Avinger Initiates Full Commercial Launch of Pantheris LV Image-Guided Atherectomy Device

Rhea-AI Summary

Avinger (NASDAQ:AVGR) has announced the full commercial launch of its Pantheris LV image-guided directional atherectomy system for treating peripheral artery disease (PAD). This follows a successful launch at 16 U.S. clinical centers, involving over 20 interventional physicians. The device features key enhancements including:

- Higher speed plaque excision
- Proprietary jog mechanism for plaque apposition
- Advanced guidewire management system
- Improved tissue packing and removal

Dr. Todd Vogel of University of Missouri Healthcare praised Pantheris LV as the 'interventional tool of choice for most above-the-knee lesions suitable for atherectomy.' Avinger's CEO, Jeff Soinski, highlighted the device's potential to capture market share in above-the-knee procedures, complementing their existing portfolio for PAD treatment.

Positive

• Full commercial launch of Pantheris LV image-guided atherectomy device
• Successful launch at 16 U.S. clinical centers with over 20 physicians
• Key design enhancements for improved efficiency and user operation
• Potential to capture market share in above-the-knee procedures
• Expansion of Avinger's comprehensive suite of image-guided PAD treatment devices

Negative

• None.

Insights

Medical Device Expert

The full commercial launch of Avinger's Pantheris LV image-guided atherectomy device is a significant development in the peripheral artery disease (PAD) treatment landscape. The device's unique selling points include:

• Real-time OCT imaging, reducing reliance on X-rays
• Higher speed plaque excision for efficient tissue removal
• Proprietary jog mechanism for plaque apposition
• Advanced guidewire management system

These features potentially offer improved procedural efficiency and safety. However, market adoption will depend on physician training, reimbursement policies and comparative effectiveness studies against existing treatments. The expanded application to above-the-knee procedures could increase Avinger's addressable market, but competition in this space is intense.

Financial Analyst

Avinger's full commercial launch of Pantheris LV could positively impact the company's financial performance. Key points to consider:

• Potential for increased revenue from expanded market reach
• Possible margin improvements if the new device commands premium pricing
• Initial adoption rates and reorder patterns will be important indicators of success

However, investors should monitor cash burn rates and sales force effectiveness in penetrating new accounts. The company's ability to scale production and manage inventory will be critical. While this launch is promising, Avinger's path to profitability and market share gains against established competitors remain uncertain.

Market Research Analyst

The PAD treatment market is highly competitive, with Avinger facing established players. The Pantheris LV launch could impact market dynamics:

• Potential to disrupt current treatment paradigms with image-guided technology
• May accelerate shift towards minimally invasive procedures
• Could influence pricing strategies of competing devices

Success will hinge on clinical outcomes data and cost-effectiveness compared to alternatives. The initial launch feedback seems positive, but broader market acceptance remains to be seen. Avinger's ability to differentiate its technology and demonstrate clear patient benefits will be important for gaining market share in this competitive landscape.

REDWOOD CITY, CA / ACCESSWIRE / August 20, 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, today announced full commercial launch of the Pantheris LV image-guided directional atherectomy system. With the initiation of full commercial launch, all current and prospective accounts can now order the Pantheris LV device, a line extension of the first and only image-guided atherectomy device for the treatment of peripheral artery disease (PAD).

Prior to full commercialization, Avinger conducted a limited launch at 16 clinical centers in the United States, with over 20 interventional physicians treating patients with the new device. This initial clinical experience validated the key design enhancements incorporated into Pantheris LV, including higher speed plaque excision for efficient removal of challenging occlusive tissue, and multiple design elements to streamline user-operation. These new features include a proprietary jog mechanism for plaque apposition, an advanced guidewire management system, and design enhancements for improved tissue packing and removal.

Dr. Todd Vogel, Chief of Vascular and Endovascular Surgery at University of Missouri Healthcare, commented on his initial clinical experiences with the device, "The Pantheris LV brings the easy-to-use, single-operator design pioneered with Pantheris SV to the larger vessels such as the superficial femoral and popliteal arteries in which the majority of peripheral interventions occur. Having direct experience with a wide variety of large vessel technologies on the market, I would advocate for Pantheris LV as the interventional tool of choice for most above-the-knee lesions suitable for atherectomy."

Jeff Soinski, Avinger's President and CEO, noted, "We designed Pantheris LV with the specific goal to capture above-the-knee procedure volume share from competitive treatment alternatives, modeled after the success of Pantheris SV for below-the-knee cases. The novel features of this product offer multiple benefits to interventionists, by both expanding its clinical application and simplifying its set up and operation. With refreshed designs across our product portfolio, including our portable Lightbox 3 imaging console, we have built a comprehensive suite of next-generation image-guided devices for the treatment of PAD both above-the-knee and below-the-knee, and for challenging conditions such as chronic total occlusions and in-stent restenosis."

Avinger's proprietary 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 Avinger's unique 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 anticipated patient and physician benefits of our products, including Pantheris LV. 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 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 Reports 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.

View the original press release on accesswire.com

FAQ

What is the Pantheris LV device launched by Avinger (AVGR)?

The Pantheris LV is an image-guided directional atherectomy system for treating peripheral artery disease (PAD). It's designed for use in larger vessels such as the superficial femoral and popliteal arteries, focusing on above-the-knee procedures.

What are the key features of Avinger's (AVGR) Pantheris LV atherectomy device?

Key features of the Pantheris LV include higher speed plaque excision, a proprietary jog mechanism for plaque apposition, an advanced guidewire management system, and design enhancements for improved tissue packing and removal.

How many clinical centers were involved in the launch of Avinger's (AVGR) Pantheris LV?

Avinger conducted a launch of the Pantheris LV at 16 clinical centers in the United States, involving over 20 interventional physicians treating patients with the new device.

What technology does Avinger (AVGR) use in its Pantheris LV device?

Avinger's Pantheris LV uses optical coherence tomography (OCT), an imaging modality that allows physicians to see inside the artery during an atherectomy procedure. High-resolution intravascular OCT images are displayed on Avinger's Lightbox console in real-time to guide therapy.