Avinger Releases Updated Data From IMAGE-BTK in Webinar Featuring Key Opinion Leaders in the Field of Vascular Intervention
Avinger hosted a webinar featuring key opinion leaders discussing new approaches to treating Peripheral Artery Disease (PAD) Below-the-Knee (BTK). The webinar presented updated data from the IMAGE-BTK study, which evaluated the safety and efficacy of Pantheris SV device in BTK procedures. The study enrolled 51 patients with 58 lesions, with follow-up data on 45 patients at 6 months and 33 patients at 12 months. Results showed 100% freedom from major adverse events at 30 days, 97% freedom from target lesion revascularization, and 94% primary patency at 12 months. The Lumivascular technology incorporates real-time OCT imaging guidance for more accurate navigation during procedures.
Avinger ha ospitato un webinar con esperti leader d'opinione che hanno discusso nuovi approcci per il trattamento della malattia arteriosa periferica (PAD) sotto il ginocchio (BTK). Il webinar ha presentato dati aggiornati dello studio IMAGE-BTK, che ha valutato la sicurezza e l'efficacia del dispositivo Pantheris SV nelle procedure BTK. Lo studio ha arruolato 51 pazienti con 58 lesioni, con dati di follow-up su 45 pazienti a 6 mesi e 33 pazienti a 12 mesi. I risultati hanno mostrato una libertà dal 100% di eventi avversi maggiori a 30 giorni, una libertà dal 97% di rivascolarizzazione della lesione target, e una patente primaria del 94% a 12 mesi. La tecnologia Lumivascular incorpora una guida all'immagine OCT in tempo reale per una navigazione più precisa durante le procedure.
Avinger organizó un seminario web con líderes de opinión clave discutiendo nuevos enfoques para el tratamiento de la enfermedad arterial periférica (PAD) por debajo de la rodilla (BTK). El seminario web presentó datos actualizados del estudio IMAGE-BTK, que evaluó la seguridad y eficacia del dispositivo Pantheris SV en procedimientos BTK. El estudio inscribió a 51 pacientes con 58 lesiones, con datos de seguimiento de 45 pacientes a 6 meses y 33 pacientes a 12 meses. Los resultados mostraron 100% de libertad de eventos adversos mayores a 30 días, 97% de libertad de revascularización de la lesión objetivo, y 94% de patencia primaria a 12 meses. La tecnología Lumivascular incorpora una guía de imagen OCT en tiempo real para una navegación más precisa durante los procedimientos.
Avinger는 주요 의견 리더들이 무릎 아래 말초동맥질환(PAD) 치료에 대한 새로운 접근 방식을 논의하는 웨비나를 주최했습니다. 이 웨비나는 BTK 절차에서 Pantheris SV 장치의 안전성과 유효성을 평가한 IMAGE-BTK 연구의 업데이트된 데이터를 발표했습니다. 연구에는 58개의 병변을 가진 51명의 환자가 등록되었으며, 6개월에 45명의 환자, 12개월에 33명의 환자에 대한 추적 데이터가 포함되었습니다. 결과는 30일 이내 주요 부작용으로부터 100% 자유, 목표 병변 재혈관화로부터 97% 자유, 그리고 12개월 기준으로 94%의 주 펠렛을 보여주었습니다. Lumivascular 기술은 절차 중 보다 정확한 내비게이션을 위한 실시간 OCT 이미지 가이드를 통합합니다.
Avinger a organisé un webinaire mettant en vedette des leaders d'opinion clés discutant de nouvelles approches pour traiter la maladie artérielle périphérique (PAD) sous le genou (BTK). Le webinaire a présenté des données actualisées de l'étude IMAGE-BTK, qui a évalué la sécurité et l'efficacité de l'appareil Pantheris SV lors des procédures BTK. L'étude a inclus 51 patients avec 58 lésions, avec des données de suivi sur 45 patients à 6 mois et 33 patients à 12 mois. Les résultats ont montré une liberté de 100 % des événements indésirables majeurs à 30 jours, une liberté de 97 % de revascularisation de la lésion cible, et une patence primaire de 94 % à 12 mois. La technologie Lumivascular intègre une imagerie OCT en temps réel pour une navigation plus précise lors des procédures.
Avinger veranstaltete ein Webinar mit führenden Meinungsträgern, die neue Ansätze zur Behandlung der peripheren arteriellen Erkrankung (PAD) unterhalb des Knies (BTK) diskutierten. Das Webinar präsentierte aktualisierte Daten aus der IMAGE-BTK-Studie, die die Sicherheit und Wirksamkeit des Geräts Pantheris SV bei BTK-Eingriffen bewertete. Die Studie rekrutierte 51 Patienten mit 58 Läsionen und hatte Follow-up-Daten von 45 Patienten nach 6 Monaten und 33 Patienten nach 12 Monaten. Die Ergebnisse zeigten eine 100%ige Freiheit von schwerwiegenden unerwünschten Ereignissen nach 30 Tagen, eine 97%ige Freiheit von der Re-Intervention der Zielläsion und eine 94%ige primäre Patency nach 12 Monaten. Die Lumivascular-Technologie integriert eine Echtzeit-OCT-Bildführung zur genaueren Navigation während der Verfahren.
- 100% freedom from major adverse events at 30 days
- 97% freedom from target lesion revascularization at 12 months
- 94% primary patency rate at 12 months
- 0% all-cause mortality at 30 days
- No major unplanned amputations reported
- None.
Insights
The updated IMAGE-BTK study data reveals compelling clinical outcomes for Avinger's Pantheris SV device in treating below-the-knee PAD. Key findings include
The device's unique combination of OCT imaging guidance with directional atherectomy provides superior vessel visualization while reducing radiation exposure. This technological advantage, coupled with the strong safety and efficacy data, positions Pantheris SV as a potential standard of care for BTK interventions. However, the relatively small patient cohort (51 patients) suggests further validation may be needed for broader market adoption.
While the clinical data is promising, AVGR's micro-cap status (
The endorsement from key opinion leaders and strong clinical outcomes could drive adoption among vascular specialists, potentially leading to increased procedure volumes. However, investors should consider the company's financial position and ability to scale operations to capitalize on this opportunity. The path to profitability and market expansion will likely require additional capital raising, which could impact shareholder value.
REDWOOD CITY, CA / ACCESSWIRE / October 24, 2024 / 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 vascular disease hosted a physician-focused webinar entitled, "New Approaches to Treating Peripheral Artery Disease (PAD) Below-the-Knee (BTK) and Promising New BTK Data." A recording of the webinar may be accessed at https://pages.avinger.com/webinar-new-approaches-to-treating-btk-pad.
The webinar featured key opinion leaders in the field of vascular intervention from different specialties and geographies as follows:
Dr. Michael Lichtenberg, an angiologist and the Chief Medical Officer and Director of the Angiology Department and Vascular Center at the Arnesberg Clinic in Arnesberg, Germany presented on the challenges of treating below-the-knee vascular disease and offered a future perspective on treating BTK and critical limb ischemia. Dr. Lichtenberg has over 20 years of experience in endovascular interventions and served as the Managing Director and President of the German Society for Angiology.
Dr. Thomas Davis, an interventional cardiologist, Director of Cardiovascular Research at St. John Hospital and Medical Center in Detroit, Michigan and Avinger's Chief Medical Officer, provided an overview of the Pantheris SV device and reviewed updated data from the IMAGE-BTK study - a prospective, global, multi-center trial studying the treatment of BTK lesions with Pantheris SV. Pantheris SV, Avinger's proprietary technology for PAD interventions in small diameter peripheral vessels, features an intravascular image-guidance system combined with a targeted plaque excision mechanism for safe and durable outcomes. Dr. Davis has over three decades of clinical practice and leadership in cardiovascular medicine and has pioneered the use of cutting-edge interventional technologies to treat lower extremity arterial disease. He has served on several scientific advisory boards, on faculty at national conferences, as an investigator in multiple clinical trials, and has authored multiple publications.
Dr. Philip Auyang, a board-certified vascular surgeon specializing in both vascular and endovascular surgery in Houston, Texas, shared a case study featuring the minimally invasive treatment of multi-level PAD with Pantheris in a patient with recurrence of a blockage within stents previously placed above-the-knee, and stenoses below-the-knee. He treats all forms of arterial and venous disorders and has authored several publications on the treatment of vascular disease in the Journal of Vascular Surgery and Annals of Vascular Surgery.
In his presentation, Dr. Davis presented updated interim data from IMAGE-BTK, a post-market study designed to evaluate the safety and efficacy of Pantheris SV in below-the-knee procedures, historically an extremely challenging subset of PAD interventions. The study enrolled 51 patients with 58 lesions treated, and now includes follow-up data collected on 45 patients at 6 months and 33 patients at 12 months. In terms of safety, the data showed
Summarizing this exciting new data, Dr. Davis commented, "With over 30 patients now with 12-month follow-up, the promising safety and efficacy data from IMAGE-BTK has reached a point of statistical significance in terms of freedom from target lesion revascularization and primary patency, the gold standard for measuring efficacy of these types of interventions. Pantheris SV, with its onboard image-guidance and directional mechanism of action allows for significant luminal gain while preserving native vessel structures, and has provided unprecedented acute and long-term results for this patient population suffering from a very advanced stage of PAD. This data supports the building evidence that Pantheris SV should serve as a primary interventional platform to address these challenging BTK lesions."
Avinger's Lumivascular technology incorporates an onboard image-guidance system to allow physicians to see inside the artery during an atherectomy or CTO-crossing procedure by using an imaging modality called optical coherence tomography, or OCT. During the procedure, high-resolution intravascular OCT images are displayed on Avinger's Lightbox console in real-time to guide therapy. Physicians performing therapeutic procedures with other devices must rely solely on X-ray images and tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions to deliver safe and effective outcomes, without exposing healthcare workers and patients to the negative effects of ionizing radiation.
About Avinger, Inc.
Avinger is a commercial-stage medical device company that designs and develops the first image-guided, catheter-based system for the diagnosis and treatment of patients with vascular disease in the peripheral and coronary arteries. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox series of imaging consoles, the Ocelot and Tigereye® family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices for the treatment of peripheral artery disease (PAD), estimated to affect more than 200 million people worldwide. Avinger is developing its first product application for the treatment of coronary artery disease (CAD), an image-guided system for CTO-crossing in the coronary arteries, which provides the opportunity to redefine a large and underserved market. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.
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Forward-Looking Statements
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 the results of our IMAGE-BTK study, and anticipated patient and physician benefits of our products, including Pantheris SV. These risks and uncertainties, many of which are beyond our control, include the resource requirements related to our products; the timing and outcome of studies; as well as the other risks described in the section entitled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2024, as amended, and Quarterly Report on Form 10-Q. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward-looking statements.
Investor Contact:
Matt Kreps
Darrow Associates Investor Relations
(214) 597-8200
mkreps@darrowir.com
Public Relations Contact:
Phil Preuss
Chief Commercial Officer
Avinger, Inc.
(650) 241-7900
pr@avinger.com
SOURCE: Avinger, Inc.
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FAQ
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