrowing within stents.
Jeff Soinski, the CEO and President of Avinger, reported that the demand for enhanced treatment alternatives for in-stent restenosis is rising as physicians experience the accurate precision and visualization offered by advanced know-hows like the Pantheris Lumivascular atherectomy system. CE Marking for this specific indication is a vital milestone for Avinger that resolves an area of unmet clinical need for people suffering from PAD. Onboard image projection together with directional plaque excision provides the interventionist clear advantages when treating in-stent restenosis and signifies another opportunity to enhance patient outcomes.
John B. Simpson, Ph.D., M.D., the Executive Chairman and Founder, said that two elements considerate interventionists look to avoid during intervention are stent struts and adventitia. Intravascular visualization together with a directional mechanism in real time offers operators the precision and information required to cure only unhealthy tissue without coming into contact with the adventitia or stent struts. Atherectomy marks as a minimally invasive cure for Peripheral Artery Disease in which a catheter-based device is utilized to eliminate plaque from a blood vessel.
Lumivascular technology enables physicians to view from inside the artery while a directional atherectomy procedure is performed. It is done by utilizing an imaging modality named optical coherence tomography that is shown on the Lightbox console. Earlier, physicians have had to depend merely on X-ray and tactile feedback to lead their tools while curing complicated arterial disease.
