Embolization, Inc. Achieves FDA Clearance for Innovative Coil Device

Embolization, Inc. Receives FDA Clearance for New Vascular Device

Embolization, Inc. proudly announces its recent achievement in obtaining 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking Nitinol Enhanced Device (NED). With this clearance, the company takes a significant step towards introducing a state-of-the-art vascular embolization device designed for both arterial and venous applications in peripheral vasculature.

Understanding Vascular Embolization

Vascular embolization is a minimally invasive procedure where medical practitioners block a blood vessel intentionally. This is achieved using materials such as coils, particles, or glue to stop bleeding, reduce blood flow to tumors, or obstruct blood flow from abnormal vessels. The method stands out as an alternative to traditional surgical procedures due to its safety, quicker recovery, and precision.

Innovative Design and Benefits of the NED

The NED distinguishes itself with a unique construction utilizing proprietary shape-memory biocompatible polymers. This characteristic reduces artifacts in CT and MRI imaging commonly associated with traditional metal devices. Jim Kasic, CEO of Embolization, emphasizes the importance of this device, calling it a transformative advancement for the medical community and patients alike. He remarked that receiving this clearance enables them to market the NED, allowing for patient accessibility to this innovative technology.

Performance and Operating Advantages

According to Kasic, the NED is set to be the only polymer-based coil currently available, making it a significant competitor against all metal-based alternatives. In pre-clinical studies, these coils have shown remarkable performance that significantly reduces imaging artifacts while still being radiopaque for fluoroscopy procedures. The development of these advanced coils leads to shorter occlusion times, tighter coil packs, and potentially lower recanalization rates.

Clinical Applications and Advantages of Non-Metal Coils

Conditions affecting the peripheral vasculature, including great saphenous insufficiency and renal aneurysms, often require an interruption in blood flow to prevent further complications. Traditionally, surgical ligation was the method of choice, but the emergence of minimally invasive coil insertion has revolutionized treatment options for interventional radiologists.

Advantages Over Traditional Metal Coils

While metal coils have been widely used, they bring some challenges related to imaging interference during CT scans or MRIs, and issues of recanalization could allow unwanted blood flow. Through rigorous animal studies, Embolization's non-metal coils present numerous advantages, including:

• Reduced shadowing in imaging scans
• Enhanced ease of repeat embolizations
• Faster and more reliable embolization results
• Simplified use, thanks to a patented 1mm diameter implantation tool

Commercialization Efforts Following FDA Clearance

With the 510(k) clearance, Embolization is set to advance towards commercializing the NED. Kasic expressed eagerness to engage in the market, pointing out that the global embolization devices sector was valued at approximately $3.1 billion recently and is projected to grow to about $5.9 billion by 2031.

Additionally, the market specifically for embolization coils is expected to expand from around $1.9 billion to nearly $3.7 billion within the same timeframe. The future looks promising for Embolization as it anticipates significant impact and growth within this evolving field.

In collaboration with experts from Boulder iQ and Boulder Regulatory and Quality, Embolization has effectively navigated the development and regulatory terrain for the NED. Together, these firms provide the integrated services essential for life science companies attempting to launch innovative medical solutions.

About Embolization, Inc.

Embolization, Inc. is a forward-thinking medical device company located in Boulder, Colorado. The organization specializes in creating minimally invasive medical devices specifically for the interventional radiology domain, leveraging its expertise in radiopaque shape-memory biocompatible polymers to innovate and lead in the health technology sector.

Frequently Asked Questions

What is the Nitinol Enhanced Device (NED)?

The NED is a vascular embolization device designed to safely block blood vessels using polymer-based technology, minimizing imaging artifacts.

How does the NED compare to metal coils?

The NED utilizes a polymer that reduces imaging interference and improves the reliability of embolization compared to traditional metal coils.

What are the primary benefits of using the NED?

Benefits include shorter occlusion times, less imaging interference, easier repeat embolizations, and reduced manufacturing costs.

Is Embolization, Inc. involved in ongoing research?

Yes, Embolization continues to conduct studies to enhance the design and efficacy of its vascular devices.

When will the NED be available on the market?

Following FDA clearance, Embolization is actively working towards commercialization of the NED to make it available to healthcare providers and patients.

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