December 6, 2018—Avinger, Inc. announced the commercial launch of its Pantheris Lumivascular image-guided atherectomy system in Australia. The company received notice from Australia’s Therapeutic Goods Administration that the Pantheris system has been included on the Australian Register of Therapeutic Goods, which permits distribution in Australia.
Avinger advised that it recently completed an exclusive distribution agreement with Diverse Devices Pty Ltd. for sale and marketing of Avinger’s Lumivascular products in Australia.
According to the company, the device combines real-time intravascular imaging with catheters for the treatment of peripheral artery disease. Lumivascular technology allows physicians to see from inside the artery during an atherectomy procedure by using optical coherence tomographic imaging that is displayed on Avinger’s Lightbox console.
Vikram Puttaswamy, MD, performed the first cases with Pantheris in Australia after regulatory clearance. Dr. Puttaswamy is a vascular surgeon at North Shore Private Hospital in Sydney, Australia. Additional cases were performed by Yew Toh Wong, MD, a vascular surgeon at Flinders Medical Center in Adelaide, Australia. Pantheris was used to successfully treat lesions in five patients primarily in the superficial femoral artery and included a case with in-stent restenosis.
In the company's announcement, Dr. Puttaswamy commented, “Maximizing the channel for blood flow in revascularizing the vessel, while simultaneously minimizing vascular injury is the goal in treating patients with PAD. This new device provides another option for Australian clinicians when treating patients with this serious disease.”
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