FDA clears Avinger’s Pantheris for in-stent restenosis

Avinger this week announced that it received FDA 510(k) clearance for a new clinical indication for its Pantheris image-guided atherectomy system.

The new indication allows the Redwood City, California-based company to market the device for in-stent restenosis (ISR) treatment in the lower extremity arteries.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Avinger reports Street-beating revenues in Q2

Avinger (NSDQ:AVGR) shares stood still this morning on second-quarter sales numbers that topped the consensus forecast.

The Redwood City, Calif.-based image-guided catheter developer posted losses of -$3.5 million on sales of $2.8 million for the three months ended June 30, 2021, for a 43.1% bottom-line gain on sales growth of 9.5%.

Earnings per share came in at -4¢, level with projections on Wall Street, where analysts were looking for sales of $2.7 million.

“Avinger’s 2021 growth momentum continued in the second quarter as we delivered strong revenue gains for both our Pantheris atherectomy and image-guided CTO product lines and procedural volume improving in the first half of the year,” Avinger president & CEO Jeff Soinski said in a news release. “Pantheris SV has been a standout solution, generating strong user interest based on its compelling clinical advantages in the treatment of below-the-knee lesions. We are also benefitting from…

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Avinger slides on mixed bag Q4 results

Avinger (NSDQ:AVGR) posted fourth-quarter results today that missed the earnings consensus on Wall Street but matched on sales.

The Redwood City, Calif.-based company reported losses of -$4.6 million, or -7¢ per share, on sales of $2.73 million for the three months ended Dec. 31, 2020, for a sales growth of 18.68% compared with Q4 2019.

Earnings per share were -7¢ per share, 1¢ behind The Street, where analysts were looking for sales of $2.73 million.

“Avinger remains focused on driving top-line growth by introducing new products, launching new accounts and expanding utilization at existing sites. In January, we progressed to full commercial launch of Tigereye, our next generation CTO-crossing device, following the completion of a successful limited launch program in the fourth quarter. Patient outcomes are compelling as more and more sites complete their first cases with this new device, demonstrating the benefits of Tigereye’s enhanced imaging, steerab…

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