REDWOOD CITY, Calif., Oct. 14, 2015 (GLOBE NEWSWIRE) -- Avinger, Inc., (NASDAQ:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the Lumivascular approach to treating vascular disease, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to commence U.S. commercialization of its Pantheris image-guided atherectomy system for the treatment of patients with PAD. Pantheris combines directional atherectomy with real-time, intravascular visualization and is designed to empower physicians to precisely remove plaque from blocked arteries, while avoiding disruption of normal arterial wall structures.
"On behalf of all the employees at Avinger, I want to first thank all of the patients who agreed to participate in the VISION trial. It is obvious the clearance today of Pantheris for commercial launch in the U.S. could not have happened without the physicians and hospital staffs who so diligently performed in the VISION trial. I extend my thanks to all of them. I recognize this is only the beginning, but my hope is this is the first small step in the beginning of a revolution that will lead to better acute and long-term outcomes for PAD patients using an imaging modality that does not rely on radiation," said Dr. John Simpson, Founder and Executive Chairman of Avinger. "With the availability of Pantheris, doctors can now have real-time images from the catheter tip which will allow them to better target and treat the parts of the artery that are obstructing blood flow while sparing the normal parts of the artery. This provides physicians a compelling alternative to existing devices in the majority of PAD procedures."
Clearance of Pantheris comes on the heels of completion of the VISION IDE trial in which Pantheris exceeded the study's safety and efficacy endpoints. Six-month results from an interim analysis of 93 patients out of the 130 patients treated per protocol in the study were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco on October 13, 2015. Data from this interim cohort was the basis for the 510(k) application Avinger submitted to the U.S. Food and Drug Administration (FDA) on August 12, 2015.
Previously released VISION results demonstrated:
- Residual stenosis of less than or equal to 50% was achieved in 96% of lesions following standalone treatment with Pantheris, surpassing the primary efficacy endpoint performance goal of 87%;
- Target lesion revascularization (TLR) rate of 10.8% and overall major adverse event (MAE) rate of 21.5% through six-month follow-up in the interim analysis cohort, measuring below the pre-defined study limit for MAEs of 43.2%;
- Zero clinically significant dissections or perforations during the Pantheris procedure;
- Statistically significant improvement across all patients in both blood flow measurement (Ankle Brachial Index) and symptom-based outcomes (Rutherford Classification); and
- Stent placement in only 4% of lesions following treatment with Pantheris.
Histologic results are expected to be a key differentiator in the VISION trial. These findings will be used to further support the Avinger hypothesis that minimizing arterial wall disruption during therapy promotes reduced adjunctive treatments, improved long-term arterial patency, and ultimately minimizes the need for re-intervention. The average percent area of adventitia, an indicator of arterial wall disruption, in the atherectomy tissue samples collected was just 1.0% across all lesions treated and analyzed for histology.
"This achievement represents our continued commitment to bring to market the most advanced technology for physicians and their patients affected by PAD," said Jeff Soinski, Chief Executive Officer of Avinger. "Pantheris received CE-Mark during the second quarter of this year, which has provided an excellent opportunity for us to gain additional clinical experience in Europe with enhanced versions of Pantheris designed to improve user interface and streamline the procedure. We anticipate broad-scale commercial launch of an enhanced version of Pantheris in the U.S. within the first quarter of 2016, following receipt of the appropriate regulatory approvals."
Pantheris is the first-ever image-guided atherectomy device using real-time intravascular visualization technology. Pantheris is the subject of the VISION IDE trial, a ground-breaking study designed to evaluate the safety and efficacy of Pantheris for directional atherectomy in the peripheral arteries, while allowing physicians to use high resolution Optical Coherence Tomography (OCT) intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
About Avinger, Inc.
Avinger, Inc. is a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems for the treatment of patients with peripheral arterial disease (PAD). PAD is characterized by a build-up of plaque in the arteries that supply blood to the arms and legs. The Company's mission is to dramatically improve the treatment of vascular disease through the introduction of products based on its lumivascular platform, the only intravascular image-guided system of therapeutic catheters available in this market. Avinger's current lumivascular products include the Lightbox™ imaging console, the Ocelot™ family of catheters, which are designed to penetrate total arterial blockages, known as chronic total occlusions, or CTOs, and Pantheris™, the first-ever image-guided atherectomy device, designed to precisely remove arterial plaque in PAD patients. For more information, please visit the Company's website at www.avinger.com.
"Avinger," "Pantheris" and the Avinger logo are registered trademarks of Avinger, Inc.
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding planned regulatory and commercialization activities, expected histology results and adoption of Pantheris for treatment of PAD. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include our dependency on a limited number of products; ability to demonstrate the benefits of our lumivascular platform; the resource requirements related to Pantheris, which has not been approved and may not be approved; the outcome of clinical trial results including our VISION Trial; potential exposure to third-party product liability and intellectual property litigation; lack of long-term data demonstrating the safety and efficacy of our lumivascular platform products; reliance on third-party vendors; dependency on physician adoption; reliance on key personnel; and requirements to obtain regulatory approval to commercialize our products; as well as the other risks described in the section entitled "Risk Factors" in our Form 10-Q filing made with the Securities and Exchange Commission on August 12, 2015. These forward-looking statements speak only as of the date hereof. Avinger disclaims any obligation to update these forward-looking statements.