Avinger asks for FDA approval of small-vessel PAD device

Avinger (NASDAQ:AVGR) has filed for 510(k) clearance of its Pantheris small-vessel “lumivascular” atherectomy device for treatment of peripheral artery disease (PAD).

The Pantheris small vessel (SV) device extends the company’s line of  Pantheris catheters, the first and only image-guided atherectomy devices for the treatment of PAD, which is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Designed with a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to target lesions in smaller-diameter vessels and more distal regions of the vasculature.

Get the full story on our sister site, Medical Design & Outsourcing.

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Avinger posts loss on disappointing sales

Avinger (NSDQ:AVGR) today posted a second-quarter losses-per-share that missed an analyst’s expectation, sending its share price down on Wall Street despite nearly halving its losses.

The Redwood City, Calif.-based medical device maker reported losses of -$6.6 million, or -98¢ per share, on sales of $2.1 million for the three months ended June 30, 2018. That compares with losses of -$12.8 million during Q2 2017 and amounts to a -14% top-line slide.

An analyst on The Street was looking for losses per share of -0.48¢ on sales of $2.6 million.

Positive news for the quarter included FDA clearance and initial sales of the company’s next-generation Pantheris image-guided atherectomy device and successful treatment of patients in several centers throughout the U.S. Avinger raised an additional $3.55 million in July 2018 from the sale of securities under a registered direct offering and hired new chief medical and financial officers.

“Receiving FDA clearance for our next generation Pantheris 3.0 was a key highlight of the second quarter and a significant milestone for Avinger. Following successful cases and positive physician feedback in initial U.S. sites, we are now focused on the commercial rollout of this next generation device to our installed base of accounts,” said Jeff Soinski, Avinger’s president & CEO, in a prepared statement. “We delivered strong sequential quarter revenue growth and made significant progress on the development of our pipeline products and in our clinical programs during the second quarter. We also added new capital to our balance sheet and made important new additions to our senior leadership team in recent months. I am pleased with the progress we are making as we return the company to growth and excited about our prospects for the future.”

Avinger’s share price fell by 6% to $1.20 at midday, nearly 10 times lower than one year ago.

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Avinger launches next-gen Pantheris in US

Avinger (NSDQ:AVGR) said today it launched its next-generation Pantheris in the US, touting that the first procedures with the device have already been performed.

Redwood City, Calif.-based Avinger said the newly launched Pantheris device features a single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. The system is designed to treat blocked peripheral blood vessels, using its Lumivascular optical coherence tomography technology, the company added.

“We are very pleased to deliver an enhanced device that will help Dr. Schwartzberg, and other physicians like him, produce better outcomes for patients. Our first US cases confirm many of the design changes incorporated into the next-generation Pantheris have improved performance and durability of the technology. Gaining experience across multiple users in the United States, different physician specialties, and a variety of lesion characteristics further substantiates the results generated with the next-generation device in Europe over the past few months,” prez & CEO Jeff Soinski said in a press release.

The new system has been used to treat over 40 patients in the US at 13 sites, and adds to 30 initial cases performed in Germany earlier this year, Avinger said.

“I am very excited about the outcomes for patients that the next-generation Pantheris has helped me achieve in my initial 10 cases. Since the infancy of this technology, I have always thought onboard image-guided atherectomy represented the future of endovascular intervention for many types of disease because of its ability to target specific pathology as opposed to other atherectomy devices which indiscriminately engage both normal and abnormal tissue, potentially creating harm. While still early in our experience with the device, the new design features have already expanded the applicability of Pantheris to a wider variety of lesion types and I have observed a marked improvement in cutting efficiency and ease of use. I use Pantheris as my front-line therapy due to its safety profile with the reduction of radiation and contrast delivery to the patient and my firm belief that this approach will generate better long-term results for patients. The data from the Vision trial with the first-generation Pantheris demonstrated the longer-term efficacy and safety of this therapy, and the body of evidence should only grow from here,” Dr. Glen Schwartzberg, who was the first to use the next-gen device, said in a prepared statement.

Earlier this month, Avinger said it launched a post-market study comparing optical coherence tomography to intravascular ultrasound as used during interventions in the peripheral arteries.

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Avinger wins FDA nod for next-gen Pantheris

Avinger (NSDQ:AVGR) said today it won FDA 510(k) clearance for its next-gen Pantheris lumivascular atherectomy system, which it touts as the first image-guided atherectomy device designed for treating peripheral artery disease.

Redwood City, Calif.-based Avinger said the newly cleared Pantheris device features a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. The system is designed to treat blocked peripheral blood vessels, using its Lumivascular optical coherence tomography technology, the company added.

“We are excited to introduce the next generation Pantheris to our network of physicians here in the United States. After extensive testing by our R&D and operations teams, physician design validation, and successful initial case experience in Europe across a variety of different lesion types, we believe this next generation device will significantly improve the user experience in terms of reliability, efficiency, and ease of use across a spectrum of clinical situations,” prez & CEO Jeff Soinski said in a prepared statement.

The system won CE Mark approval in the European Union last December, and has been actively used in Germany since winning approval, the company said.

Avinger said it plans to launch two version of the device at initial sites in the US immediately, and will incoporate the new design into an IDE clinical trial currently in progress examining the use of the system for treating in-stent restenosis in lower extremity arteries.

“The Pantheris Lumivascular atherectomy system has allowed me to treat peripheral artery disease with more precision while largely avoiding trauma to the blood vessel during an intervention. Unlike some other products, this technology’s performance can stand on its own but also enhance other forms of adjunctive therapy if needed, while preserving future treatment options for the patient. As one of the first users of the initial generations of Pantheris, I have been eagerly awaiting the product enhancements incorporated into the new system, which has the promise of not only improving ease of use, but also providing a new level of operator control during the procedure,” Dr. Barry Tedder of Jonesboro, Ark.’s St. Bernards Medical Center said in a press release.

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Avinger inks $15m share purchase deal

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    AvingerShares in Avinger have fallen over 15% today after the medical device maker missed expectations on Wall Street with its 1st quarter earnings results.

    The Redwood City, Calif.-based company posted losses of $15.3 million, or 64¢ per share, on sales of $3.5 million for the 3 months ended March 31, seeing losses shrink 5.1% while sales shrunk by 23.1% compared with the same period in the previous fiscal year.

    Read the whole story on our sister site, Medical Design & Outsourcing