First patients treated with Avinger’s next generation atherectomy device

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Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the first use of their next generation Pantheris lumivascular atherectomy system. The device was used by vascular surgeon Arne Schwindt to treat patients at St Franziskus Hospital in Münster, Germany.

Schwindt, an experienced operator of Lumivascular technology, used the next generation Pantheris to treat seven separate patients with a variety of lesion types, including in-stent restenosis (ISR), a calcified lesion and a chronic total occlusion, in arteries above and below the knee.

The next generation Pantheris design includes a simplified single balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability, a more robust nose cone with the option for more tissue storage capacity and an enhanced cutter design. The device is available in limited supply for commercial sale in the EU; it is not available commercially in the USA at this time.

In each of the seven cases, Pantheris performed as intended, and Schwindt made note of the design features that enabled significant performance improvements as compared to previous versions of the device, including better directional control of the cutter blade for more precise atherectomy.

Schwindt also provided feedback about the increased maneuverability of the system, greater tissue capture versus the similarly sized previous version of Pantheris, increased efficiency and ease of cleaning the device between insertions, and high quality imaging in a variety of vessel diameters.

In commenting on his initial cases, which included a patient with a total occlusion of a stent and multiple below-the-knee lesions, Schwindt noted, “Next generation Pantheris with real-time image guidance enabled me to see the stent struts and precisely target and remove substantial amounts of tissue that had grown into the stent. In two patients the disease extended below the knee. Image-guided atherectomy with the next generation Pantheris made it possible to precisely target and remove atherosclerotic plaque in this region while conserving the deep wall components and thus reducing the risk of perforations in these small vessels. The angiographic outcome was excellent.”

“We are thrilled that Dr Schwindt was the first in the world to use the next generation of Pantheris, especially given the excellent outcomes for patients in this initial experience with the device,” said Jeff Soinski, Avinger’s president and CEO. “These cases helped to validate the enhancements we have made to Pantheris, both in terms of performance and reliability.”

Lumivascular technology is allowing physicians, for the first time ever, to see from inside the artery during an atherectomy procedure by using optical coherence tomography (OCT) that is displayed on Avinger’s proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions while treating complicated arterial disease.

With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionising radiation.

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