Philips receives FDA De Novo Clearance for IVC Filter Removal Laser Sheath - CavaClear - with Breakthrough Device Designation

Rhea-AI Summary

Royal Philips (NYSE: PHG) announced FDA De Novo Clearance for its CavaClear IVC Filter Removal Laser Sheath, marking it as the first FDA-cleared device for advanced IVC filter removal. Designed for patients with embedded filters, CavaClear offers a success rate of over 99% and low complication rates (0.7-2%). Over one million patients in the U.S. could benefit from this innovative solution, addressing high failure rates in filter removals. The technology aims to enhance physician efficiency and reduce clinical risks associated with long-term complications from IVC filters.

Positive

• CavaClear is the first FDA-cleared solution for advanced IVC filter removal.
• Clinical studies show a 96-99.4% success rate with low adverse event rates (0.7-2%).
• Over one million patients in the U.S. could benefit from this technology.
• The device can improve physician efficiency and potentially lower costs.

Negative

• None.

December 22, 2021

• Philips IVC Filter Removal Laser Sheath – CavaClear – is intended to safely ablate tissue to remove embedded IVC filters
• CavaClear is a first-in-class FDA-cleared solution for advanced IVC filter removal
• It is estimated that in the United States more than one million patients with IVC filters would benefit from filter removal to reduce the risk of long-term complications [1,2]
• Two independent and prospective clinical studies demonstrated that laser-assisted retrieval was 96-99.4% effective with a major adverse event rate of 0.7-2% [3,4]

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology today announced the FDA has granted De Novo Clearance for Philips IVC Filter Removal Laser Sheath – CavaClear – to remove an IVC filter when previous methods of removal have failed. CavaClear is the first and only FDA-cleared solution for advanced IVC filter removal. Earlier in 2021, the FDA granted the device Breakthrough Device Designation. Laser has been clinically proven to provide a success rate over 99%, with low complication rates [3].

IVC filters are used to treat patients with venous thromboembolism, in which blood clots form in the deep veins of the leg and groin, and can travel through the circulatory system. They are placed in the inferior vena cava to capture blood clots from moving to the lungs. However, research has shown that IVC filters may have long-term complications [5]. The filters can fracture and travel through the bloodstream to other parts of the body. Other identified long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. The FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated [2].

Failure rates for IVC filter removal can be high and prior to CavaClear, limited options for removal existed if the filter became difficult to remove. Advanced retrieval tools and techniques are required if the IVC filter becomes embedded in the vasculature. Physicians previously had very few tools to remove the filter when complications occurred and until now there were no FDA-approved devices for this type of advanced removal.

“Today is a historic day. With the approval of CavaClear, physicians now have a device specifically geared remove chronically embedded IVC filters,” said Kush R. Desai MD, FSIR, Associate Professor of Radiology, Surgery, and Medicine, and Director of Deep Venous Interventions at Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. “Backed by evidence, this technology can be applied to retrieve IVC filters that are no longer indicated, reducing potential clinical risk for patients and satisfying the FDA’s guidance to retrieve filters when they are no longer indicated.”

Clinical research supports laser-assisted removal
Two independent and prospective clinical studies demonstrated that laser-assisted retrieval was 96-99.4% effective with a major adverse event rate of 0.7-2% [3,4]. Philips CavaClear uses circumferential tissue ablation that can aid in capturing the filter within seconds of laser activation, which can help increase physician efficiency during removal, and may help lower costs by reducing the number of retrieval attempts needed to remove an embedded filter. In addition, the simple and safe design is easy for physicians to integrate into their workflow.  

“With the FDA’s clearance of our IVC Filter Removal Laser Sheath – CavaClear – more than one million patients and their physicians now have access to a safe, effective and efficient option for advanced IVC filter removal,” said Chris Landon, Senior Vice President and General Manager Image Guided Therapy Devices at Philips. “This clearance demonstrates the commitment of Philips to innovating procedures with physician collaboration to meet unmet needs that can have a critical impact on the lives of patients and their families.”

[1] Philips internal market research data calculation.
[2] Health, C. for D. and R. Safety Communications - Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. (2014).
[3] Kuo, W. et al. Laser‐Assisted Removal of Embedded Vena Cava Filters: A First‐In‐Human Escalation Trial in 500 Patients Refractory to High‐Force Retrieval. Journal of the American Heart Association 9:24, 1-9 (2020).
[4] Desai, K. et al. Excimer Laser Sheath-Assisted Retrieval of “Closed-Cell” Design Inferior Vena Cava Filters. J Am Heart Assoc; 9: e017240 (2020).
[5] Van Ha, T. G. Complications of inferior vena caval filters. Semin. Interv. Radiol. 23, 150–155 (2006).

For further information, please contact:

Joost Maltha 
Philips Global Press Office 
Tel: +31 6 10 55 8116  
Email: joost.maltha@philips.com

Fabienne van der Feer
Philips Image Guided Therapy
Tel: + 31 622 698 001
E-mail: fabienne.van.der.feer@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 17.3 billion and employs approximately 78,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Attachments

• Philips IVC Filter Removal Laser Sheath – CavaClear 1
• Philips IVC Filter Removal Laser Sheath – CavaClear 2
• Philips IVC Filter Removal Laser Sheath – CavaClear 3

FAQ

What is the significance of the FDA clearance for Philips' CavaClear?

The FDA clearance for CavaClear establishes it as the first FDA-cleared device for advanced IVC filter removal, which can significantly impact patient safety and treatment efficacy.

How effective is the CavaClear device for IVC filter removal?

CavaClear has demonstrated a success rate over 99% in clinical studies for the retrieval of embedded IVC filters.

What are the risks associated with IVC filters that CavaClear addresses?

CavaClear addresses risks such as filter fracture and long-term complications associated with IVC filters, including deep vein thrombosis and occlusion.

How many patients in the U.S. could potentially benefit from CavaClear?

It is estimated that over one million patients in the United States would benefit from the CavaClear IVC filter removal technology.

What impact does CavaClear have on physician workflow?

CavaClear is designed to integrate easily into physician workflows, potentially increasing efficiency by reducing the number of retrieval attempts needed.