Avinger

Avinger Announces 510(k) Filing of Pantheris LV

Avinger (AVGR) Announces 510(k) Filing of Pantheris LVPantheris LV Represents the Next-Generation of Onboard Image-Guided Technology for the Treatment of Peripheral Artery Disease Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the Company submitted a new 510(k) application to the U.S. Food & Drug Administration (FDA) for Pantheris LV, its next-generation image-guided atherectomy system for the treatment of larger vessels, such as the SFA and popliteal arteries, where the majority of PAD procedures are performed today. Pantheris LV offers multiple benefits to physician users, including higher speed plaque excision for efficient removal of challenging occlusive tissue and multiple features to streamline and simplify user-operation, including enhanced tissue packing and removal, a radiopaque gauge to measure volume of plaque removal during the procedu...

Atherectomy catheters with imaging

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An atherectomy catheter includes an elongate flexible catheter body, an elongate deflectable distal tip coupled to the catheter body at a hinge point, a rotatable cutter near the distal end of the catheter body, and a drive shaft extending within the catheter body and configured to rotate the cutter. The atherectomy catheter further includes an optical fiber extending through the drive shaft substantially on-axis with the catheter body and attached to the cutter. The optical fiber is configured to rotate with the drive shaft. The atherectomy catheter further includes a wedge configured to deflect the distal tip away from the catheter body at the hinge point upon axial movement of the drive shaft.   ( Read Full Article )

Atherectomy catheter

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Described herein are atherectomy catheters, systems and methods that include longitudinally displaceable drive shafts that drive actuation of one or more cutters at the distal end of the catheter. The catheters described herein may include one or more imaging sensors for imaging before, during or after cutting tissue. In some variations the imaging sensor may be rotated around the perimeter of the catheter independently of the rotation of the cutter. Also describe herein are imaging catheters that may be used without cutters. ( Read Full Article )

Avinger Expands International Presence with First Commercial Shipment to Chile

Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the expansion of its international presence with the commercial launch of its Lumivascular products in Chile. Avinger's new Lightbox 3 imaging console will be used exclusively to support the launch of the Lumivascular platform in Chile. To support the entry into this new international market, Avinger has signed an exclusive distribution agreement with Importadora y Distribuidora Arquimed Ltda for the sale and marketing of Avinger's proprietary Lightbox 3 imaging console and image-guided Pantheris atherectomy and Tigereye CTO-crossing catheters in Chile. Arquimed is a leading distributor in the medical field in Chile with more than 80 years of successful operating history and approximately 360 employees throughout the country. "We are excited to expand our g...

OCT imaging catheter with lag correction

A catheter system includes a catheter body, an imaging sensor, a drive motor, a current sensor, a display, and a controller. The catheter body includes a drive shaft. The imaging sensor is fixed relative to the distal end of the driveshaft and is configured to rotate therewith. The drive motor is configured to rotate the drive shaft. The current sensor is configured to measure an amount of current drawn by the drive motor as the drive shaft is rotated. ( Read Full Article )

Avinger Announces Successful Completion of First Cases with the Lightbox 3 Next Generation Imaging Console

Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that physicians in the U.S. have successfully completed first cases with its new Lightbox 3 imaging console. The Lightbox 3 received 510(k) pre-marketing clearance from the U.S. Food & Drug Administration (FDA) in January. Avinger is expanding availability of the Lightbox 3 to additional sites on a limited basis and anticipates progressing to full commercial availability early in the second quarter of 2022. Over the past week, Dr. Jaafer Golzar, an interventional cardiologist and Avinger's Chief Medical Officer, and Dr. Ian Cawich, an interventional cardiologist at Arkansas Heart Hospital, used the Lightbox 3 to complete a total of 15 image-guided CTO-crossing and atherectomy procedures with Avinger's Tigereye and Pantheris catheters. Both physicians tr...

Avinger Announces $7.6 Million Registered Direct Offering

Avinger, Inc. (NASDAQ:AVGR) (the "Company"), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that it has entered into a definitive agreement with certain institutional investors for the issuance and sale in a registered direct offering of an aggregate of 7,600 shares of Series D convertible preferred stock (the "Preferred Stock") and warrants to purchase up to an aggregate of 16,150,000 shares of common stock for gross proceeds of $7.6 million. The shares of Preferred Stock will have a stated value of $1,000 per share and are convertible into an aggregate of 19,000,000 shares of common stock at a conversion price of $0.40 per share. The Preferred Stock will not be convertible until after the effective date of an amendment to the Amended and Restated Certificate of Incorporation of the Company to effect a reverse stock split at a rat...

Avinger Announces FDA Clearance of Pantheris for the Treatment of In-Stent Restenosis

New indication expands addressable market for Pantheris Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for a new clinical indication for the Pantheris image-guided atherectomy system. This clearance allows the company to directly market Pantheris for the treatment of in-stent restenosis (ISR) in the lower extremity arteries. "We are excited to receive FDA clearance for the ISR indication, which expands our addressable market for Pantheris to include a high-incidence disease state for which there are few available indicated treatment options," commented Jeff Soinski, Avinger's President and CEO. "Pantheris is now the only directional atherectomy device to have a clinical indication for the treatment of in-stent reste...

Avinger Announces 510(k) Filing for New Lightbox 3 Imaging Console

Smaller Footprint, Improved User Experience and Lower Cost to Drive Adoption Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the submission of a 510(k) application to the U.S. Food & Drug Administration (FDA) for its new Lightbox 3 imaging console. "Avinger's Lightbox 3 represents an important leap forward in imaging, portability and capability," commented Jeff Soinski, Avinger's President and CEO. "The Lightbox 3's compact size, next generation laser system and streamlined workflows are anticipated to accelerate the pace and efficiency of new account acquisition, energize existing users and provide the opportunity to support new catheter capabilities in the future. The filing of this 510(k) submission is a major accomplishment for our team, and we are excited about the potential for the Lightbox 3 t...

Micro-molded anamorphic reflector lens for image guided therapeutic/diagnostic catheters

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A catheter system for optical coherence tomography includes an elongate catheter body, an optical fiber in the elongate catheter body, and an anamorphic lens assembly coupled with a distal end of the optical fiber. The optical fiber and the lens assembly are together configured to provide a common path for optical radiation reflected from a target and from a reference interface between the distal end of the optical fiber and the lens assembly. ( Read Full Article )

New Publications Highlight Clinical Benefits of Avinger PAD Therapies

Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the publication of two clinical studies in peer-reviewed journals, further supporting the clinical benefits of its therapeutic devices. The studies were based on separate clinical case series conducted by physicians at the Division of Cardiovascular Disease and Endovascular Medicine at the Einstein Medical Center in Philadelphia, Pennsylvania. "These two studies demonstrate the utility of Avinger's OCT-guided approach for the treatment of PAD in complex and challenging cases and patient populations," commented Dr. Jon George, an interventional cardiologist and endovascular specialist at the University of Pennsylvania Health System and an author of both publications. "Due to the small size of the vessels being treated below-the-knee (BTK), the limited treatm...

Single-Center Experience With Optical Coherence Tomography-Guided Directional Atherectomy System for Below-the-Knee Critical Limb Ischemia

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Background. Below-the-knee (BTK) peripheral arterial disease (PAD) more often presents as critical limb ischemia. Endovascular revascularization strategies continue to evolve to achieve long-term limb-salvage outcomes. A single-center experience with optical coherence tomography (OCT)-guided atherectomy using Pantheris SV (Avinger) is reported. Methods. All patients with PAD in femoropopliteal or infrapopliteal vessels (n = 27) who underwent plaque debulking by Pantheris SV were analyzed retrospectively. Baseline comorbidities, Rutherford classification, lesion length and characteristics, adjunctive treatment strategy, device-related failures/complications, and major adverse events were analyzed. Additionally, 6-month target-lesion revascularization (TLR) rate was available for 21 of 27 patients. Results. Mean patient age was 70.5 years, 16 patients (59%) were women, and 19 patients (70%) had Rutherford class 5 to 6 symptoms. A total of 58 vessels were treated, including 32 iliofemo...

Clinical Trials Critical for the Evaluation of Advanced Medical Imaging Tools

Image-guided surgery offers surgeons greater control of the procedure and real-time feedback, thus providing better outcomes for patients. Accuracy in surgical procedures is critical for serious or life-threatening conditions, such as cancer, and medical technology companies are providing imaging tools to help surgeons deliver better results to their patients. Companies such as Perimeter Medical Imaging AI (TSXV:PINK), Butterfly Network (NYSE: BFLY ), ENDRA Life Sciences Inc. (NASDAQ: NDRA ), Asensus Surgical Inc. (NYSE: ASXC ), and Avinger Inc. (NASDAQ: AVGR ) have engaged in the research and development of advanced imaging tools for use in different procedures. In addition to the development of these tools, these companies are seeking regulatory approval and collaborating in clinical studies that provide data on the application of these imaging tools. ( Read Full Article )

Occlusion-crossing devices

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A catheter device for crossing occlusions includes an elongate catheter shaft, a rotatable tip configured to rotate relative to the elongate catheter shaft, a drive shaft, and an OCT imaging sensor. The rotatable tip includes a housing coupled with the elongate catheter shaft and cutting wedges extendable from the housing. The drive shaft has a central lumen extending therethrough and extends within the elongate catheter shaft. The drive shaft is coupled with the wedges and is configured to rotate the rotatable tip. The OCT sensor includes an optical fiber coupled with the rotatable tip and configured to rotate therewith. The elongate catheter shaft is configured to move axially over the drive shaft to extend and retract the wedges from the housing while maintaining a fixed position of the imaging sensor relative to the cutting wedges. ( Read Full Article )

Avinger surges on news of patent win

Avinger (NASDAQ: AVGR ) has added ~58.6% so far in the premarket on slightly below-average volume. There appears to be no company-specific news except social media chatter regarding a recent patent win secured by the firm. The patent, titled 11041-719.US0: optical pressure sensor assembly, was to be issued to Avinger, the data from the US Patent and Trademark Office indicate . However, the company has yet to make an official statement. Similarly, in 2019, Avinger shares surged in the premarket on the news of its patent win related to the optical coherence tomography (“OCT”) intravascular imaging system . ( Read Full Article )

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