Dr. Puttaswamy, the first operator to use image-guided atherectomy in Australia noted, “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.”
The bolded comment from the doctor's excerpt in the article told me that this product is just "another option" and not the sole option, or market leader it is hoping to be.
The thing is though FDA approval can come at any time. And given their last approval took 155 days, that puts us right into next week. That also takes into account subtracting 35 days for the government shutdown. Once FDA approval news hits, you won't be able to touch this under $1.